What Rescheduling Will Mean for Marijuana

By Dr. Chris Meyers

The Drug Enforcement Administration announced in early 2024 that it would act on President Joe Biden’s call to reclassify marijuana, moving it from the tightly controlled Schedule I category that it has been in since 1970 to the less restrictive Schedule III status of the Controlled Substances Act. That triggered a long process of hearings and reviews that will not be completed until after the presidential election in November.

The news drew strong reactions from critics: 25 Republican lawmakers sent a letter to Attorney General Merrick Garland protesting any changes to federal marijuana laws. They argued that the decision “was not properly researched … and is merely responding to the popularity of marijuana and not the actual science.”

As a philosopher and drug policy expert, I focus on assessing arguments and evidence rather than politics or rhetoric. So, what are the arguments for and against rescheduling cannabis?

Scheduling Under Controlled Substances Act

The Controlled Substances Act places each prohibited drug into one of five schedules based on known medical use, addictive potential and safety. Schedule I drugs – which, along with marijuana, also includes heroin, LSD, psilocybin, ecstasy (MDMA) and quaaludes – is the most restrictive category.

Schedule I substances cannot be legally used for any purpose, including medical use or research, though an exception for research can be made with special permission from the DEA. The criteria for inclusion in the Schedule I category is that the substance has a high potential for abuse, is extremely addictive and has “no currently accepted medical use.”

Schedule II, which is slightly less restrictive than Schedule I, includes drugs that are addictive and potentially unsafe but also have some accepted medical use. These include strong opioids such as fentanyl, as well as cocaine, PCP and methamphetamine. Though they are still tightly regulated, Schedule II drugs can be used medically with a prescription or administered by a licensed physician.

Schedule III is much less restrictive and is intended for substances with legitimate medical use and only moderate risk of abuse or dependency. This category includes low-dose morphine, anabolic steroids and ketamine.

Schedule IV – which includes the sedative Valium, the weak opioid tramadol and sleep medicines such as Ambien – is even less restrictive.

The least restrictive category is Schedule V, which includes cough syrups with codeine and calcium channel blockers such as gabapentin and pregabalin. All scheduled drugs require a doctor’s prescription and can be distributed only by licensed pharmacies.

Schedule III Would Only Legalize Some Medical Use

The push to reschedule is largely to make federal laws consistent with state medical marijuana programs that – as of October 2024 – are legal in 38 states plus the District of Columbia.

Moving marijuana to Schedule III would not change its legal status in states where it is banned. It would make marijuana legal at the federal level but only for medical use. Recreational use would still be federally prohibited, even though it is currently legal in 24 states plus Washington.

Rescheduling, however, might not make medical marijuana any easier for patients to access and could even make it much harder for some. Currently, getting a medical marijuana card is quite easy in most states. In Washington D.C., where I live, patients can self-certify.

If marijuana is reclassified as Schedule III, medical marijuana programs will have to start requiring a doctor’s prescription, just like with all other scheduled substances. And it could be distributed only by licensed pharmacies, which would put medical dispensaries that are now selling it without a license from the Food and Drug Administration out of business.

Rescheduling, however, would give medical marijuana legitimacy as a bona fide medicine. And the intent of the move is to increase access, even if it is unclear how rescheduling would achieve that.

So, assuming that rescheduling would have the intended effect of expanding access to medical marijuana, should it be rescheduled?

Medical Uses of Marijuana

Though there are three criteria for Schedule I in the Controlled Substances Act, the DEA in fact relies on only the medical use criterion. This was the basis of the DEA’s proposal to reschedule marijuana. The fact that almost 75% of Americans live in a state with a medical marijuana program suggests that marijuana has an accepted medical use.

More importantly, Schedule III of the Controlled Substances Act already includes dronabinol, which is delta-9 THC, the active ingredient in marijuana. Although dronabinol is synthesized in the lab rather than extracted from the cannabis plant, it is the exact same molecule. The FDA approved THC in the form of dronabinol in 1985 for treating anorexia caused by HIV/AIDS as well as nausea and vomiting due to chemotherapy. Placing marijuana in the same schedule as its primary active ingredient makes a lot of sense.

Another argument in favor of rescheduling is that it would open up new opportunities for medical research into marijuana’s effects, research that is currently hampered by its Schedule I status. This work is critical because the system of cannabinoid receptors through which marijuana causes its therapeutic and psychoactive effects is crucial for almost every aspect of human functioning.

Research has shown that cannabis is effective not only in treating nausea and AIDS but also chronic pain and some symptoms of multiple sclerosis.

There is also good evidence that marijuana can help treat other conditions, including Lou Gehrig’s disease (amyotrophic lateral sclerosis, or ALS), glaucoma, irritable bowel syndrome, insomnia, migraine, post-traumatic stress disorder and Tourette syndrome. Keeping marijuana in the Schedule I category severely hampers research that might establish more effective treatments for these conditions.

Balancing Risks and Benefits

Those opposed to rescheduling cite possible health risks associated with marijuana consumption. Heavy use is linked to an increased risk of developing schizophrenia. However, the increased risk of schizophrenia from cannabis use is comparable to that caused by watching excessive television, eating junk food or smoking cigarettes.

Long-term marijuana use can also lead to sleep problems and diminished visuospatial memory. It can also cause gastrointestinal trouble, such as cannabis hyperemesis syndrome, which is characterized by nausea, vomiting and abdominal pain. The symptoms, while extremely unpleasant, are temporary and occur only after consuming marijuana. The condition disappears in people who stop using.

Marijuana use can also be addictive. According to the Centers for Disease Control and Prevention, about three out of every 10 regular marijuana users meet the diagnostic criteria for cannabis use disorder.

All of the concerns above are legitimate, though it is worth noting that virtually no effective medicine is free from undesirable side effects. And although marijuana can be habit-forming, it is not as addictive as alcohol, tobacco, oxycodone, cocaine, methamphetamine or benzodiazepines. None of those other drugs are categorized as Schedule I, and alcohol and tobacco are not scheduled at all.

Unlike most other prescription medications, marijuana use is associated with many benefits. For example, in states where marijuana has been legalized, worker’s compensation payments have fallen by an average of 21% among people over 40. Researchers think that this is because marijuana helps workers better manage chronic pain. The use of marijuana for pain management also helps to reduce dependency on opioids. One study found that U.S. counties with one or two marijuana dispensaries had an average of 17% fewer opioid-related fatalities compared with counties with no dispensaries.

Research also shows that marijuana use can help to prevent Alzheimer’s by blocking the enzymes that produce amyloid plaques. It also shows promise for reducing a person’s risk of developing Type 2 diabetes by helping the body regulate insulin and glucose levels.

All of these benefits add up to marijuana users having an overall lower rate of premature death than nonusers.

Chris Meyers, PhD, is an Adjunct Professor of Philosophy at George Washington University. His main area of research is in moral psychology, moral theory, and applied ethics/public policy. Meyers is the author of “Drug Legalization,” a textbook that looks at the pros and cons of prohibiting recreational drugs.

This article originally appeared in The Conversation and is republished with permission.

Pain Patients More Likely Than Doctors to Favor Greater Access to Cannabis

By Pat Anson

Americans living with chronic pain are significantly more likely to support greater access to cannabis than the physicians who treat them, according to a new survey that found broad support for cannabis education in medical schools.

Rutgers Health surveyed over 1,600 adults with chronic pain and 1,000 physicians in states with medical cannabis programs. The survey results, recently published in JAMA Network Open, show that 71% of  pain patients support federal legalization of medical cannabis, compared to 59% of physicians.

Patients are also more likely to support nationwide legalization of recreational cannabis (55%), compared to about a third of physicians (38%).

"Cannabis is unique in terms of the complicated policy landscape," said lead author Elizabeth Stone, PhD, an Instructor at Rutgers Robert Wood Johnson Medical School. "Depending on what state you're in, it could be that medical cannabis is legal, it could be that medical and recreational use are legal, it could be that neither is legal, but some things are decriminalized.”

Currently, 38 states and Washington, DC have legalized medical cannabis and 23 of those states (plus DC) have legalized its recreational use. Cannabis remains illegal under federal law as a Schedule I controlled substance, but the DEA is considering a proposal from the Biden Administration to reclassify cannabis as Schedule III substance, which would allow for limited use of cannabis-based medication.

Personal experience plays a significant role in shaping attitudes about cannabis. The Rutgers survey found that people who used cannabis for chronic pain had the highest levels of support for expanding access, while physicians who don’t recommended cannabis for pain management had the lowest levels of support.

Although they have different attitudes about legalization, about 70% of patients and physicians favor requiring medical schools to train future doctors on cannabis treatment of chronic pain. There is also broad support for training that would allow physicians and nurse practitioners to recommend cannabis to their patients.  

"I think it points to the need for future guidance around cannabis use and efficacy," Stone said. "Is it something they should be recommending? If so, are there different considerations for types of products or modes of use or concentration?"

Nearly two thirds of patients (64%) and about half of physicians (51%), favor requiring insurance companies to cover cannabis treatment of chronic pain.

Support for Cannabis Policies

JAMA NETWORK OPEN

Previous surveys have also found distinct differences in patient and physician attitudes about cannabis. A recent survey of primary care doctors found that nearly one in five (18%) would not accept a new patient using medical cannabis. And 40% said they would not accept a patient using non-medical or recreational cannabis.

Many doctors are worried what their colleagues will think or what law enforcement will do if they prescribed or recommended cannabis. A 2019 survey of oncologists and pain management specialists found that nearly two-thirds (65%) were concerned about the legal repercussions of recommending medical cannabis to their patients. And 60% were worried about professional stigma.

Many patients who live with chronic pain are turning to cannabis as an alternative to opioids. A recent PNN survey found that over 30% of pain patients said they had used cannabis for pain relief. Many did so because they couldn’t get an opioid prescription or had problems getting one filled.

Should CDC Be Involved in Cannabis Regulation?

By Pat Anson

If you think the Centers for Disease Control and Prevention bungled its handling of COVID-19 tests and misled the public about the risks of opioid pain medication – then you’re probably not going like a new recommendation from a federal advisory panel.     

The National Academies of Sciences, Engineering, and Medicine (NASEM) wants the CDC to play a much larger role in setting federal policy on cannabis, such as expanding its surveillance of cannabis use and establishing “best practices” for states to follow in cannabis regulation.

In other words, a CDC cannabis guideline that would be used as a model for state laws and regulations, much like the agency’s opioid prescribing guideline was. Only this guideline would go much further.

“The best practices should encompass marketing restrictions, age restrictions, physical retail and retail operating restrictions, taxation, price restrictions, product design, and measures to limit youth access,” NASEM said in a 312-page report released this week. “Once the Centers for Disease Control and Prevention’s best practices have been developed, they should be incorporated into the model legislation.”

Cannabis is currently illegal under federal law, but 38 states and the District of Columbia allow its medical and/or recreational use. At the urging of the Biden Administration, the DEA is considering a proposal to reclassify cannabis as a Schedule III controlled substance, which would allow for some medical use of cannabis under federal law. A final decision is not likely until sometime next year.    

But with a major change in federal policy on the horizon and a hodgepodge of state regulations already in place, NASEM wants federal agencies and Congress to get more involved in setting policy for legalized cannabis.

“There is an urgent need for a coordinated public health approach to cannabis policy in the U.S.,” said Steven Teutsch, a senior fellow at the University of Southern California and chair of the committee that wrote the NASEM report. “Our report shows that cannabis policy often focuses on regulating sales and revenue first, and protecting public health second. Now is the time for the federal government to create guidance for states that have legalized cannabis in the interest of protecting the public’s health.”

The first recommendation from NASEM is for Congress to overhaul the regulation of hemp, which was legalized under the 2018 Farm Bill.  That opened the door for cannabis companies to tweak the chemical composition of hemp-derived Delta-8 THC to make it more potent. Intoxicating edibles containing Delta-8 THC are now widely sold as candy, cookies, gummies and beverages – even in states where medical and recreational cannabis are illegal.

NASEM wants Congress to close that loophole by changing the definition of hemp so that Delta-8 THC is regulated the same way as other cannabis products.

Public Health Campaigns

The report also calls for the CDC to develop “targeted public health campaigns” to warn about the risks of cannabis use by children, pregnant women and older adults.  

The latter is one of the fastest growing segments of the population using cannabis, according to a recent survey that found 12% of Americans over 50 had consumed a THC-containing product in the past year. Only 3% were using cannabis in 2006. Ironically, many older adults use cannabis to manage chronic pain because they are no longer able to obtain opioids after the widespread misapplication of the CDC’s opioid guideline.

The NASEM report also warns about the lobbying influence of the cannabis industry, which it blames for the weakening of cannabis regulations in Colorado and Washington, as well as conflicts of interest and “financial entanglements” that some state regulators have with the industry.

“The influence of the burgeoning legal cannabis industry on policy development raises concern about potential bias. Lobbying efforts by the industry have demonstrably impacted regulation,” the report states.

That’s pretty rich when you consider the many biases and conflicts the CDC had when it secretly developed the opioid guideline, and how CDC insiders hijacked a public hearing to silence anyone who might oppose it. Some CDC consultants were later paid millions of dollars testifying as expert witnesses in opioid litigation.

Conservative critics of the CDC are unlikely to support any effort to get the agency involved in cannabis regulation.  The Heritage Foundation’s Project 2025 calls for the CDC’s budget to be slashed and its ability to set healthy policies severely restricted.

“COVID-19 exposed the Centers for Disease Control and Prevention as perhaps the most incompetent and arrogant agency in the federal government,” wrote Roger Severino, former director of the Office for Civil Rights at the Department of Health and Human Services during the Trump administration.

“Never again should public health bureaucrats be allowed to hide information, ignore information, or mislead the public concerning the efficacy or dangers associated with any recommended health interventions.”

A CDC spokesperson told the Associated Press the agency would study NASEM’s recommendations, but more money would be needed to implement them.

Cannabis Advocates Push Back on California Plan to Ban Hemp THC

By Crystal Lindell

The cannabis industry is pushing back on plans by California Gov. Gavin Newsom to impose emergency regulations that would effectively ban all food and beverage products containing Delta-8 tetrahydrocannabinol (THC) derived from hemp.

The proposed regulations would require that any products intended for human consumption have no detectable levels of Delta-8 THC or other intoxicating hemp cannabinoids; establish a minimum age to purchase hemp products at 21; and limit the number of servings of hemp products to five per package.

When hemp was legalized by Congress in 2018, the thinking was that hemp had such minimal amounts of THC that no one could possibly use it to get high. But cannabis companies soon found ways to tweak the chemical composition of hemp-derived THC and other cannabinoids (CBD) to make them more potent. Edibles containing delta-8 THC are now widely sold as candy, cookies, gummies and beverages – even in states where medical and recreational cannabis are still illegal.

“We will not sit on our hands as drug peddlers target our children with dangerous and unregulated hemp products containing THC at our retail stores,” Newsom said in a statement. “We’re taking action to close loopholes and increase enforcement to prevent children from accessing these dangerous hemp and cannabis products.”

But the advocacy group Cal NORML says Newsom’s regulations go too far and would make it impossible to sell any products containing hemp-derived CBD. It wants the rules modified to allow for non-intoxicating levels of THC. . 

“In practice, it’s impossible to eliminate detectable but non-intoxicating traces of THC from natural hemp extracts,” the group said. “THC is readily detectable at levels of 1 billionth of a gram, far below the threshold of human sensitivity.”

Cal NORML says the practical result of Newsom’s proposal would be to ban a host of hemp products that some people use to treat health conditions. It wants California to adopt Colorado’s definition of non-intoxicating hemp. That state allows hemp extracts with a CBD:THC ratio of at least 15:1 and no more than 1.75 milligrams of THC per dose. 

“There’s no danger that minors will try to get high on hemp products with less than 2 mg of THC, especially when other, much more potent marijuana products are readily available at bargain prices on the illegal market,” the group said.

“[Cal NORML] does not take issue with the regulations’ intent to block the sale of hemp products with intoxicating levels of THC in liquor stores, gas stations, smoke shops and convenience outlets, often with inadequate labeling and in a manner accessible to minors.”

As currently drafted, Cal NORML says the proposed regulations would violate the mandate of California’s medical marijuana law to provide “safe and affordable” access to cannabis for all patients in medical need.

Another advocacy group – One Hemp – is threatening a lawsuit against Newsom for exceeding his authority to enact emergency regulations without the approval of the state legislature.

“Newsom’s overreach is shameful,” said Jared Stanley, founding member of One Hemp.  “Other states have successfully banned Delta 8 products while also protecting natural hemp products through a simple solution that would safeguard ALL California’s children, not just some.”

“These rules signify that the Governor intends to turn his back on my daughter and millions in the disabled community,” says Stephanie Bohn, whose 10-year old daughter recently marked one year without seizures after she started taking natural hemp CBD.

“Governor Newsom, please acknowledge children like my daughter – the ones with intractable seizures and debilitating insomnia that conventional pharmaceuticals don't help. The only thing that offered rescue was full-spectrum CBD. This is more than a policy issue, this is a life-or-death issue.”  

One Hemp says parents of disabled children in California are “panic buying CBD products” before the proposed regulations take effect. 

The hemp rules await final approval from the California Office of Administrative Law. If they are approved, sellers of hemp products will be required to immediately impose purchase restrictions and remove items with detectable THC levels.

DEA Delays Decision on Reclassifying Marijuana Until After the Election

By Crystal Lindell

The Drug Enforcement Administration has likely eliminated any possibility of marijuana being rescheduled until after a new president is sworn into office next year. The agency will hold a public hearing on the matter on December 2nd —  nearly a month after the presidential election —  according to a notice published yesterday in the Federal Register. 

The hearing will help determine if marijuana should be re-classified under Schedule III of the Controlled Substances Act (CSA) from its current status as an illegal Schedule I substance. 

Moving marijuana to schedule III would place it in a category of drugs that are considered to have an accepted medical use. Rescheduling would also indicate that cannabis has less potential for abuse than Schedule I and II substances, with only moderate to low risk of physical or psychological dependence. 

But the DEA has also made it clear that rescheduling does not equal legalization, noting that “the manufacture, distribution, dispensing, and possession of marijuana would remain subject to the applicable criminal prohibitions of the CSA.” 

To make a cannabis-based medicine legal under Schedule III, the Food and Drug Administration would first have to approve it for a specific medical condition, which would likely require a lengthy clinical trial process that could take years to complete.

The National Organization for the Reform of Marijuana Laws (NORML), an advocacy organization that has long fought for cannabis to be legalized, says it’s not surprised that the DEA wants to have public hearings. 

“Hearings are an integral part of the rescheduling process. To think that the DEA, which historically has opposed any changes to cannabis’ prohibitive status, would sign off on the most significant proposed change in federal marijuana policy in over fifty years absent such hearings was always wishful thinking,” said NORML Deputy Director Paul Armentano.

“That said, the scientific evidence in favor of removing cannabis from Schedule I remains overwhelming. Cannabis clearly has legitimate therapeutic value and it possesses a superior safety profile compared to other Schedule I or Schedule II controlled substances.”

The Biden Administration initiated the regulatory process to review the scheduling of cannabis in late 2022, a review that has dragged on for nearly two years. The Department of Health and Human Services (HHS) recommended marijuana be moved to Schedule III in August 2023.

But the Justice Department and DEA Administrator Anne Milgram – who has the final say on rescheduling – have yet to approve the HHS recommendation.  The DEA published the proposed change in cannabis’ classification in May in the Federal Register. That notice drew over 43,000 responses during a 60-day public comment period, with numerous requests for a public hearing.

Seeing the process take so long is frustrating. With 38 states and the District of Columbia allowing medical cannabis, it’s clear that marijuana has a legitimate medical use – a fact confirmed by the HHS recommendation to reschedule. So why are the DOJ and DEA dragging their feet?  

Holding the public hearing after the presidential election also risks that it won’t be done at all, depending on who wins and what their policy preference is on the matter. 

Although Democratic nominee Kamala Harris is likely to continue President Joe Biden’s push to have marijuana reclassified, we can’t be sure what she would do. Republican nominee Donald Trump has also indicated in recent days that he favors “decriminalizing” marijuana, but we also don’t know with certainty what he would do. 

With so many states having already legalized the medical and recreational use of marijuana, it’s become increasingly clear that there are no compelling health-related reasons to continue classifying cannabis as a Schedule I controlled substance. And the longer the DEA delays changing marijuana’s status, the more it should make all of us question how much health concern there really is behind the Controlled Substances Act.

Patients and Providers Say Cannabis Helps Reduce Opioid Use

By Crystal Lindell

More than half the pain patients certified in New York state’s medical cannabis program say they’re using cannabis as an alternative to opioid medication. 

That’s great news for patients who see real benefits from cannabis, but we have to be careful to avoid further demonizing opioids when data like this is released. Using something as an alternative doesn’t show that it’s necessarily more effective or more helpful. Often, it just means that something is more accessible. 

The data comes from the New York State Office of Cannabis Management’s 2023 Patient and Provider Survey Report, which was recently released. This was a large survey that collected responses from 10,781 patients and 265 providers enrolled in the state’s medical cannabis program. 

“Findings from both the patient and provider surveys demonstrate that medical cannabis is effective for pain management and has the potential to reduce the use of opioids,” the report found.

About 57% of the patients were pain sufferers, making pain the top condition for using cannabis, followed by post-traumatic stress disorder (24%), neuropathy (19%), spasticity (11%), rheumatoid arthritis (11%), inflammatory bowel disease (10%) and cancer (8%).

The survey found that 66% of patients think medical cannabis helped reduce their use of opioids for pain management.

The providers were largely in agreement, with 83% saying “medical cannabis should be used to reduce the use of opioids for pain management” and 75% saying cannabis poses less risk than opioids. 

However, this is where I start to raise my eyebrow a bit. 

It makes me nervous that so many providers see cannabis as being safer than opioids. The fact that 25% of them don’t is also a telling statistic. It means the data on this is unclear.

All substances have side effects. Both patients and providers understand this. In a just world, patients should be able to make the choice about which substances or medications they use, after factoring in their own preferences for what side effects are acceptable as a tradeoff for pain relief. 

Even if it was proven that cannabis is significantly safer than opioids for managing pain, that doesn’t mean it’s just as effective as opioids. Personally, I don’t find cannabis to be very effective at all for treating my pain. I also really dislike how sleepy it makes me. For my life and my needs, opioids remain a much better option. 

I’m lucky enough to have a recurring prescription for opioid medication. But for patients who can’t get an opioid prescription, they don’t truly get a choice or “alternative.” Cannabis may be their only legal option. 

The New York State report also shows me that it’s long past time to make cannabis legal at the federal level. It’s clear now that classifying cannabis as an illegal controlled substance never had any foundation in health concerns. Clearly, cannabis can help treat a large number of medical conditions. And many people get health benefits from using it. 

A lot of drugs that are classified as harmful controlled substances can still be obtained by prescription. And some that are not “controlled” are potentially more dangerous than cannabis. That doesn’t make any sense, but that’s how the system is set up under the Controlled Substance Act. 

The way that cannabis has been slowly legalized across the country should make us take a long look at all of our drug laws. There are many illegal substances, such as psychedelics, that could potentially help people manage health conditions – but only if they had access to them in the same way most Americans can now access medical or recreational cannabis. 

If nothing else though, cannabis’ slow legalization has given me some hope. I can remember even 25 years ago, being in college, listening to guys in dorm rooms ramble on about how cannabis would be legalized someday. I confess I didn’t believe them. At the time, it felt impossible. 

Turns out, I was wrong. Now I just hope we don’t stop at cannabis. 

Feds Warn About Copycat Packaging of Delta-8 THC Edibles

By Crystal Lindell

The U.S. government is once again going after companies that sell Delta-8 THC edibles in packaging that looks like popular brand name candy and snacks. 

The Food and Drug Administration and the Federal Trade Commission sent warning letters to five companies for selling copycat food products containing delta-8 THC derived from hemp.

For example, one company was selling a package of “Slizzles” edibles that looks strikingly similar to “Skittles” candy. Another company sold a “Double Stuff Stoneo” product in packaging that looks like “Oreo” cookies. 

The cease and desist warning letters were issued to Hippy Mood, Earthly Hemps, Shamrockshrooms, Mary Janes Bakery and Life Leaf Medical CBD Center. 

“Inadequate or confusing labeling can result in children or unsuspecting adults consuming products with strong resemblance to popular snacks and candies that contain delta-8 THC without realizing it,” FDA Principal Deputy Commissioner Namandjé Bumpus, PhD, said in a statement. 

“As accidental ingestion and/or overconsumption of Delta-8 THC containing products could pose considerable health risks, the companies who sell these illegal products are demonstrating complete neglect for consumer safety.”

Delta-8 THC is derived from hemp, which Congress legalized in the 2018 Farm Bill. Hemp contains only trace amounts of THC, the psychoactive ingredient in cannabis, so the thinking was that hemp would only be used to make cash products such as rope, clothing and horse feed. It didn’t take long, however, for cannabis companies to develop a synthetic form of hemp-derived THC that is just as potent as regular THC. 

Efforts are underway to close that loophole in the next Farm Bill, but in the meantime delta-8 THC products remain legal under federal law, although some individual states have banned them. 

In 2022 and 2023, the feds issued similar warnings against other companies marketing Delta-8 THC edibles. Although those products were withdrawn from the market, other companies have stepped into the void and began selling similar ones. 

The FDA and FTC say the copycat branding of delta-8 edibles violates federal laws against unfair or deceptive marketing, including practices that present health or safety risks. The agencies say children are particularly vulnerable, because they might not realize the edibles contain THC. 

“Companies that market and sell edible THC products that are easily mistaken for snacks and candy are not only acting illegally, but they are also putting the health of young children at risk,” said Samuel Levine, director of the FTC’s Bureau of Consumer Protection. “Those that prioritize profits in front of children's safety are at serious risk of legal action.”

Industry groups that represent companies that have seen their branded products mimicked have come out against this type of copycat packaging.  The Consumer Brands Association (CBA) has a position paper on its website specifically addressing THC edibles that mimic popular brands. 

“Companies are unequivocally opposed to their brands being illegally used in products containing THC,” the CBA writes. “But rooting out these bad actors is like a game of whack-a-mole. By the time a company or government entity goes after them, their local storefront or online presence disappears and they pop up with a new name and new site.”

The issue goes beyond simple copyright infringement. The CBA cites recent data showing that national poison control centers handled nearly 10,500 incidents involving products laced with THC. Of those cases, 77% involved consumers 19 years old or younger.

“The urgency of this issue is not about intellectual property infringement, but about how that infringing use of trusted food brands creates a direct threat to consumer safety — particularly that of children,” the CBA says. “As incidents of children being hurt by lookalike products that endanger them increase, greater enforcement is necessary.”

The National Confectioners Association (NCA) has also warned about cannabis companies using packages that looks like popular candy and snacks.

Edibles may deliberately mimic the trade dress of beloved consumer brands,” the NCA said. “It is often very difficult to distinguish these edibles from conventional foods and beverages, resulting in confusion and injury to consumers, including children, and reputational damage to food companies.”

The NCA says it is difficult and costly for companies to try to protect their brands in this situation, because it requires “state-by-state surveillance” and “burdensome legal action.”

The FDA is also concerned about the processes used to synthesize delta-8 THC, as impurities or variations in the processing can result in products that may be harmful or have unpredictable effects. The agency has requested written responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. 

Many Doctors Hesitant to Accept Patients Using Opioids or Cannabis

By Crystal Lindell

Chronic pain patients who use either opioids or cannabis are still finding it hard to find new primary care physicians, according to new research at the University of Michigan.

Lead author Mark Bicket, MD, and his colleagues surveyed more than 1,000 U.S. primary care physicians about whether they were accepting new patients with chronic non-cancer pain. The physicians were all based in states with medical cannabis programs.

Of the 852 physicians who said they were taking new patients, 20% said they would not accept patients taking prescription opioids. Nearly a third (32%) said they would not accept a patient using opioids daily.

In contrast, only 18% of doctors said they would not take a pain patient using medical cannabis. And 40% said they would not accept a patient using cannabis “obtained from other sources” — meaning the cannabis probably came from the black market.

Primary Care Doctors Willing to Take New Patients Using Opioids or Cannabis

HEALTH AFFAIRS SCHOLAR

“There’s a group of legacy patients with chronic pain who have been on long-term opioids for some time, and they may have to find a doctor, maybe because they’ve moved or their doctor has retired,” said Bicket, who is an anesthesiologist and pain researcher at Michigan Medicine. “For those patients in particular, finding someone else to help with their care is challenging.”

Making matters worse, pain patients are at higher risk of having a substance problem if they don’t have access to pain medication.

“This lack of access could inadvertently encourage patients to seek nonmedical treatments for their chronic pain, given that relief of pain is the most commonly reported reason for misuse of controlled substances,” Bicket wrote. “I empathize a lot with the patients, as well as the prescribers out there, trying to treat people in pain because we’re trying to do the right thing, and yet, we’re flying in the dark when it comes to having access to high quality evidence to guide next steps for cannabis and opioids.”

While the study didn't assess the reasons for physician reluctance, it adds to a growing body of evidence that patients using cannabis or opioids have less access to care. 

In a 2019 PNN survey of nearly 6,000 chronic pain patients, almost three out of four (72%) said it was hard to find a doctor willing to treat their pain. More than a third of patients (34%) said they’ve been abandoned by a doctor and 15 percent said they haven’t been able to find a doctor at all.

That same year, another survey by researchers at the University of Michigan found that only 40% of primary care practices would take a new patient on opioids. That survey used a "secret shopper" method, with researchers posing as the adult children of patients taking the opioid Percocet calling primary care clinics in Michigan to see if they could schedule an appointment for their parent.

Less than half of the clinics (41%) were willing to schedule an initial appointment and 17 percent said they needed more information before making a decision.

Rates of Cannabis Use Disorder Rising for Medicare Patients

By Pat Anson

A new FDA study is documenting the growing use of cannabis by seniors and how some are being diagnosed as having “cannabis use disorder” by their doctors.

A research team led by FDA epidemiologist Silvia Perez-Vilar, PharmD, analyzed the health data of nearly 56 million Medicare beneficiaries aged 65 and older. They looked for Medicare claims that included at least one of the many billable diagnostic codes for cannabis use disorder (CUD).

There are over three dozen such codes, which include everything from cannabis intoxication and dependence to delusions, psychosis and “perceptual disturbance” – a diagnosis that can mean anything from not being able to recognize words to seeing things that aren’t there. There are even CUD codes for “unspecified” symptoms of cannabis use and for being in remission.

The research findings, recently published in JAMA Network Open, found that Medicare claims for CUD have steadily risen in recent years, especially in states where cannabis was legalized for medical or adult recreational use.

“Rates of cannabis-related disorder encounters increased from 2017 through 2022 among US Medicare-insured older adults. We observed the highest rates in states or territories that legalized adult and medical use of cannabis,” they wrote. “Overall, data suggest that increasing rates of health care encounters documenting cannabis-related disorders among older adults might be associated with the type of cannabis legalization.”

What were these “increasing rates” documenting CUD? In states where cannabis is legal, about 45 CUD cases were filed in 2022 for every 10,000 Medicare claims. That’s about 0.45% of all claims – not a large amount by any means. The CUD rate was even lower in states where cannabis is illegal, less than 0.28%.

Those may be rock bottom rates, but the researchers noted that “differences in cannabis use patterns and perception of risk may influence policy changes.” Exactly what kind of policy changes are warranted aren’t spelled out, but it implies there should be more screening for CUD.  

Another recent JAMA study called for U.S. primary care physicians to start screening all patients for CUD, regardless of age or even whether they currently use cannabis. Patients identified as high risk cannabis users should then be referred for “possible addiction treatment.”

Treatments for CUD are currently limited to counseling and cognitive behavioral therapies. Unlike opioid use disorder, there are no FDA-approved pharmaceutical treatments for CUD, although there are several such drugs in the pipeline. One is being tested in clinical studies by Indivior, the company that makes Suboxone for opioid use disorder.

Cannabis vs. Opioids

Many patients who live with pain are turning to cannabis as an alternative to opioids, which are increasingly difficult to obtain. In a recent PNN survey, over 30% of pain patients said they had used cannabis for pain relief. Many did so because they couldn’t get an opioid prescription or had problems getting one filled.

“I have a medical marijuana referral and my doctor at the Cleveland Clinic flat out refuses to write me any prescriptions for any opioids. Bunch of BS,” one patient told us.

“I am very lucky. My pain management doctor supports medical cannabis,” said another. “Since my (opioid) dose has been cut in half, it does provide a bit of relief and helps me sleep a few hours.”

“My pharmacy ran out of oxycodone & hydrocodone. My pain doctor switched me over to hydromorphone and so far I've been able to get that filled. If I'm no longer able to get that, I'll have to consider medical marijuana,” wrote another pain patient.

About 10% of U.S. adults over age 50 reported using cannabis within the past year, a number that’s expected to rise when the federal government reschedules cannabis as a less dangerous drug. As more seniors experiment with cannabis, they’ll have to get used to the fact that it carries a stigma, just like opioids. And there’s a good chance their doctor will be evaluating them for signs of CUD.  

“Many older adults are turning to cannabis for help with increased pain syndromes—osteoarthritis, degenerative joint diseases, as well as insomnia,” Brooke Worster, MD, an associate professor and cannabis expert at Thomas Jefferson University, told Fortune.   

“The question really is, how do we recognize and avoid abuse or CUD, which is important and only now being recognized and discussed in the medical community more regularly.” 

Should Every Patient Be Screened for Cannabis Use Disorder?

By Pat Anson, PNN Editor

With the federal government on the verge of rescheduling cannabis as a less dangerous drug, and 38 states and the District of Columbia already allowing its medical and/or recreational use, it seems likely we’ll be hearing a lot more about cannabis use disorder.

A case in point is a large study, recently published in JAMA Network Open, that calls on primary care physicians to start screening all patients for cannabis use disorder (CUD).  It’s estimated that about 14.2 million Americans have CUD, a number that’s expected to grow as legal cannabis becomes more widely available.

The study found that 17% of primary care patients reported using cannabis in the last three months, usually to manage pain and other symptoms. Researchers say over a third of them (34.7%) used cannabis so frequently they were at moderate to high risk of CUD.

"Given the high rates of cannabis use, especially for symptom management, and the high levels of disordered use, it is essential that health care systems implement routine screening of primary care patients," wrote lead author Lillian Gelberg, MD, from the UCLA David Geffen School of Medicine.

“This group could benefit from a primary care clinician–based brief intervention to prevent those at moderate risk for cannabis use disorders from developing more serious CUD and to evaluate and refer high-risk users for possible addiction treatment.”

What is cannabis use disorder and how is it assessed? For the UCLA study, researchers used a screening tool known as ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) that was originally developed by the World Health Organization and then modified to include cannabis.

Patients were asked if they’ve used cannabis in the last three months. If they said “yes,” five more questions were asked to assess why they use cannabis; how often they use it; if they’ve experienced tolerance or withdrawal; if they’ve tried unsuccessfully to reduce or stop using cannabis; and if it has interfered with any aspect of their lives.

Answer “yes” to one or two of those additional questions and a patient could then be diagnosed with CUD, even if they’ve used cannabis safely and responsibly for years. Their doctor could then select from dozens of diagnostic codes for CUD, ranging from cannabis dependence and intoxication to psychosis and hallucinations. All of the codes are billable for the doctor, so there is an incentive to use them.

Critics say this way of diagnosing people with CUD is fraught with problems, not unlike the way many pain patients have been diagnosed with opioid use disorder and forced into addiction treatment.

“This is my take too,” says Paul Armentano, Deputy Director of NORML, which advocates for full marijuana legalization. “Given that more than three-quarters of the (UCLA) cohort acknowledged consuming cannabis products ‘to manage symptoms,’ it’s hardly surprising that many if not all of these respondents would also report long-term regular use of the substance, as well as other criteria that overlap with signs of so-called cannabis use disorder.”

Armentano says several studies have documented declines in CUD, even after states legalized cannabis use.  

“To date, not a single legalization state has ever repealed or even rolled back their marijuana laws. This speaks to the reality that these regulations are working largely as intended and that the majority of those who consume cannabis do so in a responsible manner that poses little risk to either themselves or to others,” Armentano said in an email. 

In Washington State, one of the first states to legalize recreational cannabis, a recent study estimated that one in every five primary care patients had CUD, with 6.5% having moderate to severe CUD. Like the UCLA study, researchers said their findings underscore “the importance of assessing patient cannabis use in clinical settings.” 

“Knowledge of patient use provides an opportunity to discuss risks and limited benefits of cannabis use and potentially safer treatment alternatives for those using cannabis for medical reasons. For patients with higher risk cannabis use (eg, daily), psychometrically valid brief assessments for (diagnostic) symptoms of CUD can identify and gauge CUD severity,” they concluded. 

CUD Medications in the Pipeline

Treatments for CUD are currently limited to counseling and cognitive behavioral therapies such as meditation. Unlike opioid use disorder, there are no FDA-approved pharmaceutical treatments for CUD. That could soon be changing, as more drug companies recognize the potential value of CUD medication to their bottom lines.  

Indivior, the maker of Suboxone and Subutex for treatment of opioid use disorder, is conducting clinic trials on a synthetic drug -- called AEF0117 – that is designed to treat CUD by inhibiting a cannabinoid receptor in the brain that makes people feel “high.”

Indivior bought the worldwide rights to AEF0117 from a French pharmaceutical company for $100 million — which tells you how much value they think the drug could have. Indivior executives call AEF0117 “a unique opportunity to address a growing unmet public health need.”

“We have tested over a dozen potential treatment medications in our Cannabis Research Laboratory, and this is the first to decrease both the positive mood effects of cannabis and the decision to use cannabis by daily smokers,” said Margaret Haney, PhD, a professor of neurobiology at Columbia University who supervised the trials for Indivior.

According to ClincalTrials.gov, over a hundred clinical trials are currently underway or recruiting participants for a variety of potential CUD therapies. Most are treatments that already exist for other conditions and would be repurposed for CUD. One is gabapentin, a nerve drug currently used to treat seizures, shingles and pain. Other treatments being tested for CUD include transcranial magnetic stimulation, high blood pressure medication, and drugs used to help people stop smoking tobacco. 

Another anecdotal sign about the growing awareness of CUD can be found in the Federal Register, which has received over 17,000 comments so far about the Justice Department’s proposal to reclassify marijuana as a less restrictive Schedule III substance.

Nearly 700 of the comments mention CUD, with many containing boilerplate language claiming that “1 in 3 past year marijuana users met the clinical criteria for Cannabis Use Disorder.”

That theme is widely promoted by the addiction treatment industry, which maintains there is no clinical evidence “that the therapeutic benefits of medical cannabis or medical marijuana outweigh the health risks.”

There are currently no established medical guidelines or a “standard of care” that specifically address how to screen for CUD. But with cannabis use growing and healthcare providers coming under scrutiny for how they deal with substance abuse issues, future guidelines that require doctors to screen for CUD may be inevitable.

“How much longer will clients, families, social workers, and other mental health clinicians continue to be shortchanged by this situation? The time is well overdue to undertake formal cannabis use screening with well-established instruments during the mental health intake evaluation process, especially with adolescents and young adults,” wrote Jerrold Pollak, PhD, a clinical neuropsychologist, in Social Work Today.

One of the biggest hurdles for routine CUD screening may be patient reluctance to discuss their cannabis use. A survey of older U.S. adults found that less than 40% had discussed their cannabis use with a healthcare provider. Many fear being dropped by their doctor or being cut off from medication if they disclose that they’re using cannabis.

A Compound Found in Cannabis Could Make Opioids Safer

By Pat Anson, PNN Editor

What gives the cannabis sativa plant it’s pain-relieving properties?

Most people will tell you it’s cannabidiol (CBD) and/or tetrahydrocannabinol (THC), the two most well-known chemical compounds found in cannabis.  

But researchers at University of Arizona Health Sciences say terpenes -- aromatic compounds that give cannabis its distinctive “skunky” smell – have analgesic effects as well. In fact, in a new study published in the journal PAIN, they report that cannabis terpenes are just as effective as morphine in reducing neuropathic pain in laboratory animals.

“A question that we’ve been very interested in is could terpenes be used to manage chronic pain?” lead researcher John Streicher, PhD, a Pharmacology Professor at UA’s College of Medicine in Tucson, said in a press release. “What we found is that terpenes are really good at relieving a specific type of chronic pain with side effects that are low and manageable.”

Terpenes are found in all plants and are the main component of essential oils. Terpenes give lavender, sage and eucalyptus oils their distinctive smells, which are used to promote relaxation or even reduce pain and inflammation. In nature, terpenes help plants attract pollinators such as bees or to protect themselves from predators.

Most plants have only two dominant terpenes, but cannabis has up to 150 terpenes. Streicher and his colleagues tested five of the cannabis terpenes by injecting them into mice with chemotherapy-induced neuropathic pain.

They found that each of the five terpenes reduced nerve pain significantly, at levels similar to or even better than morphine. And when combined with morphine, the analgesic effects were enhanced even further.

Perhaps the most striking discovery is that the mice showed no signs of euphoria or “liking” terpenes – a sign that they may not have abuse potential.

“We looked at other aspects of the terpenes, such as: Does this cause reward? Is this going to be addictive? Is it going to make you feel awful?” Streicher said. “What we found was yes, terpenes do relieve pain, and they also have a pretty good side effect profile.”

In addition to injections, researchers also administered terpenes to the mice orally and through inhalation from a vaporizer. The results were the same. The mice had significant pain relief with no side effects or signs of addiction.

More research is needed, but some cannabis companies are already incorporating terpenes into their products. Lemon Kush, for example, is a marijuana strain that contains limonene, a terpene that smells like lemon, while the hybrid Blue Dream has a terpene that’s also found in blueberries.

“A lot of people vape or smoke terpenes as part of cannabis extracts that are available commercially in states where cannabis use is legal,” Streicher said “We were surprised to find that the inhalation route didn’t have an impact in this study, because there are a lot of at least anecdotal reports saying that you can get the effects of terpenes whether taken orally or inhaled.”

The next step for Streicher and his research team is to study whether terpenes can block the abuse potential of opioids, while at the same time enhancing their analgesic effects.

“This brings up the idea that you could have a combination therapy, an opioid with a high level of terpene, that could actually make the pain relief better while blocking the addiction potential of opioids,” Streicher said.

Cannabis Oil Provides ‘Modest’ Pain Relief

By Pat Anson, PNN Editor

Cannabis can be consumed in many different forms for pain relief. You can smoke or vape cannabis flowers, rub cannabis-infused lotions and ointments on your skin, or ingest edibles and beverages containing cannabidiol (CBD) and/or tetrahydrocannabinol (THC), the active ingredients in cannabis.

But it’s cannabis oil that is increasingly cited in research as providing the most benefit for pain sufferers.

The latest study was conducted in Israel, involving about 200 middle-aged adults with chronic pain who were treated by a specialist for at least one year without satisfactory pain relief before trying cannabis. Participants suffered from a variety of pain conditions, including nerve pain, joint pain and headaches. Their average pain level at the start of the study was 7.9 on a zero-to-10 pain scale.

For 6 months, participants ingested cannabis oil extracts daily in a variety of different THC and CBD concentrations, all prescribed by a physician, which were consumed sublingually under the tongue. The doses were considerably lower than what you’d get from smoking or vaping.

By the end of the study, the average pain level among participants had dropped from 7.9 to 6.6, equivalent to a 14% reduction in pain, with similar improvements in sleep, anxiety, depression, disability, and quality of life.

“All these effects are modest in size but are rather consistent and congruent with those found in additional cohorts. Hence, cannabis seems to have an impact on the ‘disease burden’ of chronic pain rather than being a potent analgesic per se,” lead author Dorit Pud, PhD, a Nursing Professor at the University of Haifa, reported in the journal Pain Reports.

‘Taken together, these observational cohorts suggest that in practice, much lower doses of oil extracts of cannabis are used compared with inflorescence (smoking or vaping). It therefore seems that oil extracts may be advantageous over inflorescence as they allow more precise dosing, lower THC dose consumption, and comparable analgesia.”

The number of patients consuming opioids decreased over the course of the study, but because the doses were low and only a minority were taking them, researchers were reluctant to draw conclusions about the opioid-sparing effects of cannabis.

The research team noted that about a quarter of the patients had a 30% or more reduction in pain, but they were unable to determine why these “responders” had better results than others. About half the participants had an adverse side effect from cannabis oil, such as dizziness or confusion, but those symptoms usually declined after the first month.

Previous studies have also found cannabis oil effective in treating pain. Researchers in Columbia say 92% of patients reported less pain after consuming a proprietary formulation of oil containing CBD and THC. Similar findings were reported in a recent study in Australia. Other studies have found cannabis oil effective in treating fibromyalgia and migraine.

Public Comments Sought on Marijuana Rescheduling

By Pat Anson, PNN Editor

The U.S. public is finally getting a chance to comment on the federal government’s historic decision to reclassify marijuana from a Schedule I substance with a “high potential for abuse” to a less restrictive Schedule III drug with “moderate to low potential for physical and psychological dependence.”

After months of foot dragging, the Justice Department published a notice in the Federal Register today giving the public 60 days to comment on the proposed rescheduling. Written comments must be submitted or postmarked on or before July 22. Online comments can be made here.

Every step in this process has been fraught with delays. And there may be more.

The Food and Drug Administration completed a review last August – nearly a year after it was requested by President Biden -- finding “credible scientific support” for marijuana’s rescheduling. But the FDA report was not made public until January, after a lawsuit was filed by two pro-cannabis lawyers seeking its release when the agency didn’t respond to requests under the Freedom of Information Act (FOIA).

Another four months passed before the Justice Department, which oversees the Drug Enforcement Administration, submitted to the Federal Register a notice about the proposed rescheduling. Since the DEA is charged with enforcing the Controlled Substances Act (CSA) and determines how drugs are scheduled, public notices involving the CSA are almost always signed by the DEA administrator.

This one, however, is signed by Attorney General Merrick Garland, not DEA Administrator Anne Milgram – a sign that her agency is not yet on board with marijuana’s rescheduling.

“DEA has not yet made a determination as to its views of the appropriate schedule for marijuana,” Garland wrote. “The CSA vests the Attorney General with the authority to schedule, reschedule, or decontrol drugs… The Attorney General has delegated that authority to the DEA Administrator, but also retains the authority to schedule drugs under the CSA in the first instance.”

According to an Associated Press report, Milgram told her staff in March that marijuana’s rescheduling “had been taken over” by Garland and the DOJ. The DEA wanted more time for studies to determine whether marijuana has an accepted medical use, a request that was rejected.

Former DEA Administrator Tim Shea believes the rescheduling process was hijacked by DOJ for political reasons.

“If she (Milgram) had supported it she would have signed it and sent it in,” Shea told the AP. “DEA was opposed to this and the politics entered and overruled them. It’s demoralizing. Everybody from the agents in the streets to the leadership in DEA knows the dangers this brings.”   

Asked recently during a congressional hearing what her views are on marijuana. Milgram ducked the question.

“Since DEA is ultimately the decider of scheduling and rescheduling, and the DEA administrator is in that role, it would be inappropriate for me to make comments about this process or parts of that process,” Milgram said.

‘Evidence Supports Marijuana for Pain’

Reclassifying marijuana as a Schedule III substance – in the same category as codeine and ketamine – may be historic, but it’s not the full “legalization” that many cannabis supporters have been calling for.  

Under the CSA, legal access to Schedule III substances requires a prescription from a licensed doctor that is filled at a licensed pharmacy. Any new medical marijuana products would also have to go through a lengthy and costly clinical trial process to assess their safety and effectiveness. Even if they pass that test, they would likely only be approved by FDA for certain conditions.  

Garland’s notice in the Federal Register is largely based on the FDA’s 2023 review, which states there is good evidence that marijuana is helpful in treating chronic pain and mixed evidence it could be useful in relieving nausea, anxiety, epilepsy and PTSD.

“FDA’s review of the available information identified mixed findings of effectiveness across indications, ranging from data showing inconclusive findings to considerable evidence in favor of effectiveness, depending on the source. The largest evidence base for effectiveness exists for marijuana use within the pain indication (in particular, neuropathic pain). Numerous systematic reviews concluded that there exists some level of evidence supporting the use of marijuana for chronic pain,” Garland wrote.

As for marijuana’s potential for abuse, Garland cited findings that marijuana poses less of a health risk than illicit drugs and even some legal medications such as oxycodone and benzodiazepines.

“The rank order of the comparators in terms of greatest adverse consequences typically ranked heroin, benzodiazepines, and cocaine first or in immediately subsequent positions, with marijuana in a lower place in the ranking,” Garland wrote.

“For overdose deaths, marijuana is always in the lowest ranking among comparator drugs. These evaluations demonstrate that there is consistency across databases, across substances, and over time. HHS thus concluded that although abuse of marijuana produces clear evidence of a risk to public health, that risk is relatively lower than that posed by most other comparator drugs.”

The opening of a public comment period does not mark the end of the rescheduling process. The DEA/DOJ will need time to review and evaluate thousands of comments, which will be followed by an administrative hearing and a final ruling that is subject to presidential review. Even then, the final rule has to be published in the Federal Register, followed by a 30 or 60-day wait period before the rule takes effect. 

During that process, and until a final rule is published, marijuana remains a schedule I controlled substance that is illegal under federal law. About three-quarters of states have already legalized marijuana for medical or recreational purposes.

Regulations Should Be Eased for Cannabis and Psilocybin

By Dr. Kevin Boehnke  

The U.S. Drug Enforcement Agency announced in late April 2024 that it plans to ease federal restrictions on cannabis, reclassifying it from a Schedule I drug to the less restricted Schedule III, which includes drugs such as Tylenol with codeine, testosterone and other anabolic steroids. This historic shift signals an acknowledgment of the promising medicinal value of cannabis.

The move comes in tandem with growing interest in the use of psilocybin, the active component in magic mushrooms, for treatment of depression, chronic pain and other conditions. In 2018 and 2019, the U.S. Food and Drug Administration granted a breakthrough therapy designation to psilocybin, meant to expedite drug development given that preliminary studies suggest it may have substantial therapeutic value over currently available therapies for treatment-resistant depression and major depressive disorder.

Both of these developments represent a dramatic change from long-standing federal policy around these substances that has historically criminalized their use and blocked or delayed research efforts into their therapeutic potential.

As an assistant professor of anesthesiology and a pain researcher, I study alternative pain management options, including cannabis and psychedelics.

I also have a personal stake in improving chronic pain treatment: In early 2009 I was diagnosed with fibromyalgia, a condition characterized by widespread pain throughout the body, sleep disturbances and generalized sensory sensitivity.

I have seen and experienced firsthand the ways that clinicians and patients talk about chronic pain medications, and find them to generally be disempowering to the patient, clinician, and drugs themselves. My goal in this article is to help provide a new and more useful lens to think about medications, especially given the poor treatment outcomes for people with chronic pain, the frustration providers express about treating these ‘challenging patients,’ and the ongoing opioid overdose crisis.

I see cannabis and psilocybin as promising therapies that can contribute to bridging that need. Given that an estimated 50 million Americans have chronic pain – meaning pain that persists for three months or more – I want to help understand how to effectively use cannabis and psilocybin as potential tools for pain management.

Cannabis History

Cannabis, also known as marijuana, is an ancient medicinal plant. Cannabis-based medicines have been used for at least 5,000 years for applications such as arthritis and pain control during and after surgery.

This use extended through antiquity to modern times, with contemporary cannabis-based medications for treating certain seizure disorders, promoting weight gain for HIV/AIDS-related anorexia and treating nausea during chemotherapy.

As with anything you put in your body, cannabis does have health risks: Driving while high may increase risk of accidents. Some people develop cyclical vomiting, while others develop motivation or dependence problems, especially with heavy use at younger ages.

That said, lethal overdoses from cannabis are almost unheard of. This is remarkable considering that nearly 50 million Americans use it each year.

In contrast, opioids, which are often prescribed for chronic pain, have contributed to hundreds of thousands of overdose deaths over the past few decades. Even common pain medications like nonsteroidal anti-inflammatory drugs, such as ibuprofen, cause tens of thousands of hospitalizations and thousands of deaths each year from gastrointestinal damage.

Furthermore, both opioids and nonopioid pain medications have limited effectiveness for treating chronic pain. Medications used for chronic pain can provide small to moderate pain relief in some people, but many ultimately cause side effects that outweigh any gains.

These safety issues and limited benefit have led many people with chronic pain to try cannabis as a chronic pain treatment alternative. Indeed, in survey studies, my colleagues and I show that people substituted cannabis for pain medications often because cannabis had fewer negative side effects.

However, more rigorous research on cannabis for chronic pain is needed. So far, clinical trials – considered the gold standard – have been short in length and focused on small numbers of people. What’s more, my colleagues and I have shown that these studies employ medications and dosing regimes that are far different from how consumers actually use products from state-licensed cannabis dispensaries. Cannabis also causes recognizable effects such as euphoria, altered perceptions and thinking differently, so it is difficult to conduct double-blind studies.

Despite these challenges, a group of cannabis and pain specialists published a proposed guideline for clinical practice in early 2024 to synthesize existing evidence and help guide clinical practice. This guideline recommended that cannabis products be used when pain is coupled with sleep problems, muscle spasticity and anxiety. These multiple benefits mean that cannabis could potentially help people avoid taking a separate medication for each symptom.

Since the Controlled Substance Act was passed in 1970, the federal government has designated cannabis as a Schedule I substance, along with other drugs such as heroin and LSD. Possession of these drugs is criminalized, and under the federal definition they have “no currently accepted medical use, with a high potential for abuse.” Because of this designation and the limits placed on drug manufacturing, cannabis is very difficult to study.

State and federal regulatory barriers also delay or prevent studies from being approved and conducted. For example, I can purchase cannabis from state-licensed dispensaries in my hometown of Ann Arbor, Michigan. As a scientist, however, it is very challenging to legally test whether these products help pain.

Reclassifying cannabis as a Schedule III drug has the potential to substantially open up this research landscape and help overcome these barriers.

Emerging Role of Psychedelics

Psychedelics, such as psilocybin-containing mushrooms, occupy an eerily similar scientific and political landscape as cannabis. Used for thousands of years for ceremonial and healing purposes, psilocybin is also classified as a Schedule I drug. It can cause substantial changes in sensory perception, mood and sense of self that can lead to therapeutic benefits. And, like cannabis, psilocybin has minimal risk of lethal overdose.

Clinical trials combining psilocybin with psychotherapy in the weeks before and after taking the drug report substantial improvements in symptoms of psychiatric conditions such as treatment-resistant depression and alcohol use disorder.

Risks are typically psychological. A small number of people report suicidal thoughts or self-harm behaviors after taking psilocybin. Some also experience heightened openness and vulnerability, which can be exploited by therapists and lead to abuse.

There are few published clinical trials of psilocybin therapy for chronic pain, although many are ongoing, including a pilot study for fibromyalgia conducted by our team at the University of Michigan. This treatment may help people develop a healthier relationship with their pain by eliciting greater acceptance of it and decreasing rumination often related to negative thoughts and feelings around pain.

As with cannabis, some states, such as Colorado and Oregon, have decriminalized psilocybin and are building infrastructure to increase accessibility to psilocybin-assisted therapy. One recent analysis suggests that if psychedelics follow a similar legalization pattern to cannabis, the majority of states will legalize psychedelics between 2034 and 2037.

Challenges Ahead

These ancient yet relatively “new” treatments offer a unique glimpse into the messy intersection of drugs, medicine and society. The justifiable excitement about cannabis and psilocybin has led to state policies that have increased access for some people, yet federal criminalization and substantial barriers to scientific investigation remain. In the years ahead, I hope to contribute toward pragmatic studies that work within these difficult parameters.

For example, our team developed a coaching intervention to help veterans use commercially available cannabis products to more effectively treat their pain. Coaches emphasize how judicious use can minimize side effects while maximizing benefits. Should our approach work, health care providers and cannabis dispensaries everywhere could use this treatment to help clients in chronic pain.

Approaches like these can supplement more traditional clinical trials to help researchers determine whether these drug classes offer benefit and whether they have comparable or less harm than current treatments. As our society connects to the rich history of healing using these ancient drugs, these proposed changes may offer safer and substantive options for the 50 million Americans living with chronic pain.

Kevin F. Boehnke, PhD, is an Assistant Professor in the Department of Anesthesiology and the Chronic Pain and Fatigue Research Center at the University of Michigan.  He receives funding from the National Institutes of Health, the State of Michigan Veteran Marijuana Research Program, and has received grants from Tryp Therapeutics and Journey Biosciences.

This article originally appeared in The Conversation and is republished with permission.

Not Your Parents’ Pot: Cannabis Is More Potent Now

By Dr. Ty Schepis

Eventually, most adults reach a point where we realize we are out of touch with those much younger than us.

Perhaps it is a pop culture reference that sparks the realization. For me, this moment happened when I was in my late 20s and working with adolescents in school settings to help them quit smoking. When other drugs would occasionally come up, I didn’t understand some of the slang terms they used for these drugs. Many people may have that feeling now when the topic of cannabis comes up – especially in its different and newer forms.

As a professor of psychology, I focus my research on substance use in adolescents and young adults. A major change during my time in research is the legalization and explosion of cannabis availability across the U.S.

There are arguments for and against increasing legalization of cannabis for adult use in the U.S., but expanded access to legal cannabis also may have unintended consequences for adolescents. These consequences are compounded by the increasing potency of some cannabis products.

I use the word “cannabis” since it refers to the plant from which the drugs are derived. It also serves as a catch-all term for any substance with chemical compounds from cannabis plants and addresses concerns that the word marijuana has some long-standing racist overtones.

Cannabis now comes in a larger variety of forms than it used to. When most people over 40 think of cannabis, they imagine its dried form for smoking. This cannabis was not particularly strong: The average THC concentration of cannabis seized by the Drug Enforcement Agency in 1995 was 4%, while it was roughly 15% in 2021.

In addition to the smoked form, some might remember an edible form, often baked into a dessert like a brownie, or hashish, which is derived from more potent parts of the cannabis plant.

Today there are many different cannabis concentrates that have high levels of THC, typically ranging from 40% to 70%, and more than 80% in some cases, depending on the method of extraction. These include oils that can be vaporized by vape or dab pens, waxier substances and even powders.

Differences in Cannabis Products

THC and cannabidiol, or CBD, are the most common chemicals in cannabis. Each one interacts with the brain in different ways, producing different perceived effects.

CBD does not produce the same “high” that THC does, and cannabidiol may have benefits as a medication for severe epilepsy, as well as other potential but as yet unproven medical uses. The differences between THC and CBD come from how they interact with cannabinoid receptors – the proteins onto which these drugs attach – in the brain and body.

However, CBD can also make people sleepy, alter mood in unintended ways and cause stomach upset. Never use a CBD product without consulting a physician.

THC is the chemical most strongly associated with the high from cannabis. By increasing the amount of THC, concentrated products can increase blood levels of THC rapidly and more strongly than nonconcentrates such as traditional smoked cannabis.

Cannabis concentrates also come in many different forms that range from waxy or creamy to hard and brittle. They are made in a variety of ways that may require dry ice, water or flammable solvents such as butane.

The myriad names for cannabis concentrates can be confusing. Concentrate names include “budder,” which refers to a yellowish paste like frosting; “shatter” is made similarly to budder but comes in a thin, brittle and translucent form; there’s also “wax” or “crumble,” which confusingly is not waxy but is more like a powdery or grainy substance; and “keef” or “kief,” which is powdery in nature and derived from the most potent parts of the cannabis plant. It is similar to hashish.

The names change regularly and can vary by guide or from person to person. It is best to ask what a term means from an open and curious place than to act as if you know all the terminology.

Many concentrates are vaporized and inhaled. Vaporizing is different than smoking, as vaporizing heats the concentrate until it becomes a gas, which is inhaled. Smoking involves burning the compound to produce an inhaled gas.

Many who vaporize concentrates call it “dabbing.” This refers to the dab of concentrate to heat, vaporize and inhale. Another way to vaporize cannabis concentrates is to use a vape pen. Vape pens are sometimes also called dab pens, depending on the local terms.

Cannabis and Adolescents

One of the reasons why young people are drawn to these sorts of products is that vaping or dabbing the concentrated form makes it easier to hide cannabis use. Vaping cannabis does not create the typical smell associated with weed.

A 2021 systematic review found that past-year cannabis vaping nearly doubled from 2017 to 2020 in adolescents - jumping from 7.2% to 13.2%. A more recent study in five northeastern U.S. states found that 12.8% of adolescents vaped cannabis in the past 30 days, a more narrow time frame that suggests potential increases in use. In addition, a 2020 study found that one-third of adolescents who vape do so with cannabis concentrates.

Cannabis use by adolescents is scary because it can alter the way their brains develop. Research shows that the brains of adolescents who use cannabis are less primed to change in response to new experiences, which is a key part of adolescent development. Adolescents who use cannabis are also more likely to experience symptoms of schizophrenia, struggle more in school and engage in other risky behaviors.

The risks of cannabis use are even greater with concentrates because of the high levels of THC. This is true for both adolescents and adults, with greater risk for symptoms of schizophrenia such as hallucinations and delusions, mental health symptoms and more severe cannabis use.

The best analogy is with another drug – alcohol. Most people know that a 12-ounce beer is much less potent than 12 ounces of vodka. Cannabis in smoked form is closer to the beer, while a concentrate is more like the vodka. Neither is safe for an adolescent, but one is even more dangerous.

These dangers make early conversations with kids about cannabis and cannabis concentrates critically important. Research consistently shows that expressing disapproval of drug use makes adolescents less likely to start drug use.

Start these conversations early – ideally before middle school. You can find some helpful online resources to guide the conversation.

While these conversations can be uncomfortable, and you can look like the out-of-touch adult, they can be a major step toward preventing adolescents from using cannabis and other drugs.

Ty Schepis, PhD, is a Professor of Clinical Psychology at Texas State University. His research receives funding from the Food and Drug Administration and the National Institute on Drug Abuse.

This article originally appeared in The Conversation and is republished with permission.