Arthritis Foundation Releases First CBD Guideline

By Pat Anson, PNN Editor

The Arthritis Foundation has become the first major patient advocacy group to release guidelines on the use of cannabidiol (CBD) to treat arthritis pain.  

About 54 million Americans have been diagnosed with arthritis. According to a recent national survey, 79 percent of arthritis patients are currently using CBD, have tried it in the past, or are considering it.

CBD infused products – from edibles to lotions to beverages -- are rapidly going mainstream, even though there is little scientific evidence to support their use. There has also been little guidance for consumers on what products to use or in what doses — until now.

“We are intrigued by the potential of CBD to help people find pain relief and are on record urging the FDA to expedite the study and regulation of these products,” the Arthritis Ffoundation said in a statement.

“While currently there is limited scientific evidence about CBD’s ability to help ease arthritis symptoms, and no universal quality standards or regulations exist, we have listened to our constituents and consulted with leading experts to develop these general recommendations for adults who are interested in trying CBD.”  

CBD is largely extracted from a hemp, a marijuana strain that has only trace amounts of THC, the active ingredient that makes people high.

"Millions of people in the U.S. are likely trying to use cannabinoids to treat pain, and many are doing this in ways that might cause more harm than good, especially when they use high doses of THC," said Daniel Clauw, MD, a professor of anesthesiology at the University of Michigan who was one of the experts the foundation consulted.

"It's important that the Arthritis Foundation has taken a stand on CBD,” Clauw said in a statement. “Right now, it appears to be fairly safe and might help certain types of pain. It's far better to give this guidance, even if preliminary, because otherwise people will have no guidance whatsoever." 

DRUG POLICY ALLIANCE

The new guideline is largely cautionary and does not explicitly recommend CBD as a treatment, stating only that it “may help” with arthritis-related symptoms such as pain, insomnia and anxiety.

When taken in moderate doses, experts say CBD has no major safety issues, although it may interact with some drugs commonly taken for arthritis, such as naproxen (Aleve), celecoxib (Celebrex), tramadol (Ultram), gabapentin (Neurontin), pregabalin (Lyrica) and some antidepressants.

The Arthritis Foundation recommends taking CBD in oral sprays or tinctures so the liquid can be taken under the tongue and be absorbed directly into the bloodstream.

Experts say a “go slow” approach is best, starting with a few drops twice a day and increasing the dose gradually over a period of weeks until an effective dose is reached.

The guideline strongly discourages inhaling or vaping CBD because of the risk of respiratory problems. It also discourages taking CBD in edibles, such as gummies and cookies, because the dosing is unreliable. Experts say the effectiveness of topical lotions and creams with CBD is unclear because they often contain other ingredients.

Other key takeaways from the guideline:

• CBD should never be used to replace disease-modifying drugs that help prevent permanent joint damage in inflammatory types of arthritis.

• CBD use should be discussed with your doctor in advance, with follow-up evaluations every three months or so.

• Buy from a reputable CBD company that has each batch tested for purity, potency and safety by an independent laboratory and provides a certificate of analysis.  

Unlike prescription drugs approved by the Food and Drug Administration, the manufacturing process for CBD products is not subject to FDA review, and there has been no FDA evaluation of their effectiveness, proper dosage, how they could interact with drugs, or whether they have side effects. 

The Federal Trade Commission recently warned companies that make CBD products to stop making unsubstantiated claims that cannabidiol can be used to treat arthritis and other chronic pain conditions.

Feds Warn CBD Marketers Again

By Pat Anson, PNN Editor

The Federal Trade Commission (FTC) has warned three companies that sell cannabidiol (CBD) oils, tinctures, edibles and other products to stop making claims that CBD can be used to treat pain and other chronic illnesses.

In letters to the companies, which the FTC is not identifying, the agency warned that it is illegal to advertise that a product can prevent, treat or cure illnesses without scientific evidence to support such claims.

One company’s website claims CBD “works like magic” to relieve “even the most agonizing pain.” Another company advertises CBD as a “miracle pain remedy” for both acute and chronic pain, including pain from cancer treatment and arthritis.

The FTC said the third company’s website promotes CBD gummies as highly effective at treating “the root cause of most major degenerative diseases, including arthritis, heart disease, fibromyalgia, cancer, asthma, and a wide spectrum of autoimmune disorders.” The company also claims its CBD creams and oils can relieve arthritis and fibromyalgia pain.

“In the letters, the FTC urges the companies to review all claims made for their products, including consumer testimonials, to ensure they are supported by competent and reliable scientific evidence,” the agency said in a statement.

The letters also warn that selling CBD products without substantiation could violate the FTC Act and may result in legal action. The companies were given 15 days to respond.

In March 2019, the FTC and Food and Drug Administration sent similar warning letters to three companies -- Nutra Pure, PotNetwork Holdings, and Advanced Spine and Pain — for making false and unsubstantiated health claims about a variety of CBD products.

Nutra Pure, which makes a line of hemp oil, now has a lengthy disclaimer on its website stating that its products “have not been evaluated” by the FDA and that they “are not intended to diagnose, prevent, treat, or cure any disease.”

But when we posed as a customer in an online chat with “Kristen,” a NutraPure representative, we were assured that hemp oil can treat pain.  

Customer: “Do your products help treat pain?”

Kristen: “There are numerous studies showing CBD has the ability to provide therapeutic benefits in the treatment of various conditions, including chronic pain, arthritis, anxiety/depression, nausea, epilepsy, fibromyalgia, glaucoma and many other ailments.”

Customer: “Which one of your products helps treat fibromyalgia?”

Kristen: “We recommend starting with our 300 or 600 mg bottle.”

Customer: “Will that help joint pain?”

Kristen: “They are like an all in one type product.”

Customer: “What does that mean?”

Kristen: “One product helps with all types of conditions.”

Customer: “Including pain?”

Kristen: “Yes.”

CBD is a non-psychoactive chemical compound derived from the cannabis plant. Much of it comes from hemp – a less potent strain of marijuana – that was legalized under the 2018 Farm Bill. There are literally thousands of CBD products on the market being sold online and over-the-counter without a prescription, often with dubious claims about their health benefits.

FDA and FTC enforcement actions against CBD marketers are sporadic and have usually only targeted small companies. But an FDA warning letter in July to Curaleaf, a Massachusetts company that sells CBD products nationwide, had an immediate impact on one large retailer. CVS Pharmacy pulled most Curaleaf products from its stores.

Study: Cannabis Flowers Rich in THC More Effective for Pain Relief

By Pat Anson, PNN Editor

Another study by researchers at the University of New Mexico suggests that tetrahydrocannabinol (THC) -- the psychoactive ingredient in marijuana – should not be ignored as a treatment for chronic pain.

In an unconventional survey of nearly 3,000 cannabis users, researchers found that those who used whole cannabis flowers or buds rich in THC reduced their pain levels an average of three points on a 0 to 10 pain score. Those who ingested cannabidiol (CBD) did not experience similar pain relief.

The researchers relied on information collected from the Releaf App, a mobile software program they created that allows cannabis users to self-report their experiences using different cannabis products, including flowers, edibles, tinctures and ointments.. Their findings are published in the journal Complementary Therapies in Medicine.

"Perhaps the most surprising result is just how widespread relief was with symptom relief reported in about 95 percent of cannabis administration sessions and across a wide variety of different types of pain," said Xiaoxue Li, PhD, an assistant professor of economics at UNM.

"Cannabis likely has numerous constituents that possess analgesic properties beyond THC, including terpenes and flavonoids, which likely act synergistically for people that use whole dried cannabis flower," added Jacob Miguel Vigil, PhD, a professor in UNM’s Department of Psychology. "Cannabis offers the average patient an effective alternative to using opioids for general use in the treatment of pain with very minimal negative side effects for most people."

The authors caution that cannabis use does carry the risk of addiction and short-term impairment in cognitive and behavioral functioning.

“Cannabis with high THC also causes mood elevation and adjusts attentional demands, likely distracting patients from the aversive sensations that people refer to (as) pain," explains Vigil.

Previous studies using data from the Releaf app found that cannabis also provides relief from insomnia, seizures, depression, anxiety and fatigue. Despite conventional wisdom, THC was found to be more important than CBD in generating therapeutic benefits.

A significant weakness of the app is that it relies on cannabis users to subjectively self-report their experiences outside of a clinical setting. There is also no way to measure the quality or quantity of the cannabis they are ingesting.   

Two-Thirds of Americans Accept Cannabis as Pain Treatment   

Another new survey – conducted by the American Society of Anesthesiologists (ASA) – found wide acceptance of cannabis as a possible treatment for pain. The online survey 1,005 adults was conducted earlier this month.

More than two-thirds of those surveyed said they have used or would consider using cannabis to manage pain. Nearly three-quarters of millennials fall in that category. Two-thirds of Gen Xers and baby boomers expressed interest in cannabis, with 25% of Gen Xers and 18% of baby boomers saying they have used cannabis for pain.

Most of those who expressed interest in using cannabis products believe they are safer or have fewer side effects than opioids or other medications.

Other key findings:

• 57% believe more cannabis research is needed

• 34% don't feel a need to discuss cannabis use with their doctor

• 13% believe no other type of pain management works for them

• 40% wrongly believe CBD products sold at grocery stores, truck stops, health food stores and dispensaries are approved by the FDA.

The ASA recently endorsed two bills that seek to expand research on CBD and marijuana: the Medical Cannabis Research Act and the Cannabidiol and Marihuana Research Expansion Act. The bipartisan bills would increase the number of manufacturers allowed to grow cannabis for research purposes and streamline the application process.

“As experts in managing pain, physician anesthesiologists are concerned about the lack of research regarding the safety and effectiveness of marijuana and cannabinoids," said ASA President Linda Mason, MD.

Government Grown Cannabis May Be Harming Research

By Roger Chriss, PNN Columnist

Physician researcher Sue Sisley, MD, has filed suit against the federal government over the quality of cannabis provided for her study on post-traumatic stress disorder. Sisley claims that the cannabis supplied by the DEA-sanctioned facility at the University of Mississippi is “suboptimal.”

Sisley told Green Entrepreneur that the DEA provided "standardized green powder that is just cannabis ground up.” She also said that the plants were moldy and contained sticks and seeds. 

Sisley is not the first researcher to say government cannabis intended for research is not the same as the cannabis available in dispensaries. This of course poses a key question: What is research cannabis?

Cannabis is a plant. Specifically, cannabis is the genus of a plant that includes the species C. sativa, C. indica, and C. ruderalis. There is still dispute if C. ruderalis should be included with C. sativa, or if all three species should be considered a single species, C. sativa. 

There is no precise pharmacological definition of medical cannabis. There is no agreed-upon level of THC, CBD, or other cannabinoids, and no accepted terpene profile. In dispensaries, cannabis comes in a large variety of strains used in a wide range of products. 

There is poor consistency among strains. Leafly recently attempted to measure the reliability of cannabis strains and found that even the most reliable ones were far from consistent at the levels necessary for clinical research.

Moreover, cannabis is a moving target. Because it is a commercial product often intended for nonmedical use, it is subject to a variety of market forces involving its various psychogenic effects. And new strains are introduced regularly. 

Further, cannabis products are consumed in many different ways, such as smoking, vaporizing, ingesting and through the skin . The bioavailability of cannabis varies significantly by route of consumption because of different absorption levels and metabolism. So whatever research cannabis is used would have to be specified by strain, amount and route of administration. 

For research purposes, that requires precise information. But as Genetic Engineering & Biotechnology News reported, medical cannabis comes in so many forms and has so many different uses that it presents a "unique challenge to cannabis testing laboratories." No existing test provides a good model on how to proceed.

In other words, there is no clear definition of research cannabis and there is no practical way to reliably test commercial strains with a consistency adequate for clinical studies. 

This means the definition of research cannabis is arbitrary. Researchers and advocates keep adjusting the definition or questioning the quality to explain away poor outcomes. According to Microscopes and Machines, when Dr. Sisley's PTSD study concluded, she unblinded the data and quickly came to realize the quality of cannabis provided by the University of Mississippi "had negatively affected the study’s efficacy data.”

But we cannot define research cannabis as the form of cannabis that only gives the results we were hoping for. This would be circular and self-justifying. It would also be self-defeating since we’d never know what, if anything, cannabis has to offer. 

Cannabis is a plant, not a laboratory-synthesized chemical being turned into a USP-grade pharmaceutical. As Jonathan Stea wrote in Scientific American,“it is best to conceptualize cannabis as a chemical soup with over 500 ingredients that can be served in countless different ways.”

This means that researchers will need to define their cannabis before starting a study. And the U.S. government will need to provide such cannabis. Fortunately, the National Institutes of Health is responding by producing more varieties of cannabis.

A more favorable legal landscape would also help. There may not be any “research cannabis” per se, but cannabis is certainly worth researching. 

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Marijuana Use May Affect Patient Anesthesia

By Kata Ruder, Kaiser Health News

When Colorado legalized marijuana, it became a pioneer in creating new policies to deal with the drug.

Now the state’s surgeons, nurses and anesthesiologists are becoming pioneers of a different sort in understanding what weed may do to patients who go under the knife.

Their observations and initial research show that marijuana use may affect patients’ responses to anesthesia on the operating table — and, depending on the patient’s history of using the drug, either help or hinder their symptoms afterward in the recovery room.

Colorado makes for an interesting laboratory. Since the state legalized marijuana for medicine in 2000 and allowed for its recreational sale in 2014, more Coloradans are using it — and they may also be more willing to tell their doctors about it.

Roughly 17% of Coloradans said they used marijuana in the previous 30 days in 2017, according to the National Survey on Drug Use and Health, more than double the 8% who reported doing so in 2006. By comparison, just 9% of U.S. residents said they used marijuana in 2017.

“It has been destigmatized here in Colorado,” said Dr. Andrew Monte, an associate professor of emergency medicine and medical toxicology at the University of Colorado School of Medicine and UCHealth. “We’re ahead of the game in terms of our ability to talk to patients about it. We’re also ahead of the game in identifying complications associated with use.”

One small study of Colorado patients published in May found marijuana users required more than triple the amount of one common sedation medicine, propofol, as did nonusers.

Those findings and anecdotal reports are prompting additional questions from the study’s author, Dr. Mark Twardowski, and others in the state’s medical field: If pot users indeed need more anesthesia, are there increased risks for breathing problems during minor procedures?

Are there higher costs with the use of more medication, if a second or third bottle of anesthesia must be routinely opened? And what does regular cannabis use mean for recovery post-surgery?

But much is still unknown about marijuana’s impact on patients because it remains illegal on the federal level, making studies difficult to fund or undertake.

It’s even difficult to quantify how many of the estimated 800,000 to 1 million anesthesia procedures that are performed in Colorado each year involve marijuana users, according to Dr. Joy Hawkins, a professor of anesthesiology at the University of Colorado School of Medicine and president of the Colorado Society of Anesthesiologists. The Colorado Hospital Association said it doesn’t track anesthesia needs or costs specific to marijuana users.

As more states legalize cannabis to varying degrees, discussions about the drug are happening elsewhere, too. On a national level, the American Association of Nurse Anesthetists recently updated its clinical guidelines to highlight potential risks for and needs of marijuana users. American Society of Anesthesiologists spokeswoman Theresa Hill said that the use of marijuana in managing pain is a topic under discussion but that more research is needed. This year, it endorsed a federal bill calling for fewer regulatory barriers on marijuana research.

Should Patients Disclose Marijuana Use? 

No matter where patients live, though, many nurses and doctors from around the country agree: Patients should disclose marijuana use before any surgery or procedure. Linda Stone, a certified registered nurse anesthetist in Raleigh, N.C., acknowledged that patients in states where marijuana is illegal might be more hesitant.

“We really don’t want patients to feel like there’s stigma. They really do need to divulge that information,” Stone said. “We are just trying to make sure that we provide the safest care.”

In Colorado, Hawkins said, anesthesiologists have noticed that patients who use marijuana are more tolerant of some common anesthesia drugs, such as propofol, which helps people fall asleep during general anesthesia or stay relaxed during conscious “twilight” sedation. But higher doses can increase potentially serious side effects such as low blood pressure and depressed heart function.

Limited airway flow is another issue for people who smoke marijuana. “It acts very much like cigarettes, so it makes your airway irritated,” she said.

To be sure, anesthesia must be adjusted to accommodate patients of all sorts, apart from cannabis use. Anesthesiologists are prepared to adapt and make procedures safe for all patients, Hawkins said. And in some emergency surgeries, patients might not be in a position to disclose their cannabis use ahead of time.

Even when they do, a big challenge for medical professionals is gauging the amounts of marijuana consumed, as the potency varies widely from one joint to the next or when ingested through marijuana edibles. And levels of THC, the chemical with psychoactive effects in marijuana, have been increasing in the past few decades.

“For marijuana, it’s a bit of the Wild West,” Hawkins said. “We just don’t know what’s in these products that they’re using.”

Marijuana’s Effects On Pain After Surgery

Colorado health providers are also observing how marijuana changes patients’ symptoms after they leave the operating suite — particularly relevant amid the ongoing opioid epidemic.

“We’ve been hearing reports about patients using cannabis, instead of opioids, to treat their postoperative pain,” said Dr. Mark Steven Wallace, chair of the pain medicine division in the anesthesiology department at the University of California-San Diego, in a state that also has legalized marijuana. “I have a lot of patients who say they prefer it.”

Matthew Sheahan, 25, of Denver, said he used marijuana to relieve pain after the removal of his wisdom teeth four years ago. After surgery, he smoked marijuana rather than using the ibuprofen prescribed but didn’t disclose this to his doctor because pot was illegal in Ohio, where he had the procedure. He said his doctor told him his swelling was greatly reduced. “I didn’t experience the pain that I thought I would,” Sheahan said.

In a study underway, Wallace is working with patients who’ve recently had surgery for joint replacement to see whether marijuana can be used to treat pain and reduce the need for opioids.

But this may be a Catch-22 for regular marijuana users. They reported feeling greater pain and consumed more opioids in the hospital after vehicle crash injuries compared with nonusers, according to a study published last year in the journal Patient Safety in Surgery.

“The hypothesis is that chronic marijuana users develop a tolerance to pain medications, and since they do not receive marijuana while in the hospital, they require a higher replacement dose of opioids,” said Dr. David Bar-Or, who directs trauma research at Swedish Medical Center in Englewood, Colo., and several other hospitals in Colorado, Texas, Missouri and Kansas. He is studying a synthetic form of THC called dronabinol as a potential substitute for opioids in the hospital.

Again, much more research is needed.

“We know very little about marijuana because we’ve not been allowed to study it in the way we study any other drug,” Hawkins said. “We’re all wishing we had a little more data to rely on.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Medical Cannabis Won’t Solve the Opioid Crisis

By Roger Chriss, PNN Columnist

Medical cannabis legalization isn’t helping reduce opioid overdoses. Two major studies have closely examined over a decade’s worth of data, finding no support for the idea that legalizing medical cannabis reduces prescription opioid use, overdose or mortality.

In June, Stanford researchers led by Chelsea Shover, PhD, published a study in PNAS using the same methodology as a 2014 JAMA study that found a positive association between cannabis legalization and lower opioid mortality from 1999 to 2010. But Shover and colleagues included more recent data and states with legalized medical cannabis.

“Our expanded analysis does not support the interpretation that broader access to cannabis is associated with lower opioid overdose mortality,” they concluded.

The 2014 study was very cautious in its findings, but cannabis advocates and industry representatives used it to support legalization efforts.

“It’s become such a pervasive idea,” Shover told STAT News. “It would be amazing if it was this simple, but the evidence is telling us now that it’s not.”

Early this month, Columbia University’s Mailman School of Public Health published a new study in JAMA Network Open that looked at whether people use cannabis in place of prescription opioids.  Researchers looked at data from 627,000 people aged 12 years and older who took the National Survey on Drug Use and Health from 2004 to 2014.

The results showed that enactment of medical marijuana laws was not associated with a reduction in prescription opioid abuse, contradicting the hypothesis that people would substitute marijuana for prescription opioids.

“We tested this relationship and found no evidence that the passage of medical marijuana laws — even in states with dispensaries — was associated with a decrease in individual opioid use of prescription opioids for nonmedical purposes," said senior author Silvia Martins, MD, PhD, an associate professor of epidemiology at Columbia.

The Shover-PNAS study also made the important point that medical cannabis users comprise only about 2.5% of the U.S. population. The vast majority of cannabis use is recreational. The Washington State Liquor Control and Cannabis Board estimates that only about 20% of so-called medical users are really using cannabis for medical reasons.

In other words, there aren’t enough medical cannabis users to impact nationwide overdose trends. And in state-level analysis, there is no evidence of any substantial effect, positive or negative, from medical cannabis legalization.

There are concerns that cannabis could actually make the opioid crisis worse. A 2018 study published in the American Journal of Psychiatry found that “cannabis use appears to increase rather than decrease the risk of developing nonmedical prescription opioid use and opioid use disorder.”

“Scientific evidence does not support claims that marijuana helps people kick opioids.”

— Dr. Nora Volkow, NIDA Director

"My main concern is by basically misinforming potential patients about the supposedly beneficial effects of cannabis, they may forgo a treatment that is lifesaving," NIDA director Nora Volkow, MD, told USA Today. “Scientific evidence does not support claims that marijuana helps people kick opioids.”

The FDA is taking note, warning a large cannabis operator last week to stop making unsubstantiated claims that its products can treat chronic pain, cancer, opioid withdrawal and other medical conditions.

Medical cannabis has uses, of course, but taking it for conditions it is not proven to help may lead to harms. Perhaps a way can be found to incorporate cannabis in addiction treatment, but that is quite different from expecting medical cannabis legalization to be an exit ramp for the opioid crisis.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Warns Curaleaf About Marketing of CBD Products

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is warning a large cannabis company to stop making unsubstantiated claims that its products can treat chronic pain, cancer, opioid withdrawal and other medical conditions.

An FDA warning letter was sent to Curaleaf, a Massachusetts-based company that sells cannabidiol (CBD) products online and in stores, and operates dispensaries in a dozen states. CVS Health responded to the FDA letter by pulling some Curaleaf products off its store shelves.

“Selling unapproved products with unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases and conditions — can put patients and consumers at risk by leading them to put off important medical care. Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD,” acting FDA Commissioner Ned Sharpless, MD, said in a statement. “Consumers should beware of purchasing or using any such products.”

Curaleaf, which claims to be the largest cannabis operator in the United States, makes an extensive line of CBD lotions, creams, oils and skin patches.

It recently began marketing a line of CBD products for pets to treat pain, spasms, anxiety and inflammation in animals.

The FDA’s warning letter to Curaleaf cited a number of unapproved marketing claims made by the company online and in social media, including:

• “CBD was effective in killing human breast cancer cells.”

• “CBD has been linked to the effective treatment of Alzheimer’s disease…”

• “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”

• “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”

• “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety … ADHD.”

The FDA gave Curaleaf 15 working days to respond. Failure to correct the violations could result in legal action, including seizure of the company’s products.

“Curaleaf is committed to the highest standards of quality and compliance, and will work collaboratively with the FDA to resolve all issues addressed in the agency's letter,” the company said in a statement.

“Compliance is a top priority for Curaleaf and the Company is fully committed to complying with FDA requirements for all of the products that it markets. We can affirm that nothing in the letter raises any issues concerning the quality and consistency of any Curaleaf product or calls into question the high safety standards of the Company's cultivation and manufacturing processes.”

CBD Products Loosely Regulated

Unlike prescription drugs approved by the FDA, the manufacturing process for CBD products is not subject to FDA review, and there has been no FDA evaluation of their effectiveness, proper dosage, how they could interact with drugs, or whether they have side effects.

Despite the lack of regulatory oversight, there has been explosive growth for CBD companies and their products are starting to appear in mainstream stores. In March, CVS Pharmacy and Walgreens started selling CBD lotions, tinctures, edibles and lozenges — including some made by Curaleaf.

“The only Curaleaf products we are selling are its CBD lotion and CBD transdermal patches,” CVS said in a statement. “Following the FDA’s warning letter to Curaleaf, we will be removing these items from our CBD offering.”  

The FDA sent similar warning letters to three cannabis operators in April. Until now, the enforcement actions have been sporadic and only targeted small companies.

“We will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law through actions like those the FDA is taking today. At the same time, we also recognize the potential opportunities and significant interest in drug and other consumer products containing CBD,” said FDA Principal Deputy Commissioner Amy Abernethy, MD.

“We understand this is an important national issue with public health impact and of interest to American hemp farmers and many other stakeholders. The agency has a well-established pathway for drug development and drug approvals, and we remain committed to evaluating the agency’s regulatory policies related to other types of CBD products.”

The FDA held a public hearing on the issue in May, and opened a docket for public comments to obtain scientific data about the safety, manufacturing, quality, marketing, labeling and sale of CBD products. Nearly 4,500 comments were received. The agency plans to report on its progress this fall.

This week Curaleaf announced it will acquire GR Companies, a large cannabis retailer, in a cash and stock deal valued at $875 million. Curaleaf said the purchase solidifies it’s position as “the world's largest cannabis company by revenue and the largest in the U.S. across key operating metrics.”

The Future of CBD

By Roger Chriss, PNN Columnist

Is CBD a medical miracle or just another over-hyped health fad? The cannabinoid known as cannabidiol (CBD) is appearing in hundreds of foods, drinks and health products – even though we know little about its potential harms and benefits. Recent research runs the gamut, suggesting that CBD can fight superbug infections or cause liver damage.

A review of 35 clinical studies found CBD effective in treating anxiety and epilepsy, but there was no evidence it works for diabetes, Crohn's disease, ocular hypertension, fatty liver disease or chronic pain.

But there may be some untapped possibilities. Ingenious bench science and clinical research is improving our understanding of how CBD acts in the body, which is leading to new drugs with impressive potential for treating serious illnesses.

How Does CBD Work?

In simple terms, no one knows. CBD doesn’t seem to act directly on the cannabinoid receptors CB1 and CB2, although it does have some activity in serotonin 5HT1A, GRP55, and TRPV1 receptors that regulate anxiety, inflammation and pain sensation.  

Although none of these receptors is directly involved in seizures, CBD is being used successfully to treat epilepsy and other seizure disorders. CBD in the highly-purified form Epidiolex is FDA-approved as “add-on therapy” for Dravet syndrome and Lennox-Gastaut syndrome, two rare childhood seizure disorders.

New pharmacological research suggests that CBD may reduce seizure frequency through a “drug-drug interaction” rather than as an anti-seizure medication in and of itself.

In other words, whatever CBD is doing probably involves a host of small nudges often described as endocannabinoid activity. This makes for a complex set of interactions and contraindications, many still not well understood.  

New Drugs Derived from CBD

CBD acts on too many receptors in too many ways to make for predictable clinical effects. And at high doses CBD is potentially toxic to both the liver and nerves over the long term. But understanding this activity is helping guide research.

A potent CBD-derived compound called KLS-13019 has a more targeted effect on receptors and is being studied as a treatment for some neurological conditions.

Even more promising is EHP-101, an oral formulation of a synthetic CBD molecule that helped repair myelin around damaged nerve fibers in mice. This is an exciting if preliminary finding that may have potential for treating multiple sclerosis (MS). Emerald Health Therapeutics is planning to launch a Phase II clinical trial of EHP-101 in MS patients by the end of the year.

“Restoring the myelin sheath around nerves, or remyelination, would be considered a ‘Holy Grail’ outcome in the treatment of MS,” Jim DeMesa, MD, CEO of Emerald Health Pharmaceuticals, said in a statement. “These preclinical data provide the first evidence of remyelination with our lead clinical-stage drug product candidate and provide promising evidence for the possibility to treat, and potentially reverse, several forms of MS in the future.”

CBD itself may have uses as a wellness product for otherwise healthy people. It is certainly an appealing indulgence. But CBD-derived products that avoid the complications of CBD while taking advantage of specific activity learned from studying CBD are showing great promise.

New drugs replace old drugs all the time. Aspirin was outclassed by ibuprofen and naproxen, barbiturates by benzodiazepines, and MAO inhibitors by TCAs and more recently SSRIs. CBD may fade as a pharmaceutical, but its descendants could be the wonder drugs that CBD is often touted as.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Cannabis Effective in Treating Fibromyalgia

By Pat Anson, PNN Editor

Cannabis significantly reduces pain and improves quality of life for patients with fibromyalgia, according to Israeli researchers who conducted one of the first studies to look at the effectiveness of cannabis in treating fibromyalgia.

Nearly 300 patients diagnosed with fibromyalgia completed the 6-month study at a Tel Aviv clinic. Participants suffered from fibromyalgia symptoms for a median length of seven years and nine out of ten reported constant daily pain. Fibromyalgia is characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. Standard treatments for fibromyalgia often prove to be ineffective.

"It is commonly accepted that chronic pain can be treated with cannabis, but there is scarce evidence to support the role of medical cannabis in the treatment of fibromyalgia specifically," says Lihi Bar-Lev Schleider, head research scientist at Tikun Olam, a cannabis producer that sponsored the study.

Patents began with a low dose of cannabis every 3-4 hours that was gradually increased until it had a therapeutic effect.

Participants were treated with two Tikun Olam strains of cannabis; the high-THC “Alaska” strain and the high-CBD “Avidekel” strain, which has virtually no THC.  Both strains are available as a tincture, topical oil or for use in a vaporizer.

Over 80 percent of the patients reported at least moderate improvement in their pain. At the start of the study, the median pain level for patients on a 1 to 10 scale was 9, but after six months the median pain level was reduced to 5.

In addition to lower pain intensity, nearly 93 percent of patients said they slept better and about 80 percent said there was improvement in their depression. Nearly two-thirds said their quality of life was good or very good. Appetite and sexual activity also improved.

The most common side effects were relatively minor, including dizziness, dry mouth and gastrointestinal symptoms.

“Our data indicates that medical cannabis could be a promising therapeutic option for the treatment of fibromyalgia, especially for those who failed on standard pharmacological therapies. We show that medical cannabis is effective and safe when titrated slowly and gradually,” researchers reported in the Journal of Clinical Medicine.

“Considering the low rates of addiction and serious adverse effects (especially compared to opioids), cannabis therapy should be considered to ease the symptom burden among those fibromyalgia patients who are not responding to standard care.”

During the study, about one out of five patients either stopped or reduced their use of opioid pain medication or benzodiazepines while taking cannabis.

Medical marijuana has been legal in Israel since the early 1990s. A recent survey found about 27 percent of Israeli adults have used cannabis in the past year, one of the highest rates in the world.

Is CBD Psychoactive?

By Roger Chriss, PNN Columnist

The CBD boom is making Dutch Tulip Mania seem dull. CBD water is becoming a thing, and Ben & Jerry’s may soon introduce a CBD-infused ice cream. Basically, CBD is in everything.

The boom is built on the assumption that CBD, the cannabis cannabinoid known as cannabidiol, is not psychoactive. The FDA isn’t so sure and the DEA demurs, putting the CBD-based seizure drug Epidiolex into Schedule V last year.

So is CBD psychoactive? The answer hinges on the definition of the term psychoactive.

According to the World Health Organization: "Psychoactive substances are substances that, when taken in or administered into one's system, affect mental processes, e.g. cognition or affect.”

The National Institute on Drug Abuse explains psychoactive drugs this way: “Drugs in this category act on the central nervous system and alter its normal, everyday activity, causing changes in mood, awareness, and behavior.”

The term “psychotropic” is used with a similar meaning. MedicineNet states that a psychotropic drug is “any drug capable of affecting the mind, emotions, and behavior.”

But does CBD affect mental states, alter everyday activity, or change mood, awareness, or behavior?

The FDA last year approved Epidiolex -- the first CBD-based medication -- for the treatment of two rare and severe forms of childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. CBD potentially has many other uses, including neurological conditions such as Alzheimer’s and dementia, and neuropsychiatric illness such as autism, ADHD, and PTSD.  It could also be beneficial for anorexia, anxiety, and mood disorders.

Purveyors of commercial CBD products go further, claiming that CBD may help with insomnia, social anxiety, and panic attacks. Although most product labels avoid specific claims of treatment efficacy to avoid FDA scrutiny, clear statements of possible benefits are easy to find online.

The FDA recently sent a warning letter to a New Jersey company for claiming that CBD can treat anxiety, depression, PTSD, schizophrenia, psychosis and obsessive compulsive disorder.

In order for CBD to do even half of this, it would have to have an effect on mental states, mood and awareness. In other words, CBD could not do what its proponents claim without being psychoactive, at least in the narrow, technical sense of the term.

Dose Matters

But details matter here. First, psychoactive does not mean intoxicating, hallucinogenic or dissociative. And many prescription drugs have benefits precisely because they are psychoactive. Even caffeine is arguably psychoactive, though only very weakly.

Second, dose matters. The pharmaceutical Epidiolex is administered in doses that have 10 to 100 times more CBD than a typical over-the-counter or commercial CBD product. So CBD may be psychoactive in therapeutic doses, but not in “commercial” doses. Of course, this assumes the product actually contains CBD, which in practice is not necessarily the case.

Third, route of administration matters. CBD is only weakly bioavailable and unstable in light or temperature extremes. A clear bottle of CBD water or CBD bath oil could easily lose much of the CBD it may contain, and the remaining CBD may not even be absorbed. And if the CBD is applied to non-vascularized tissue, as is the case with CBD mascara, then it cannot be psychoactive because of a lack of blood vessels for transport to the brain.

Thus, whether or not CBD is psychoactive depends on the amount and method that CBD is introduced to the human body. Since most of the claims from proponents remain unverified and in many cases untested even in animals, it could be premature to state that CBD is psychoactive in a specific way.

On the other hand, the existing work on CBD argues for calling CBD psychoactive. Recent findings by Yasmin Hurd showed that CBD, specifically Epidiolex, reduces cravings in people addicted to heroin. Ongoing research is demonstrating possible benefits of CBD for seizure disorders in humans and even in dogs.

Project CBD noted in 2016 that “as our scientific understanding and therapeutic experience deepens, the description of CBD as non-psychoactive may fall by the wayside.”

For now, it would be reasonable to say that CBD is probably “weakly psychoactive” at commercial doses but more “strongly psychoactive” at therapeutic doses. As more studies are completed on what CBD actually does, the pharmacological description of CBD can be updated accordingly.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

House Panel Seeks Clinical Trials of Kratom

By Pat Anson, PNN Editor

At a time when several states and cities have banned kratom, a powerful congressional committee is recommending that the herbal supplement be studied in clinical trials because of its “potential promising results” in treating chronic pain.

In a report to Congress, the House Appropriations Committee recommends that the National Institutes of Health (NIH) conduct research on whether kratom can be used as an alternative to opioids in treating pain.

“The Committee requests that NIH expand research on all health impacts of kratom, including its constituent compounds, mitragynine, and 7-hydroxymitragynine. The Committee is aware of the potential promising results of kratom for acute and chronic pain patients who seek safer alternatives to sometimes dangerously addictive and potentially deadly prescription opioids.”

The committee also recommended that the Agency for Healthcare Research and Quality (AHRQ) spend $3 million on clinical trials of kratom and cannabidiol (CBD) as alternatives for treating pain, and that the trials be conducted in “geographic regions hardest hit by the opioids crisis.”

The panel said it was concerned that the continuing classification of cannabis as a Schedule I controlled substance was stifling research “at a time when we need as much information as possible about these drugs.”

“The Committee notes that little research has been done to date on natural products that are used by many to treat pain in place of opioids. These natural plants and substances include kratom and cannabidiol (CBD). Given the wide availability and increased use of these substances, it is imperative to know more about potential risks or benefits, and whether or not they can have a role in finding new and effective non-opioid methods to treat pain.”

The committee said the current state of pain management in the U.S. is “often inadequate for many patients” and that additional treatments were needed. It asked that Congress be given an update on the development of non-opioid chronic pain therapies in the next fiscal year.

To be clear, the 346-page report by the House committee is an ambitious “wish list” of hundreds of various projects that may or may not be included in a final congressional spending bill.  But the inclusion of funding for kratom research is significant, given the campaign against kratom by some public health offiicials.

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years millions of Americans have discovered kratom and use it as a daily treatment for pain, addiction, depression and anxiety.  

Although kratom is not an opioid, health officials have warned that it has “opioid-like” qualities, can be addictive and is not approved for any medical condition. Last month the CDC said kratom was listed as the cause of death in at least 91 overdoses and the FDA said it discovered dangerous levels of heavy metals in dozens of kratom products.

Kratom has been banned in 6 states and dozens of counties and cities have enacted or are considering their own bans. Last year, the Department of Health and Human Services (HHS) recommended to the DEA that kratom be classified as a Schedule I substance – which would effectively ban it nationwide.

Ironically, HHS oversees both the NIH and AHRQ, the same agencies the House Appropriations Committee wants to fund for kratom research.   

Using Cannabis and Opioids Together May Not Be Such a Great Idea

By Roger Chriss, PNN Columnist

The opioid-sparing effect of cannabis is routinely touted as a reason for marijuana legalization. The hope is that cannabis combined with opioid medication will produce equal analgesia at lower opioid doses, thus reducing the risks associated with opioid therapy.

But evidence in favor of the opioid-sparing effect is largely pre-clinical and often involves animals or healthy volunteers, not the real world conditions that pain patients live with.

A recent study on rhesus monkeys, for example, at the University of Texas found that combining cannabinoids with morphine did not significantly increase the impulsivity or memory impairment of the monkeys.

A 2018 study by Ziva Cooper and colleagues on healthy cannabis smokers concluded that cannabis enhances the analgesic effect of oxycodone, suggesting there is a synergy between the two.

And a 2017 systematic review of over two dozen studies in the journal Neuropsychopharmacology reported “robust evidence of the opioid-sparing effect of cannabinoids.”

But evidence against the opioid-sparing effect of cannabis is mounting, based on clinical findings in real-world chronic pain patients.

Andrew Rogers of the University of Houston reported at the 2019 American Pain Society Scientific Meeting that chronic pain patients who used both prescription opioids and recreational marijuana showed higher levels of anxiety, depression and substance abuse problems than those who used opioids alone. There was no difference between the two groups in pain levels.

"The things psychologists would be most worried about were worse, but the thing patients were using the cannabis to hopefully help with — namely pain — was no different,” Rogers told MedPageToday. "Co-use of substances generally leads to worse outcomes. As you pour on more substances to regulate anxiety and depression, symptoms can go up."

A large Australian study in The Lancet Public Health found that cannabis use was common in patients with chronic non-cancer pain who were prescribed opioids, but “there was no evidence that cannabis use reduced pain severity or interference or exerted an opioid-sparing effect.”

This research, known as the Australia POINT study, followed over 1,500 chronic pain patients for almost four years. Although its methodology has limitations, it is one of the largest long-term studies of opioids and cannabis under real-world conditions.

“At each assessment, participants who were using cannabis reported greater pain and anxiety, were coping less well with their pain, and reported that pain was interfering more in their life, compared to those not using cannabis,” said lead author Gabrielle Campbell, PhD, of the University of New South Wales.

In other words, the opioid-sparing effect of cannabis seems not to work well in the real world, despite its apparent success under laboratory conditions. There are several possible factors at work.

First, laboratory conditions are artificial. Studies often use lab animals or healthy human volunteers. But people with chronic health conditions may be different. Or perhaps people who are experienced with cannabis and willing to spend a day in a laboratory being subjected to painful stimuli are different.

Second, laboratory studies are often short term, but chronic pain is long term. The cumulative risks of opioids and cannabis, as well as the complex interactions between them, may take time to unfold and discover. It is possible that an initial opioid-sparing benefit washes away quickly and is replaced by nontrivial risks.

Third, real-world studies emphasize patient outcomes, a factor that laboratory work cannot assess. Because outcomes are so important, studies that focus on them must be given greater weight. 

More research will be needed to sort out the effects of combining cannabis and opioids in chronic pain management. But at present, clinical studies point to more risks and harms than benefits. Perhaps a subset of patients or a particular combination of a specific opioid and cannabis preparation will change this. Or perhaps combining cannabis and opioids is not such a great idea. 

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Feds Warn CBD Marketers About False Medical Claims

By Pat Anson, PNN Editor.

The Food and Drug Administration and the Federal Trade Commission are tapping the brakes on the fast growing market for cannabidiol (CBD), warning companies not to make false claims that CBD products can be used to treat fibromyalgia, migraine, arthritis and other chronic illnesses.

The agencies sent warning letters to three companies — Nutra Pure, PotNetwork Holdings, and Advanced Spine and Pain — for making false and unsubstantiated health claims about a variety of CBD oils, extracts and edibles.

The FDA and FTC sent the warning letters on March 28 and gave the companies 15 days to respond.

Nutra Pure’s website, according to regulators, claimed that “CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders.”

Claims were also made that CBD is “an effective and safe treatment alternative” for inflammatory conditions such as lupus, Celiac disease and rheumatoid arthritis.

Nutra Pure, which makes a line of hemp oil, has a small disclaimer on its website stating that “these products are not intended to diagnose, prevent, treat, or cure any disease.”

NUTRA PURE IMAGE

PotNetwork has a similar disclaimer on its website, where it sells everything from CBD infused gummy bears and energy drinks to moisturizers and pet care products. According to the FDA, the company falsely claimed that CBD “blocked the progression of arthritis” and “has also shown the ability to kill cancer cells directly.”  

In addition to marketing CBD products, Advanced Spine and Pain also offers stem cell therapy, steroid injections, trigger point injections and ketamine infusions at its “Relievus” clinics in New Jersey and Pennsylvania.

‘Open Questions’ About CBD Safety

The federal crackdown on CBD marketing comes at a time when CBD products are starting to appear in mainstream stores. CVS Pharmacy and Walgreens started selling cannabis-based lotions, tinctures, edibles and lozenges in stores last month. The CBD products are being sold over-the-counter and without a prescription.  

The FDA and FTC announced no actions against CVS, Walgreens or other retailers selling CBD products, but they sent a clear message that the marketing of CBD will be closely watched.

“We treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that’s marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it may be introduced into interstate commerce,” FDA commissioner Scott Gottlieb, MD, said in a statement. “Additionally, it is unlawful to introduce food containing added CBD, or the psychoactive compound THC, into interstate commerce, or to market CBD or THC products as dietary supplements.”

The 2018 Farm Bill removed hemp – a less potent strain of marijuana – from the Controlled Substances Act. That made hemp products legal to sell, but left the FDA in charge of regulating dietary supplements containing CBD. The agency is still trying to figure out how to regulate a product for which there is growing consumer demand, but little scientific evidence to support its use.

“While the availability of CBD products in particular has increased dramatically in recent years, open questions remain regarding the safety considerations raised by their widespread use,” Gottlieb said. “There are also unresolved questions regarding the cumulative exposure to CBD if people access it across a broad range of consumer products, as well as questions regarding the intended functionality of CBD in such products.”

Gottlieb has announced plans to hold a public hearing on May 31 to review the safety and effectiveness of CBD products. The FDA is also forming an internal working group within the agency to explore what regulatory changes would be needed for CBD products to be marketed legally.  

CVS Begins Selling Cannabis Products

By Pat Anson, PNN Editor

You may not be able to get your opioid prescription filled at a CVS pharmacy, but you can stock up on medical marijuana. The nation’s largest drug store chain has begun selling cannabis-based products in eight states, despite lingering concerns about their effectiveness and legal status.

The move was announced by cannabis retailer Curaleaf Holdings, which carries a line of cannabis lotions, tinctures, edibles and lozenges that CVS started carrying in its stores last week. The CBD products are being sold over-the-counter without a prescription.

(Update: Walgreens has also announced plans to sell CBD products in 1,500 of its stores.)

CBD stands for cannabidiol, a chemical compound in marijuana that does not produce euphoria but is believed to reduce symptoms of chronic pain and other health conditions.  

“We have partnered with CBD product manufacturers that are complying with applicable laws and that meet CVS’s high standards for quality,” a CVS spokesman said in an email to MarketWatch.  

CVS said that it was selling CBD products in Alabama, California, Colorado, Illinois, Indiana, Kentucky, Maryland and Tennessee. Curaleaf executives said CVS would eventually carry its products in 800 stores in ten states.

“We’re going to walk slowly, but this is something we think our customers will be looking for,” CVS Health CEO Larry Merlo told CNBC.

‘Treated Like Criminal’ at CVS

The move is somewhat puzzling for CVS, which was one of the first pharmacy chains to crackdown on opioid prescriptions due to concerns about addiction and overdose. In 2017, CVS began restricting initial opioid prescriptions to 7 days’ supply and aligned its polices with the CDC opioid guideline.

Pain sufferers now complain they’re treated like drug addicts by CVS pharmacists.

“I submit to monthly drug tests and do everything I am supposed to do and I am treated like a criminal at the doctor and CVS pharmacy. My two pills a day barely touches the pain, but I need to work,” one patient recently told us.

“Some pharmacies, such as CVS, have taken it upon themselves to deny my prescriptions that I have been having filled there for 15 years. They first took it upon themselves to adjust my dosage. I didn’t realize that pharmacist were allowed to change a prescription,” said another patient.

“Why does CVS, a drug store that sells NSAIDs without restriction, have control of how I treat my patient?” asked one practitioner.

Although most Americans now support the use of medical marijuana and it is legal in dozens of states, the safety, effectiveness and legality of CBD is still very much up in the air.  Marijuana remains classified as a Schedule I controlled substance by the DEA, alongside heroin and LSD.

“Societies have jumped far, far ahead of science,” Dr. Margaret Haney, a professor of neurobiology at Columbia University Medical Center, told NBC News. “So it’s showing up in lotions and pretty much any form of product one can use. There’s a lot of different ways one could use CBD, but the ways we have studied CBD is much more limited.”

According to MarketWatch, Curaleaf only list its shares on the Canadian Securities Exchange because major exchanges in the U.S. and Canada will not list shares of marijuana companies due to their hazy legal status.

Study: THC More Effective Than CBD in Treating Pain

By Pat Anson, PNN Editor

The psychoactive ingredient in marijuana -- tetrahydrocannabinol (THC) – is more effective than cannabidiol (CBD) in treating chronic pain and other medical conditions, according to a new study that challenges the widespread belief that THC is harmful and has limited value in medical cannabis products.

Researchers at the University of New Mexico used the Releaf App, a mobile software program, to analyze self-reported data from over 3,300 people who logged their responses in nearly 20,000 user sessions to a variety of cannabis products, including natural dried flower, edibles, tinctures and ointments.

Dried flower was the most commonly used product and was generally associated with greater pain relief than other cannabis products, regardless of the amount of THC.

"Despite the conventional wisdom, both in the popular press and much of the scientific community that only CBD has medical benefits while THC merely makes one high, our results suggest that THC may be more important than CBD in generating therapeutic benefits,” said Jacob Miguel Vigil, PhD, a professor in UNM’s Department of Psychology.

“In our study, CBD appears to have little effect at all, while THC generates measurable improvements in symptom relief. These findings justify the immediate de-scheduling of all types of cannabis, in addition to hemp, so that cannabis with THC can be more widely accessible for pharmaceutical use by the general public.”

Hemp is a strain of marijuana that was legalized by Congress in the 2018 Farm Bill. It has very low levels of THC, but is being grown commercially as a source for CBD.

UNM researchers found that indica strains of cannabis were more effective than sativa strains in treating pain and insomnia. Both strains have substantially higher levels of THC than hemp, but are illegal Schedule I controlled substances under federal law.

“Only THC potency levels showed independent associations with symptom relief and experiences of both positive and negative side effects, with higher levels (of THC) resulting in larger effects,” Vigil said.

Researchers say the relative weakness of CBD in treating symptoms may be due to inaccurate labeling of CBD content in cannabis products, which is a widespread industry problem. It’s also possible that THC simply heightens the experience or awareness of symptom relief.

Vigil published his findings in the journal Scientific Reports. Three of his co-authors developed the Releaf App, which has collected information from cannabis users since 2016. The app is an important data source for researchers, who are currently limited in conducting clinical studies of cannabis because of federal regulations.

Two previous studies by Vigil using data from the Releaf App found that cannabis provides significant relief from a wide range of symptoms associated with chronic pain, including insomnia, seizures, depression, anxiety and fatigue.