Ohio cannabis regulators last week added irritable bowel syndrome as a qualifying condition to use medical marijuana but declined to approve petitions to add autism and obsessive-compulsive disorder to the state’s list. 

Under Ohio’s medical marijuana laws, interested parties are permitted to petition the Ohio Medical Board to add new qualifying conditions annually. Last week, the board voted to approve petitions to add irritable bowel syndrome (IBS). But at the same time, the board announced it would not add autism or obsessive-compulsive disorder (OCD) to the list this year. 

“While this addition will help expand patient access to medical marijuana and help many Ohio patients with this condition, we are disappointed the board did not approve autism spectrum disorder and obsessive-compulsive disorder,” said Charlie Trefny, the director of government affairs for the industry group the Ohio Medical Cannabis Industry Association.

Board Followed Committee Recommendations

The board’s decisions followed the recommendations of its Medical Marijuana Committee. Dr. Frederick Slezak, the committee’s expert on IBS, said that medical marijuana use could help relieve symptoms including vomiting, pain and nausea. He also noted that cannabis can be effective for acute symptoms, while most other therapies for IBS are focused on long-term treatment.

Dr. LaRae Copley, one of the committee’s autism experts, said that there are not enough placebo-controlled studies of cannabis treatment to support adding the condition to the state’s list of qualifying conditions. The committee’s OCD expert, Dr. Timothy Kantz, said some studies showed promising results, but added that he believes the quality of some of the evidence is weak.

In both cases, the committee’s experts said the potential risks of cannabis, including psychosis, negative impacts on cognitive development and cannabis use disorder, outweighed the benefits. But patient advocates challenged that assertion.

“The available scientific evidence and the experience of countless patients and doctors tell us that there are thousands of Ohioans suffering from these conditions who could benefit from treatment with medical marijuana,” said Matt Close, the executive director of the Ohio Medical Cannabis Industry Association.

Aaron Bloom, the CEO of DocMJ, a nationwide medical marijuana physician practice, applauded the addition of IBS as a qualifying condition for Ohio’s medical cannabis program. But he added that we should “strive for a healthcare system that values the expertise of medical professionals and respects the diverse needs of patients.”

“To truly harness the full potential of medical cannabis, it is essential that doctors are empowered to exercise their professional judgment and recommend it for patients based on their individual needs rather than being limited by a predefined list of approved conditions,” Bloom wrote in a statement to High Times. “By allowing doctors to make informed decisions about medical cannabis recommendations, we can ensure that patients receive the best possible care and have access to a comprehensive range of treatment options.”

More Than A Dozen Qualifying Conditions

Ohio’s medical marijuana program currently lists more than a dozen qualifying medical conditions that make a patient eligible to use cannabis medicinally, including acquired immune deficiency syndrome, Alzheimer’s disease, amyotrophic lateral sclerosis, cancer, chronic traumatic encephalopathy, Crohn’s disease, IBS, epilepsy or another seizure disorder, fibromyalgia, glaucoma, hepatitis C, inflammatory bowel disease, multiple sclerosis, Parkinson’s disease, positive status for HIV, post-traumatic stress disorder, sickle cell anemia, spinal cord disease or injury, Tourette’s syndrome, traumatic brain injury, ulcerative colitis, and chronic and severe or intractable pain.

The next opportunity to submit petitions to the Ohio Medical Board to add new qualifying conditions to the state’s medical marijuana program begins on November 1 and runs through December 31. In order for the board to reconsider conditions that have been previously rejected, petitioners must submit new scientific information to support the proposed change.

Recreational Marijuana Legalization Could Be Next

Ohio activists are also working to legalize recreational cannabis in the state, with a proposed ballot measure likely appearing on ballots later this year. Earlier this month, the Coalition to Regulate Marijuana Like Alcohol submitted petitions for a legalization initiative with more than 222,000 signatures to the Ohio Secretary of State’s office. To qualify for the ballot for the November election, state officials must certify about 125,000 signatures, giving the group a significant margin to account for signatures deemed invalid. 

“We are thrilled to have reached this milestone,” campaign spokesperson Tom Haren said in a statement when the signatures were submitted. “This is a testament to the hard work of our campaign and the support of Ohio voters who are ready for common-sense marijuana reform.”

If passed, the proposed ballot initiative would legalize recreational marijuana in Ohio for adults 21 and older, who would be permitted to possess up to 2.5 ounces of marijuana and up to 15 grams of cannabis concentrates. The proposal also legalizes marijuana cultivation for personal use, with adults allowed to grow up to six cannabis plants. Households with more than one adult would be permitted to grow a total of 12 plants.

The commercial production and sales of cannabis products would be regulated by a new state agency dubbed the Division of Cannabis Control, which would have the authority to “license, regulate, investigate, and penalize adult use cannabis operators, adult use testing laboratories, and individuals required to be licensed.” Cannabis products would carry a 10% tax, which would be dedicated to administrative costs of regulation, substance misuse treatment programs and a social equity and jobs program. Municipalities with licensed recreational marijuana dispensaries would also receive a share of cannabis tax revenue. Under the proposal’s social equity program, some cannabis cultivation and dispensary licenses would be reserved for individuals from communities that have faced disproportionate enforcement of Ohio’s current marijuana laws.

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The United States Food and Drug Administration, aka the FDA, issued the first-ever guidance for clinical studies on psychedelics, according to a news release issued Friday. They filed the 14-page document shortly after Congress introduced bipartisan legislation led by Texas Republican Representative Dan Crenshaw, directing the issuance of clinical trial guidelines.

They aimed the guidance specifically towards classical psychedelics, which include psilocybin, LSD, mescaline, and DMT, the psychoactive ingredient in ayahuasca, in addition to entactogens or empathogens such as MDMA. This means that it does not cover other drugs used therapeutically embraced by the psychedelic community, such as ketamine, which is technically a dissociative anesthetic that has hallucinogenic effects.

While the FDA guidance is new, research on the benefits of psychedelics is not. Applied Clinical Trials reports that there are currently 163 Phase I, II, or III studies on clinicaltrials.gov involving psychedelics. For instance, in January, MAPS Public Benefit Corporation, a biopharmaceutical company dedicated to psychedelic treatment, announced its Phase 3 clinical trial on MDMA-assisted therapy for post-traumatic stress disorder (PTSD) produced promising results.

“The Phase 3 confirmatory results support the development of MDMA-assisted therapy as a potentially new breakthrough therapy to treat individuals with PTSD—a patient population that is often left to suffer for years,” said Amy Emerson, chief executive officer of MAPS Public Benefit Corporation. MAPS plans to submit the new drug application to the FDA in the third quarter of 2023.

Like MAPS’ study on MDMA, psychedelic research to date has primarily been backed by private sponsors. Many of these may want nothing to do with the Feds and their infamously regressive views on psychedelics. The FDA approval process is expensive and riddled with red tape. Many companies may prefer to follow state guidelines and leave psychedelics, such as psilocybin, which researchers currently study for OCD, and alcohol use disorder, nestled in the safety of libertarian-esque gray areas. (Oregon and Colorado are the only states to decriminalize the supervised use of psychedelics). 

For example, let’s look at ketamine, which, as noted, is not technically a psychedelic. While Esketamine, or S-ketamine, the S enantiomer of ketamine, is FDA-approved as a nasal spray, many ketamine clinics and psychiatrists prefer to prescribe patients actual ketamine, off-label, because it’s not only more affordable but may work better than the version the FDA approved, which was only changed to S-ketamine in the first place so Johnson & Johnson could patent it under the brand name Spravato. 

However, if a substance earns FDA approval, it is easier to market and sell and could reach more consumers who trust that it’s met the FDA decision that the benefits outweigh the risk. For instance, Tryp Therapeutics is currently seeking FDA approval for psilocybin-assisted therapy to help those with irritable bowel syndrome (IBS).

While such studies show that psychedelics hold great therapeutic potential, as anyone with personal experience using psilocybin, MDMA, or other psychedelics can attest, the FDA asserts that they must address the challenges associated with designing clinical studies to evaluate the safety and effectiveness of psychedelics.

“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies,” said Tiffany Farchione, M.D., director of the Division of Psychiatry at CDER.1, Applied Clinical Trials reports. 

The guidance addresses the psychoactive and hallucinogenic effects of psychedelics, the potential for abuse, and the importance of conscientious safety measures. It includes considerations for the importance of characterizing dose-response and the durability of any treatments. The draft also tackles potential drug interactions for patients on antidepressants or mood stabilizers such as lithium. 

Additionally, for any Schedule I controlled psychedelics, the FDA states that the research must comply with applicable Drug Enforcement Administration (DEA) regulatory requirements. 

It also tackles the role of psychotherapy within a psychedelic treatment, what folks in the community often describe as integration, or the therapeutic process of a patient going through therapy with a professional to integrate their experience into everyday life, ensuring that it’s not just a one-time trip, but an ongoing treatment plan. 

If anyone has thoughts on the draft guidance, the FDA accepts public comments for 60 days. 

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The Minnesota Department of Health announced on Wednesday that the agency will add irritable bowel syndrome and obsessive-compulsive disorder to the list of qualifying medical conditions for participation in the state’s medical cannabis program. Under state law, the addition of the new qualifying conditions will become effective beginning on August 1, 2023, according to state officials.

“We are adding the new qualifying conditions to allow patients more therapy options for conditions that can be debilitating,” Minnesota Commissioner of Health Jan Malcolm said in a statement from the health department.

Irritable bowel syndrome (IBS) is a disorder characterized by abdominal pain or discomfort, as well as irregular bowel movements that can result in diarrhea, constipation, both diarrhea and constipation, or bloating. Obsessive-compulsive disorder (OCD) is characterized by recurring, intrusive thoughts that often cause significant emotional distress and anxiety in those living with the disorder. This can lead to repetitive actions or other behaviors that those affected by the condition feel compelled to perform to reduce that distress.

“Research has shown that people who suffer from these conditions can see benefits from using medical cannabis to treat their symptoms,” the health department wrote. 

The new qualifying conditions offer a modest expansion to the state’s medical cannabis program, with an estimated 10% of adults having IBS and 1% meeting the diagnostic criteria for OCD, according to media reports. 

Minnesota Patients Support Adding New Conditions

In public comments on the petitions to add IBS and obsessive-compulsive disorder to Minnesota’s medical marijuana program, a man identified by the initials RH described himself as a working professional with a wife and two daughters.

“My daily life consists of constant fear and stress,” said RH, who noted he has OCD. “Practically the only time I am free of the symptoms is when I am sleeping.”

Under state rules, patients certified for the newly approved qualifying medical conditions will become eligible to enroll in the state’s medical cannabis program on July 1, 2023. Patients will be able to receive medical cannabis from either of the state’s two medical cannabis manufacturers beginning on August 1, 2023. Patients who wish to use medical marijuana to treat any of the state’s qualifying conditions need advance certification from a participating Minnesota healthcare provider.

Opioid Use Disorder Not Approved

The health department declined to approve petitions to add opioid use disorder and gastroparesis, a condition that affects the normal spontaneous movement of the stomach muscles, to Minnesota’s list of conditions that qualify a patient to use medical marijuana. The petition not to add gastroparesis was not approved as a qualifying medical condition because research indicates that cannabis can make the condition worse.

Chris Tholkes, director of the Minnesota Department of Health’s Office of Medical Cannabis, said that the decision not to add opioid use disorder was a difficult one, noting that limited access to existing treatment options, such as methadone clinics, in some geographic areas was one factor that supported approval of the petition.

“We did struggle with this one,” Tholkes told the Star Tribune, adding that medical providers were concerned that “introducing another type of drug could lead to relapse. And in the case of opioid use, relapse can be fatal.”

The decision not to approve opioid use disorder comes as Minnesota and the nation remain in the grips of an opioid overdose death epidemic. Many public comments revealed success in substituting marijuana for opioids.

“After having gone (through) nine years of painkiller use under medical prescription for pain, I know that the use of cannabis would help ease the withdrawal side of it,” said a commenter, identified publicly by the initials TB. “I only use cannabis now.”

When Minnesota lawmakers passed legislation creating the state’s medical cannabis program in 2014, the law included nine conditions that qualified a patient to receive medical cannabis. With the new additions, the list of qualifying conditions will be 19. Current qualifying conditions include chronic pain, post-traumatic stress disorder (PTSD), cancer in certain circumstances, glaucoma, and other serious medical conditions.

More than 39,000 Minnesotans are enrolled in the state’s medical marijuana program, up from 29,000 in 2021. Almost all registered participants are qualified because of intractable or chronic pain, and about a third for PTSD. Muscle spasms, cancer, and sleep apnea are also common qualifying conditions.

New Conditions Considered Annually

Each year, the health department conducts a formal petition process to solicit public input on potential qualifying medical conditions and delivery methods, followed by a public comment period and a review panel.

Under state rules, the commissioner of health is required to annually consider new petitions to add qualifying medical conditions and cannabis delivery methods. No petitions for new delivery methods were submitted this year.

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Not much research has been done on cannabis and OCD, but other studies suggest it can be highly beneficial for OCD symptoms. Read on to see what the science says.

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