A pilot program on the benefits of synthetic psilocybin for mental health issues like post-traumatic stress disorder (PTSD) is set to begin this summer at Yale University in New Haven, Connecticut. 

A study cohort will consist of 50 patients, mostly veterans and first responders, who are with mental health concerns like depression and addiction. Participants will take 25 mg of synthetic psilocybin, and after the psychedelic effects wind down, they will discuss issues and progress (or lack thereof) with trained therapists.

Connecticut Post reports that the goal is to fulfill the need for state data that has been lacking, according to state Rep. Michelle Cook (D-Torrington).

“We need to have the data to show that there is documented proof of what that therapy does,” Cook said. “We know that it has some incredible outcomes when it is done right, when it’s done by people that are trained in how to use it for treatment of PTSD and so forth.”

Researchers at Yale have been studying the “psychological, neurobiological, and therapeutic effects of psychedelic substances” like psilocybin for decades..

Using a Schedule 1 drug in a clinical setting creates a set of unique problems, including the inability to use insurance. “Even though it’s a research program, you are treating them clinically. And then, in order to treat them clinically, you need to have malpractice coverage,” said Yale researcher Ben Kelmendi. Kelmendi and his team are about to embark on a first-of-its-kind study, a pilot program at Yale.

Research on the medical benefits of  psilocybin have been severely hampered due to legal restrictions, Kelmendi said. Only certain qualifying conditions are acceptable in this case. PTSD, for instance, is a complex issue that many people fail to treat.

“With veterans, they will not seek treatment right away,” Kelmendi said. “They will start turning to alcohol or other substances, and so that now they have a comorbidity, and that comorbidity—which really is their own way of coping—will exclude them from the study. They are real patients who are actually suffering and who actually need help. They cannot access these medicines because they do not fit that cookie-cutter profile.” 

The impact of PTSD is hard to define as it affects multiple aspects of daily life.

“There is no one scale that actually captures the complexity of one’s daily functional impairment. It’s actually an index of several different scales,” he said. “One is days missed at work, productivity and relationships, just more daily living. I think that is much more important than saying ‘Oh, have your PTSD symptoms improved or not?’”

Participants will take 25 mg of synthetic psilocybin, enough to induce a psychedelic experience, and the therapy is patient-directed. They will be taken in a comfortable space and about six hours later, participants will undergo a psychotherapy session. 

“Twenty-five milligrams would be considered a moderate dose. It’s not a heroic dose necessarily, but it’s a psychoactive dose, for sure,” Kelmendi said. “The non-directive supportive psychotherapy is to be done after the dosing rather than during the dosing.”

The Many Potential Health Benefits of Psilocybin 

The Yale Program for Psychedelic Science supports this goal with several currently active studies on psilocybin. These include studies on Obsessive Compulsive Disorder (OCD), Major Depressive Disorder (MDD), cluster headaches, post-traumatic headaches, and migraines. Kelmendi is working on several of them.A 2022 report published by a working group under the direction of the Connecticut Department of Mental Health and Addiction Services, was clear about the potential of psilocybin in therapeutic medicine. 

Even people who don’t necessarily intend to gain benefits for mental health from psilocybin are still benefitting, a separate study suggests. A study published last September found that using psilocybin outside of a clinical setting was associated with mental health benefits including decreases in anxiety and depression. The research, which was published September in the journal Frontiers in Psychiatry, studied nearly 3,000 people who reported on their experience taking psilocybin mushrooms. 

To conduct the study, which is reportedly the largest study of psilocybin in a naturalistic (non-clinical) setting, researchers spent two years collecting data from 2,833 participants who planned to take psilocybin for purposes of “self-exploration.” Most participants were college-educated white men in the United States who had previous experience taking psychedelic drugs.

The study participants were asked to fill out five surveys as part of the research. The first survey was completed two weeks prior to the psilocybin experience, which usually consisted of ingesting dried mushrooms, and again the day before the planned psychedelic trip. The remaining surveys were taken one to three days after the experience, two to four weeks after and two to four months after taking the psilocybin. 

After analyzing the data from the surveys, researchers determined that participants reported long-lasting reductions in anxiety, depression, alcohol misuse, neuroticism and burnout. Additionally, the participants reported improvements in cognitive flexibility, emotion regulation, spiritual well-being and extraversion. The new research aims to add to the body of knowledge of what is known about the effects of psilocybin.

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One of the country’s most prestigious academic institutions will be home to a new research center dedicated to studying cannabis. 

The Yale School of Medicine announced the creation this week of “a research center to study the acute and chronic effects of cannabis and cannabinoids on neurodevelopment and mental health.”

Called the “Yale Center for the Science of Cannabis and Cannabinoids,” the center “will be led by Deepak Cyril D’Souza, MD, Albert E. Kent Professor of Psychiatry and a leading expert on the pharmacology of cannabinoids.”

The announcement comes only weeks after Connecticut, where the elite Ivy League university is located, launched legal recreational cannabis sales. 

After the regulated marijuana market went live, D’Souza sounded the alarm on cannabis use among young people. 

“It’s easy for adolescents to get their hands on tobacco and alcohol and why do we think that’s not going to be the case with cannabis,” D’Souza told local news station WTNH.

“Exposure to cannabis … in adolescents has been associated with the development of some serious psychiatric disorders including schizophrenia and other psychosis,” D’Souza added, as quoted by the station.

The center, which was announced by the university on Monday, will be funded initially by “the Department of Psychiatry, with support from the dean’s office.”

“Funding will support pilot studies toward the development of a P50-type center grant application…” the university said in the announcement, noting that those interested in applying for funding must contact D’Souza.

According to a press release about the new cannabis research center, university leaders “said in their announcement that the launch of the center comes at a time of rapid commercialization of cannabis across the United States,” and that the new “center will use a multipronged and multidisciplinary approach to study the acute and chronic effects of cannabis and cannabinoids.” 

Legal recreational pot sales kicked off in Connecticut last month. According to WTNH, the first week of sales brought in more than $2 million. 

The state legalized marijuana in 2021, when Democratic Gov. Ned Lamont, who was elected to another term in last year’s election, signed a bill into law.

“That’s why I introduced a bill and worked hard with our partners in the legislature and other stakeholders to create a comprehensive framework for a securely regulated market that prioritizes public health, public safety, social justice, and equity. It will help eliminate the dangerous unregulated market and support a new, growing sector of our economy which will create jobs,” Lamont said in a signing statement at the time. “By allowing adults to possess cannabis, regulating its sale and content, training police officers in the latest techniques of detecting and preventing impaired driving, and expunging the criminal records of people with certain cannabis crimes, we’re not only effectively modernizing our laws and addressing inequities, we’re keeping Connecticut economically competitive with our neighboring states.” 

Lamont announced in December that, as part of the state’s new cannabis law, about 44,000 individuals would have their prior marijuana convictions expunged at the beginning of 2023.

“On January 1, thousands of people in Connecticut will have low-level cannabis convictions automatically erased due to the cannabis legalization bill we enacted last year,” Lamont said in a statement at the time. “Especially as Connecticut employers seek to fill hundreds of thousands of job openings, an old conviction for low-level cannabis possession should not hold someone back from pursuing their career, housing, professional, and educational aspirations.”

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