Psychedelics Clinical Trials Challenged By Size

There are more and more clinical trials for various psychedelic substances cropping up all the time. Some have completed phase III trials, others are closing in on phase III, the final step before FDA approval leading up to an approved drug that can be brought to market.

But the scientific community is saying “not so fast.” Some of these trials are using very small groups of participants—for example, a Phase II psilocybin clinical trial by Johns Hopkins University used 27 participants, while recommendations for Phase II clinical trials vary from a few dozen to 300 patient volunteers. An MDMA-for-PTSD clinical trial completed Phase III with just 100 participants—Phase III trials usually require 300 to 3,000 participants.

Other researchers are finding that getting qualified participants is particularly challenging due to the time commitment required and other detailed inclusion criteria issues.

And intense media attention could potentially undermine psychedelic clinical trials, resulting in strong pressure from some advocacy groups to fast-track, or even bypass, clinical research and rapidly implement it. “Undue haste in translation to community clinics could compromise essential aspects of efficacy, safety, and equity, ultimately threatening the sustainability of psychedelic-assisted therapies,” authors wrote in an article in “Psychiatry.” 

A study published in “Frontiers in Psychology” about the growing problems with psychedelics clinical trials spells out other issues: “Psychedelics have a checkered past, alternately venerated as sacred medicines and vilified as narcotics with no medicinal or research value. Given psychedelics’ complex history, it is especially important to proceed with care, holding ourselves to a higher scientific rigor and standard of transparency. Universities and researchers face conflicting interests and perverse incentives, but we can avoid missteps by expecting rigorous and transparent methods in the growing science of psychedelics.” 

The study also explained that the resurgence of psychedelic research coupled with profits from cannabis legalization has led to converging clinical, philanthropic, financial, and private industry interest in psychedelics.

The upside of growing public interest is that well-respected (and well-funded organizations) such as the Usona Institute, Multidisciplinary Association for Psychedelic Studies (MAPS), Johns Hopkins University, the Heffter Research Institute, the Beckley Foundation, and others have jumped into helping develop better psychedelics research, along with a handful of psychedelics companies. 

But even with those organizations and companies providing research by renowned scientists, psychedelics research is being done in a field characterized by both pro-and anti-drug agendas, according to the study. “Mainstream narratives are fragile: current excitement favoring psychedelics’ potential could swing swiftly back toward prohibition rhetoric following the emergence of clinically adverse events. Peer-reviewed research provides a more stable foundation for policy recommendations, but only when the research is rigorous and transparent.”

The methodology of psychedelics trials—with one group being given a psychedelic, and another being given a placebo as part of the randomized controlled trial—has been called into question recently. 

One Canadian research team from McGill University in Montreal tested the structure of controlled psychedelics trials with surprising results, as reported in “Psychopharmacology” in March, 2020. Thirty-three students completed a study examining how a psychedelic drug affects creativity. They all took a placebo that was described as a (fictional) drug resembling psilocybin. Other participants working with the research team pretended to act out the effects of the drug, leading the participants to believe that there was no placebo control group. The majority (61%) of participants verbally reported some effect of the fictional non-psychedelic placebo drug. Several stated that they saw the paintings on the walls “move” or “reshape” themselves, others felt “heavy… as if gravity [had] a stronger hold”, and one had a “come down” before another “wave” hit her. 

McGill researchers found a silver lining in this experiment, concluding that understanding how context and expectations promote psychedelic-like effects, even without the drug, may help researchers isolate drug effects to maximize their therapeutic potential.

There is also a belief that clinical research is useless. Useful clinical research should add to what we already know, according to an article by John Ioannidis, professor of medicine in the Department of Health Research and Policy, Stanford University School of Medicine. “This means that, first, we need to be aware of what we already know so that new information can be placed in context,” he wrote. 

Studies should be designed to provide enough evidence to ensure that patients, clinicians, and decision-makers can be confident about the magnitude and specifics of benefits and harms, and these studies should be judged based on clinical impact and their ability to change practice, according to the article. “Reform and improvement are overdue,” Ioannidis wrote.

Solutions for better psychedelics studies that have been proposed include pre-registration, open materials and data, constraints on generality, and replication, which are the best practices for any scientific endeavor and particularly for psychedelics research, as noted in the “Frontiers in Psychology” study. “We recommend working with a university or other recognized institution when studying scheduled substances, obeying the law, and hiring legal counsel to review potential agreements with industry partners,” the study concluded.  “This is an exciting time to study psychedelics, but getting the science right should be our top priority.”

Dave Hodes

David Hodes is a business journalist based in the Washington D.C. metropolitan area. He has contributed feature articles to several cannabis and psychedelics publications, as well as general business/lifestyle publications, on a variety of topics. Hodes was selected as 2018 Journalist of the Year by Americans for Safe Access. He is a member of the National Press Club, and the deputy booking agent for the National Press Club Headliners Committee.

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