Psychedelic medicine studies have increased over the last decade, from studying MDMA in PTSD to treating major depressive disorder with DMT. But how does research into Schedule 1 substances work? Where do these studies get their psychedelics? Let’s answer these questions and more in this Comprehensive Guide to Psychedelic Clinical Trials.
Hundreds of psychedelic clinical trials are going on right now worldwide. Academic institutions, drug developers, and independent research centers are gathering data on safety and efficacy. Some substances are already in the earliest stages of commercialization, with late-stage clinical trials paving the way for FDA approval.
Still, psychedelics are only just beginning to shrug off their negative connotations. The slander campaigns of the 60’s left their mark on modern perceptions. Many Americans associate psychedelics with party drugs and youth delinquency. And their DEA scheduling creates layers of red tape that still limits the number of approved trials.
Full transparency throughout the research process shows people that psychedelics can be a legitimate medical treatment. From the outside, the clinical trial process can seem murky. Getting clear about the logistics of psychedelic research can help people understand how they work and even help them get into a clinical trial.
Psychedelic Support is at the forefront of psychedelic medicine advocacy, community, and education. We’re enthusiastic to see a growing list of current clinical trials. We want to see more people interested in research because it means rigorous science to know what actually works. The psychedelic medicine community is going to exciting places in the next several years. You can be a part of this fascinating, growing branch of medicine.
If you’re interested in psychedelic research, you’re probably wondering what it’s like to be a researcher. What do the logistics of this field look like? What red tape do researchers need to navigate to contribute to the growing body of psychedelic knowledge? Let’s talk about logistical challenges in psychedelic research and how investigators get psychedelics.
How Do Studies Get Psychedelics?
It may surprise you to learn that researchers often get psychedelic substances through the federal government. The National Institute on Drug Abuse (NIDA) maintains a catalog of drugs that researchers can request. These include MDMA, ibogaine, LSD, and more. NIDA provides these substances free of charge to researchers under their Division of Therapeutics and Medical Consequences (DTMC).1
There are specific alternatives for research psychedelics. Ceruvian Lifesciences announced that they’ll provide cost-free LSD to researchers. Their GMP (Current Goods Manufacturing Practices) LSD is the first to meet strict standards by the FDA. This boosted availability will help increase access to study psychedelics, and help decrease the cost of research.
Still, most researchers source their substances from NIDA. They have a request process for each class of substances in their catalog. Researchers have to jump through several hoops before even being able to put their requests to NIDA. To begin the request process, researchers must submit an extensive Request Package. This package includes:2
- A cover letter
- The NIH grant number, if applicable
- The name and quantity of the requested substance
- The research investigator’s curriculum vitae: a summary of their experience and skills
- The research protocols, including study goals, number of participants, and dosage of substances
- Commitment to acknowledging NIDA for their contributions to research
- The DEA order form that corresponds to the Schedule of substances being requested
- The DEA registration form for controlled substances
- Safety forms, including a copy of the FDA approval letter for use on human subjects, the Institutional Review Board (IRB) letter, the Data Safety and Monitoring Plan, registration with clinicaltrials.gov, and subjects’ consents
Not only does NIDA give substances to research trials in the United States, but other countries also depend on them for sourcing substances. They partner with some institutions on projects that further addiction research as well. In 2021, NIDA partnered with Delix Therapeutics to research an ibogaine analog in treating substance use disorders.3
Notice that NIDA requires forms from other organizations, such as NIH grant forms, DEA order and registration forms, and registration with clinicaltrials.gov. Requesting psychedelic substances comes after full approval from the DEA and federal trial registration. Let’s discuss what that looks like.
How Do Researchers Get Approved to Study Psychedelics?
The research approval process is extensive, even more so in the case of controlled substances like psychedelics. Researchers must gain approval and registration from several entities before even considering requesting substances. And before that, research organizations need to achieve the staffing and funding to host studies.
The approval can take months to years. Sometimes researchers have to go back and make changes to their trial plan before gaining the next approval step. Here are the general steps researchers must follow to gain approval for psychedelic trials:
- Grants and Funding: Conducting clinical trials isn’t cheap. Academic researchers typically rely on institutional grants, which aren’t easy to come by. For instance, last year Johns Hopkins got the first federal grant in five decades to conduct psychedelic research for a health condition (nicotine dependence).4 The funding process can take years, and many researchers get bogged down in this early stage. Most academic psychedelic research has relied on philanthropic donations.
- Institutional Review Board (IRB) Approval: Researchers first have to show the board that their study will benefit the public. They have to account for patient risks and show that they plan to treat subjects with respect. Getting approval isn’t a given – some researchers need to modify their plan to gain the go-ahead.5
- Drug Enforcement Agency Registration: Researchers have to document and show the DEA why they want to study a scheduled substance, how they’ll conduct research, and how to prevent the substance from being diverted. This can now be done through the DEA’s web portal.6
- Substance Acquisition: After funding acquisition, IRB, and DEA approval, researchers can request substances. This typically happens through NIDA, which gets its substances through licensed manufacturers in the US. These substances and accompanying therapies aren’t cheap – for one Phase III trial, MAPS reported costs of more than $11,500 per participant.7
The strict process for approval limits the speed of psychedelic research. But it also protects study participants and ensures that researchers report data ethically.
But why all this regulation around research and psychedelics? And why are we only now seeing a resurgence of interest in psychedelic medicine? Let’s talk about how we got to this point with regulation and research.
Psychedelics Research: A Brief History
The history of psychedelic research contributes to logistical difficulties in the field today. Some rules and regulations reflect the violations of researchers in years past. Some are hold-outs from legislation that we hope will change in the coming years.
Psychedelics study has a checkered history. The National Institute of Health sponsored much of the early research. Between the 50s and 60s, their popularity in research and recreation soared.8 Lax regulations allowed ethical violations, like experimenting on inmates and restraining subjects.
Amidst a rising tide of conservatism, Nixon passed the Controlled Substances Act in 1970. Suddenly, possessing and using psychedelics was a felony. Psychedelics were deemed Schedule 1, meaning they had no medical use and strong potential for abuse.9 This cut off psychedelic research at the knees and made the process of researching it much more complicated.
The Controlled Substances Act was closely followed by Nixon’s National Research Act of 1974. Now, studies are required to demonstrate the public benefits of research into behavioral and biomedical trials. That’s why Institutional Review Boards (IRB) were established to protect patients and ensure they were treated well.10
These new regulations became a double-edged sword for researchers. It’s a benefit that research participants are protected. We must treat subjects with dignity and respect. Yet increased red tape around federally controlled substances meant that psychedelic research slowed to a trickle until the new millennium.
Where Is Psychedelic Research Now?
Today’s clinical trials are much more ethical and regulated than the ones of the 40s and 50s. As you’ve seen, the approval process for research is extensive. This slows down the process of research approval. In return, it means volunteers are protected and outcomes are measured more precisely.
Still, there are some barriers that we hope to see come down in the following decades. Getting psychedelics de-scheduled will help researchers access them with one less layer of red tape. De-scheduling will also prevent people from suffering legal consequences related to psychedelics.
It’s easy to complain about how regulations make research more difficult. But in the modern research process, subjects are safe. While research may not always move as quickly as we’d like, participant safety is of the utmost importance.
At Psychedelic Support, we’re paying close attention to current clinical trials, and we want to make it easy for you to get involved. If you’re interested in participating in research, check out our article about five things to know before joining a clinical trial.
Are you pursuing a career in psychedelic therapy and research? We’d love to have you join our professional community. Through our Professional Connect, you can let trial sponsors know you are interested in being a therapist in a study, and receive client referrals after participants complete trials. Join our network here.
References
[1] U.S. Department of Health and Human Services. (2022, May 20). Nida Drug Supply Program. National Institutes of Health. Retrieved July 9, 2022, from https://nida.nih.gov/research/research-data-measures-resources/nida-drug-supply-program
[2] National Institute on Drug Abuse. (Oct. 2019). NIDA Drug Supply Program Catalog.
[3] Cameron LP, Tombari RJ, Lu J, Pell AJ, Hurley ZQ, Ehinger Y, Vargas MV, McCarroll MN, Taylor JC, Myers-Turnbull D, Liu T, Yaghoobi B, Laskowski LJ, Anderson EI, Zhang G, Viswanathan J, Brown BM, Tjia M, Dunlap LE, Rabow ZT, Fiehn O, Wulff H, McCorvy JD, Lein PJ, Kokel D, Ron D, Peters J, Zuo Y, Olson DE. A non-hallucinogenic psychedelic analogue with therapeutic potential. Nature. 2021 Jan;589(7842):474-479. doi: 10.1038/s41586-020-3008-z. Epub 2020 Dec 9. PMID: 33299186; PMCID: PMC7874389.
[4] Johns Hopkins Medicine receives first federal grant for psychedelic treatment research in 50 Years. Johns Hopkins Medicine Newsroom. (2021, October 18). Retrieved July 9, 2022, from https://www.hopkinsmedicine.org/news/newsroom/news-releases/johns-hopkins-medicine-receives-first-federal-grant-for-psychedelic-treatment-research-in-50-years
[5] Center for Drug Evaluation and Research. (n.d.). (irbs) and protection of human subjects. U.S. Food and Drug Administration. Retrieved July 9, 2022, from https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards
[6] United States Drug Enforcement Agency. (2018, January 18). DEA speeds up application process for research on Schedule I drugs. DEA. Retrieved July 9, 2022, from https://www.dea.gov/press-releases/2018/01/18/dea-speeds-application-process-research-schedule-i-drugs
[7] Marseille E, Mitchell JM, Kahn JG. Updated cost-effectiveness of MDMA-assisted therapy for the treatment of posttraumatic stress disorder in the United States: Findings from a phase 3 trial. PLoS One. 2022 Feb 25;17(2):e0263252. doi: 10.1371/journal.pone.0263252. Erratum in: PLoS One. 2022 Jun 2;17(6):e0269623. PMID: 35213554; PMCID: PMC8880875.
[8] Petranker, R., Anderson, T., & Farb, N. A. (2020). Psychedelic research and the need for transparency – polishing Alice’s looking Glass. https://doi.org/10.31234/osf.io/vgt3r
[9] DEA. 25 July, 2018. The Controlled Substances Act. Retrieved from https://www.dea.gov/drug-information/csa on 8 July, 2022
[10] Centers for Disease Control and Prevention. (2021, April 22). Tuskegee Study – Research Implications – CDC – NCHHSTP. Centers for Disease Control and Prevention. Retrieved July 9, 2022, from https://www.cdc.gov/tuskegee/after.htm
