Federal Health Agency Announces a $2 million funding to develop psychedelic treatments for substance use disorders

The National Institutes of Health is seeking proposals for research to turn psychedelics and other substances into treatments of substance use disorders (SUD). They plan to allocate $2 million to the projects in fiscal year 2025.

The funding will be used to support research on a variety of substances which could be used as addiction treatments, such as “classic psychoactives” like psilocybin, LSD and MDMA, as well as dissociatives like ketamine, and other hallucinogens including ibogaine, and its analogues. The NIH listing refers broadly to all substances as “psychedelics.”

There is an urgent requirement to develop novel treatment options for SUD, given the increasing rates of addiction and overdose. It says that psychedelics could have a therapeutic role in SUD. The ultimate goal is to develop safe and effective treatments with psychedelics for SUDs through the FDA [Food and Drug Administration] approved pathway.

The NIH announced this new funding opportunity Wednesday. Online applications will be accepted from January 28 to February 28 next year. The National Institute on Drug Abuse, a division of NIH will administer the grant.

Psychedelics Treatment Research in Substance Use Disorder (UG3/UH3 Clinical Trials Optional) https://t.co/4sJMTRzx0g

NIH funding (@NIHFunding November 1, 2020

The listing by NIH states that “despite the widespread claims about the therapeutic effects of psychedelics on substance use disorders (SUDs), the safety and efficacy of these drugs have not been sufficiently and experimentally established.” “And there are no psychedelics approved by the FDA to treat SUDs.”

In its posting, the agency admits that psychedelics can be more difficult to evaluate than other more traditional pharmaceuticals. It writes that “With psychedelic therapy, the complex interaction between pharmacotherapy, and psychotherapy, makes it hard to determine the extent to which a psychedelic drug needs a specific dosage for the therapeutic effects, as well how often and for how much time it should administered.”

The posting continued, “Therefore, it is essential to determine the optimal type and number of sessions to be used with a psychoactive drug treatment. It also includes the content, duration and frequency of those sessions.”

The goal of the project is to develop psychedelics which can treat SUDs caused by opioids, methamphetamines, cocaine, nicotine and cannabis, “or any illicit substance use except alcohol”. The posting doesn’t explain why alcohol was excluded.

The funding round does not require clinical trials. Clinical trials are not required, but applicants may submit proposals involving clinical trials. Applications “must include the entry and exit points for the proposed research plan within the FDA regulatory approval path.”

is a list of examples that NIH offers to help researchers reach their research goals.

Lead Candidate Identified: Single compound identified with adequate affinity, selectivity, pharmacokinetics, and toxicological properties to initiate advanced toxicology/safety/Drug-Drug Interaction studies.
FDA clinical hold is not required to submit an IND application.
FDA may need to conduct additional studies if there are significant objections.
FDA approval (where appropriate), that study endpoints can be used to support future development.
Phase I clinical studies with single or multiple ascending doses without significant medical safety issues or pharmacokinetic concerns identified.
Completion initial clinical efficacy tests in a phase 1b or 2A pilot study with patients who have no significant safety concerns and whose study endpoints are known.
Completion and completion of the clinical trial pilot evaluating a specific endpoint as the primary objective.
Request a meeting with FDA to receive advice on the specific configuration of a clinical drug development plan.
Proof-of-Concept study completed with all objectives met.
Completed clinical studies in intermediate-sized patient groups, with demonstrated safety and efficacy.
Successful completion of Phase 3 clinical study(s).

The posting states that applicants can request direct costs of up to $2,000,000 per year. However, the intention is to divide the $2,000,000 among 3 to 5 awards.

The program is open to a wide range of organizations including higher education institutions, nonprofits and for-profit companies, state or local governments as well as U.S. government agencies, school districts, housing authorities as well as tribal organizations, faith based groups, international entities, and school districts.

NIH announced three other funding opportunities focusing on how psychedelics can be used to treat addiction less than six month ago. The three funding opportunities all had the same goal, though one focused on psychedelic mechanisms, while the other two required clinical trials with humans. These funds totalled $1.5 million and were set to be released during fiscal year 2024.

At an earlier hearing of a Senate Committee, Nora Volkow, NIDA director, told the members that new evidence is emerging that psychedelics have “significant potential” to treat certain mental conditions.

Last year, Sens. Brian Schatz, D-HI and Cory Booker, D-NJ, urged top federal officials to give an update on studies into the therapeutic potentials of psychedelics. They argued that federal prohibition had stymied research.

NIDA’s response to the question was that the federal prohibition made it harder to study the benefits of psychedelics and required researchers to jump through extra regulatory hoops. Volkow said previously that she hesitates personally to study Schedule I drug due to these complications.

In 2021, Volkow said to Marijuana Moment that researchers should prioritize psychedelics research because more people will use the substances as they are exposed to studies showing their therapeutic potential.

While support for psychedelic therapy is growing at the federal government level , officials at the Department of Veterans Affairs have stressed the importance of proceeding cautiously in order to prevent veterans from suffering further harm.

The first episode of the new VA podcast, about the future of Veteran Health Care, focused on the healing power of psychedelics.

The first ever subcommittee of the House to focus on veterans’ mental health was supposed to meet last month . However, the event had to be postponed because Republicans were scrambling to find a speaker.

Many of the members, especially Republicans, have expressed an interest in reforming psychedelics. Rep. Jack Bergman, R-MI, for example, was the founding member of the Congressional Psychedelics Advancing Therapies. This bipartisan group was relaunched in March.

Rep. Morgan Luttrell, R-TX, has shared publicly how treatment with 5-MeO DMT and ibogaine “changed my live”. It was “one the greatest things that happened to me.”

Rep. Mariannette Miller Meeks (R – IA), the chair of the House Subcommittee, led a summer roundtable to discuss new therapies for PTSD.

House lawmakers approved a spending measure earlier this year that included amendments aimed at veterans who use marijuana or psychedelics. The first would allow VA doctors the ability to recommend medical cannabis to veterans, while the second would encourage the research of the therapeutic potentials of psychedelics.

Three bipartisan cochairs of the Congressional Cannabis Caucus sent a letter to VA Secretary Denis McDonough in August expressing their “deep concern” about a recent VA directive which continues to prevent its doctors from giving medical cannabis recommendations for veterans who live in states where marijuana is legal.

Rep. Earl Blumenauer, D-OR, one of the letter’s authors, sent a separate email to McDonough and Department of Defense secretary Lloyd Austin recently slamming both departments for perpetuating “misguided service denial” in recommending against medical marijuana use by veterans with posttraumatic stress disorder.

VA and DOD have a history of claiming to be acting in the best interests of veterans and service members, only to deny that medical marijuana is a viable treatment for those suffering from PTSD. He referred to the joint clinical practice guidelines released by the departments last July.

Blue states are leading the way in psychedelics legislation. In 2020, Oregon will legalize psilocybin treatment and decriminalize possession of all drugs. The state has approved the first legal psilocybin treatment center in May.

And in Colorado, Gov. Jared Polis (D) signed a psychedelics regulation bill into law in May, setting rules for a psychedelics legalization law that voters passed last year.

Californians are working to qualify three different psychedelics measures for the ballot in 2024. would legalize possession, sale, and regulated therapeutic uses of psilocybin. This measure has already started gathering signatures. A second proposal would create an agency that would receive $5 billion to fund and promote psychedelic research. It hopes this will help accelerate federal legalization for substances such as psilocybin, ibogaine and other psychedelics. A third campaign filed a prospective initiative to legalize psychedelics for spiritual and therapeutic use, with a doctor’s recommendation.