The National Institutes of Health (NIH) is soliciting proposals to develop psychedelics into treatments for substance use disorder (SUD), with plans to issue $2 million in grant money toward the research projects during fiscal year 2025. The funding opportunity will support research into a range of substances that might be used treat addiction, including “classic psychedelics” such as psilocybin and LSD, empathogens such as MDMA, dissociatives such as ketamine and other hallucinogens, including ibogaine and its analogues. The NIH listing refers to all the substances broadly as “psychedelics.” “There is an urgent need to develop novel treatments for SUD in light of the escalating rates of substance use, addiction, and overdose. Psychedelics may offer a new potential therapeutic use in SUD,” it says. “The ultimate goal is to advance the development of safe and effective treatments for SUDs with psychedelics in the FDA [Food and Drug Administration] approval pathway.” NIH announced the new funding opportunity on Wednesday. Applications will be accepted online from January 28 through February 28 of next year. The National Institute on Drug Abuse (NIDA), a division of NIH, will administer the grant program.
“Despite the widespread claims of the therapeutic effects of psychedelics for substance use disorders (SUDs), their safety and efficacy have not been sufficiently and empirically established,” NIH says in the listing, “and there are no psychedelics that are approved by the FDA for the treatment of SUDs.” The agency acknowledges in the posting that psychedelics are more complicated to evaluate than many more traditional pharmaceuticals, writing that, “With psychedelic therapies, the complex interplay between pharmacotherapy and psychotherapy makes it difficult to establish the degree to which the psychedelic drug requires a specific dose for the therapeutic effect, as well as how frequently and for how long it should be administered.” “Therefore,” the posting continues, “it is essential to establish the optimal type of psychotherapy to use with a psychedelic drug treatment, the number of the sessions required, as well as their content, duration, and frequency.” The goal is to further develop psychedelics that can treat SUDs for opioids, methamphetamine, cocaine, nicotine, cannabis “or any other illicit substance use, except alcohol.” The posting does not clarify why alcohol is excluded. Clinical trials for the funding round are optional. Applicants may submit proposals that involve clinical trials, but it’s not a requirement. However, applications “must provide the entry and exit points of the proposed research plan in the FDA regulatory approval pathway.” Examples that NIH provides of potential research milestones include, as listed in the posting:
Psychedelics Treatment Research in Substance Use Disorder (UG3/UH3 Clinical Trials Optional) https://t.co/4sJMTRzx0g— NIH Funding (@NIHFunding) November 1, 2023
- Lead Candidate Identified: Single compound identified with adequate affinity, selectivity, pharmacokinetics, and toxicological properties to initiate advanced toxicology/safety/Drug-Drug Interaction studies.
- File Investigational New Drug (IND) application without clinical hold imposed by the FDA.
- No significant objections that may require additional studies by the FDA following Investigational New Drug filing.
- FDA agreement (where appropriate) that study endpoints are acceptable to support further development.
- Completion of Phase I single and/or multiple ascending dose clinical studies without significant medical safety or pharmacokinetic issues identified.
- Completion of initial clinical efficacy testing in a pilot phase 1b or phase 2A study in patients without significant safety issues identified and with study endpoints ascertained.
- Completion of the pilot clinical trial assessing a certain endpoint of interest as a primary objective, where the objectives were fulfilled and Go/No-Go criteria were answered.
- Meeting with the FDA for advice on specific clinical drug development plan configuration is requested.
- Completion of the Proof-of-Concept trial with study objectives attained.
- Completion of clinical study in intermediate-size patient groups with safety and efficacy demonstrated.
- Phase 3 Clinical study(s) successfully completed.