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 psychedelics that might be used treat SUD, including psilocybin, LSD, MDMA, ketamine and other hallucinogens including ibogaine and its analogues.
“Psychedelics may offer a new potential therapeutic use in SUD,” the listing states. “The ultimate goal is to advance the development of safe and effective treatments for SUDs with psychedelics in the [Food and Drug Administration] approval pathway.”
NIH announced the new funding opportunity on October 31. Applications will be accepted online from January 28 through February 28 of 2024. 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 [SUD] there are no psychedelics that are approved by the FDA for the treatment of SUDs,” the listing continues. “[T]he 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.”
Applicants may submit proposals that involve clinical trials, but it’s not a requirement.
The goal is to further develop psychedelics that can treat SUD for “opioids, methamphetamine, cocaine, nicotine, cannabis or any other illicit substance use, except alcohol.”
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.
– 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.
– DA 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.
Several types of organizations are eligible, including nonprofits both with and without 501(c)3 status.
Applicants can request up to $2 million per year for direct costs, but the posting says that the intent is to split up the $2 million among three to five awards.
Several types of organizations are eligible, including nonprofits, businesses, individual local, state or federal agencies, institutions of higher education, school districts, housing authorities, tribal organizations, faith-based groups and international entities.
The announcement comes less than six months after NIH posted three other funding opportunities focused on how psychedelics could be used to treat SUD. All three focused on the same overall objective, but one would focus on the mechanisms of psychedelics, and the others would need to involve clinical trials with human subjects. Those funds, set to be released in fiscal year 2024, totaled $1.5 million.
At a Senate committee hearing earlier in 2023, NIDA Director Nora Volkow told members that there’s emerging evidence that psychedelics carry “significant potential” as therapeutic treatments for certain mental health conditions, and it’s a topic of “great interest” for researchers.
In 2022, senators Brian Schatz (D-HI) and Cory Booker (D-NJ) pushed top federal officials to provide an update on research into the therapeutic potential of psychedelics, arguing that ongoing federal prohibition has stymied studies.
NIDA responded to the inquiry by saying that federal prohibition makes it more difficult to study the benefits of psychedelics, requiring researchers to jump through additional regulatory hoops. Volkow previously said that she personally hesitates to study Schedule I drugs because of those complications.
Volkow told Marijuana Moment in 2021 that researchers need to prioritize psychedelics research, as more people are likely to use them as they’re exposed to studies showing the therapeutic potential of the substances.
Congress was scheduled to hold its first-ever subcommittee hearing dedicated to veterans and mental health care in October, but the event was postponed.
Meanwhile, support appears to be growing at the federal level to expand psychedelic-assisted therapy to military veterans with post-traumatic stress disorder (PTSD) and other mental health conditions, although Department of Veterans Affairs (VA) officials have insisted on the need to proceed cautiously to avoid putting veterans at risk of further harm.
VA officials recently launched a new podcast about the future of veteran health care, with its first episode focused on the healing potential of psychedelics.
Congress was scheduled to hold its first-ever subcommittee hearing dedicated to veterans and mental health care in October, but the event was postponed as Republicans in the House scrambled to select a speaker.
A number of the subcommittee’s members—Republicans especially—have previoulsy expressed interest in psychedelics reform. Rep. Jack Bergman (R-MI), for example, is the co-founding member of the Congressional Psychedelics Advancing Therapies (PATH) Caucus, a bipartisan group relaunched in March.
Another member, Rep. Morgan Luttrell (R-TX), has publicly shared how treatment with ibogaine and 5-MeO-DMT “changed my life” and was “one of the greatest things that ever happened to me.” Earlier in 2023, he and several other GOP lawmakers spoke in favor of a bill to create a $75 million federal grant program to support research into the therapeutic potential of psychedelics for certain health conditions among active duty military service members.
And the House subcommittee’s chair, Rep. Mariannette Miller-Meeks (R-IA), led a roundtable during summer 2023 to discuss emerging therapies for PTSD and SUD.
Earlier this in 2023, House lawmakers passed a spending bill with a number of veteran-focused marijuana and psychedelics amendments. One would allow VA doctors to issue medical cannabis recommendations to former servicemembers, and the other would encourage research into the therapeutic potential of psychedelics.
California advocates are trying to qualify three separate psychedelics reform measures for the 2024 ballot.
In August, three bipartisan co-chairs of the Congressional Cannabis Caucus wrote to VA Secretary Denis McDonough expressing “deep concern” over a recent VA marijuana directive that continues to prohibit its doctors from making medical cannabis recommendations to veterans living in states where it’s legal.
Rep. Earl Blumenauer (D-OR), one of the authors of that letter, recently sent a separate letter to McDonough and Department of Defense (DoD) Secretary Lloyd Austin slamming their departments for perpetuating a “misguided denial of services” by recommending against the use of medical marijuana by veterans with PTSD.
VA and DoD “have a long history of claiming the best interest of our veterans and service-members only to deny the reality of medical marijuana as a key treatment option for those impacted by PTSD,” he wrote, referencing recently updated joint clinical practice guidelines that the departments released in July.
Oregon in 2020 legalized psilocybin therapy in addition to decriminalizing possession of all drugs. The state approved the first legal psilocybin service 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 in 2022.
California advocates are trying to qualify three separate psychedelics reform measures for the 2024 ballot. One, which would legalize the possession, sale and regulated therapeutic use of psilocybin, has already begun gathering signatures.
Another proposal would create a $5 billion state agency tasked with funding and promoting psychedelics research that it hopes will accelerate federal legalization of substances like psilocybin and ibogaine. And a third campaign has filed a prospective initiative to legalize psychedelics broadly for therapeutic and spiritual use with a doctor’s recommendation.
Image via City of Hillsboro, Oregon