Backed by $11M NIDA Grant, Harvard Moves Forward on Ibogaine for Opioid Use Disorder Research

Yesterday, various U.S. federal bodies announced psychedelics-related actions, as we covered. 

That news included a funding award from the National Institute on Drug Abuse (NIDA) to support a multi-phase ibogaine for opioid use disorder (OUD) project at Harvard. The Advanced Research Projects Agency for Health (ARPA-H) also announced a funding opportunity related to developing ibogaine for OUD, which closes in three weeks.

To learn more about the Harvard project, we spoke to the project’s principal investigator, Joji Suzuki, who works in the Department of Psychiatry at Mass General Brigham and is an Associate Professor of Psychiatry at Harvard Medical School.

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The funding comes by way of a UG3/UH3 grant worth up to around $11 million, with the goal of securing investigational new drug (IND) clearance before conducting a Phase I study and potentially a Phase IIa. At present, an initial $2.3M tranche has been released.

Suzuki’s group is known for exploring innovative potential substance use disorder (SUD) therapeutics like GLP-1 agonists and psychedelic drugs. Now, his lab will be leading the charge in ibogaine research, and could become the first to secure that IND clearance to study ibogaine in the U.S.

Getting that green light has been an elusive goal for ibogaine researchers, drug developers, and advocates alike, with only noribogaine—the drug’s primary active metabolite—cleared for domestic trials. (That clearance was handed to DemeRx earlier this year, around the signing of the psychedelics executive order, and covers a protocol that would see the metabolite trialled at lower doses for a week or so.)

Suzuki et al., meanwhile, will seek FDA clearance to trial ibogaine itself in a more familiar protocol that features higher doses, and ultimately hopes to reach a Phase II study in patients with opioid use disorder (OUD).

Speaking to Psychedelic Alpha, Suzuki was upbeat about the funding, but clear-eyed about the work that remains to be done.

As aforementioned, the goal is tripartite: Secure an IND, complete a Phase I study, and proceed to Phase II, should the safety profile of the intervention allow.

That’s the plan, at least, but it all depends on reaching agreement with FDA on each ...