FDA Wants to Know How to Test Ibogaine on Humans. You Have Until Nov. 20 to Tell It.

The most useful thing anyone can do with ibogaine this month is not take it. It is to write to the FDA. On October 5 the agency opened a request for information on how to design early-phase ibogaine trials, with comments due Friday, November 20, under docket FDA-2026-N-10429 at regulations.gov.

If you have heard people in recovery talk about ibogaine, you have heard the promise: one dose in a clinic abroad and the opioid craving goes quiet. The FDA’s framing is blunter. Michael Davis, who directs the Center for Drug Evaluation and Research, said: “With ibogaine, there are important scientific questions as well as serious safety concerns.” The safety concern is mostly the heart, and the request asks for input on monitoring cardiac and neurologic adverse events.

The public comment period is the only part of this process where a person with lived experience, a clinic, or a family can put a fact on the record, and it is open for four more weeks.

The request covers four areas: which patient groups to enroll; dose selection and escalation, including a starting dose supported by existing data and not above 10 mg/kg; safety monitoring; and ethics, including informed consent and independent safety oversight. The release says HHS is prioritizing two groups for federally supported research, adults with opioid use disorder and adults with PTSD. It also notes that NIDA is funding ibogaine research for opioid use disorder, and that the FDA has allowed an early-phase study of noribogaine, a compound the body makes from ibogaine, as a potential treatment for alcohol use disorder.

None of that makes ibogaine available. This is a request for information about running a first-stage safety study. Nothing in it approves a treatment, and clinics selling ibogaine today are operating outside this process, in some cases in other countries, with no US oversight.

If you run a program, you can comment: describe what follow-up care your patients need after a high-risk, one-time treatment, because the trial design that gets written now will decide whether that follow-up is built in or left to you. If you are a person who has been through it, or lost someone who tried, your account is evidence, and the docket is public.

The people who take ibogaine are usually people who have been through everything else. Let the trial be designed by someone who knows that.