The FDA is asking the public to weigh in on how ibogaine should be tested in people, and its starting proposal is strict. Early studies would take place in an inpatient unit equipped to handle a life-threatening heart rhythm, with continuous heart monitoring that could last up to 36 hours after a single dose.
The proposal matters for people with opioid addiction, PTSD, and other hard-to-treat conditions who have heard about ibogaine through news coverage, state funding, or clinics abroad. It sets out in detail how FDA believes the drug's heart risks should be managed before any benefit can be measured.