US advances first gov-funded trials of psychedelic drug ibogaine for addiction

FDA seeks public feedback on trial design and safety oversight by November 20 HHS-backed studies will examine opioid addiction and PTSD Heart risks remain the key hurdle to broader use - expert (Adds expert comments in paragraphs 5 and 8) By Kamal Choudhury Oct 5 (Reuters) — US health officials are advancing the first government-funded clinical trials of the psychedelic drug ibogaine to treat opioid addiction and post-traumatic stress disorder, the FDA said on Monday, as it sought public feedback on safety rules for the studies.

The initiative follows an April executive order by President Donald Trump, dedicating $50 million to the federal ibogaine research, as well as recent calls by experts and veterans for strict safety standards on psychedelic treatments. The Food and Drug Administration said it has opened a public docket seeking feedback on trial design, dose selection, patient eligibility, safety monitoring, study-stopping rules and oversight by November 20. "This is the most important regulatory signal ibogaine has received in decades," said Tom Feegel, CEO of Beond, a Mexico-based ibogaine treatment provider.

The Department of Health and Human Services is funding early-stage trials of ibogaine through the Advanced Research Projects Agency for Health and the National Institute on Drug Abuse, a federal notice showed. The FDA has previously warned that the drug carries severe health risks, including life-threatening irregular heart rhythms and potential brain toxicity. Ibogaine, a compound found in the roots of the African shrub iboga, is classified as an illegal Schedule I controlled substance under US law. "Cardiac safety is not a footnote...

it is the central challenge researchers have to solve before this treatment can responsibly reach the people who need it," said Betty Aldworth, co-executive director of the Multidisciplinary Association for Psychedelic Studies. com;)