FDA Greenlights First U.S. Trial of Ibogaine Derivative for Treating Alcohol Use Disorder

The Food and Drug Administration approved the first human clinical trial testing noribogaine hydrochloride, a derivative of ibogaine developed by drugmaker DemeRx NB, for the treatment of alcohol use disorder on Friday. The clinical trial will test the ibogaine derivative as a potential treatment for alcohol-use disorder. DemeRx’s drug is a metabolite of ibogaine.

President Donald Trump signed an executive order on April 18 aimed at fast-tracking psychedelic research and expanding access for people struggling with mental illness, easing legal restrictions on psychedelics like ibogaine. Days before the FDA's Friday action, Trump signed the executive order directing federal agencies to speed research and loosen restrictions on psychedelics.

The FDA awarded national priority vouchers to three companies developing psychedelic treatments for major depressive disorder and PTSD.

The agency awarded priority review vouchers to two companies studying psilocybin for hard-to-treat forms of depression. A third company received a priority review voucher from the FDA for methylone, a drug related to MDMA, for post-traumatic stress disorder. The priority review vouchers shorten FDA reviews from a period of months to weeks.

FDA Commissioner Marty Makary said in a press release: “These medications have the potential to address the nation’s mental health crisis. ” Last July, Health Secretary Robert F. Kennedy Jr. told members of Congress his department aimed to make psychedelics available for hard-to-treat psychiatric conditions within one year.

Podcast host Joe Rogan personally urged Trump to loosen restrictions on ibogaine. Joe Rogan texted Trump about the psychedelic ibogaine, and Trump responded: “Sounds great. Do you want FDA approval? Let’s do it.” Rogan learned about ibogaine from his friend Ed Clay, who runs retreats making use of it in Mexico.

Former Texas Gov. Rick Perry, former Sen. Kyrsten Sinema, and podcast host Joe Rogan have backed ibogaine. Tech billionaire Peter Thiel invested in AtaiBeckley, a company studying MDMA and other psychedelic compounds.

A neurologist and founder of DemeRx first began studying ibogaine as a treatment for cocaine addiction in the 1990s. The founder told The Associated Press: “Every grant proposal that I submitted to (the National Institute on Drug Abuse) was rejected. I couldn’t get that funding and that’s why ibogaine didn’t advance in the 1990s.”

A researcher at Stanford University led a landmark study on ibogaine. The researcher said to CNN: “It acts across multiple neurotransmitter systems,” noting that its effects more intense than other psychedelics, like PTSD. ” In a 2017 study, researchers administered a 12 mg/kg dose of ibogaine to 30 participants with opioid dependence and tracked their progress for a year.

One month after treatment in the 2017 study, half of the 30 participants reported no opioid use. At the 12-month mark, seven participants reported they had continued to stay off opioids. In another study in Mexico, 80% of people who received ibogaine treatment reported that it eliminated or sharply reduced their opioid withdrawal symptoms.

In the Mexico study, half of the participants said ibogaine reduced cravings. In the Mexico study, 30% of participants reported they never used opioids again. Researchers began examining ibogaine for its potential anti-addictive effects around the 1960s after anecdotal reports from heroin users in the US claimed it reduced cravings and eased withdrawal symptoms.

In France, ibogaine was sold for more than three decades as a stimulant and antidepressant until it was banned by the government in the 1960s. Ibogaine is typically taken in capsule form or as powdered root bark mixed with water. Federal authorities classified ibogaine as a Schedule I controlled substance in 1967.