The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has granted DemeRx and Atai Life Sciences bid to conduct clinical trials to study the effects of the psychedelic ibogaine as a treatment for people suffering from opioid addiction.
Ibogaine is a naturally occurring psychoactive compound derived from the bark of the West African shrub iboga. It has been used for centuries in some cultures for medicinal, ritual, and ceremonial purposes. Ibogaine has been found to be a life-saving treatment to those addicted to heroin and opioids, essentially eliminating symptoms of opioid withdrawal. The medicine also helps curb cravings over the long-term.
However, those seeking ibogaine treatment must travel to certain to treatment centers in certain countries where it is legal.
Dr. Deborah Mash, CEO of DemeRx, has conducted previous large studies on ibogaine for the treatment of opioid use disorder (OUD). “Not only were patients able to safely and successfully transition into sobriety, we found no evidence of additional abuse potential,” Mash said. “Given the limitation in currently available treatments, ibogaine represents an enormous leap forward for OUD sufferers.”
Atai has invested $22 million into DemeRx to help develop the treatment. The approval from MHRA will enable DemeRx to recruit participants in a Phase I/IIa clinical trial, first to study ibogaine in recreational drug uses, and second in people suffering from OUD. Before beginning the second trial, MHRA will evaluate safety data and nonclinical trial results.
A total of 110 participants will be recruited, including 30 recreational drug users for the first study and 80 opioid-dependents for the second.
“Our clinical trial authorization is a critical milestone,” Mash said. “Stage 1 of the study will provide assessment of safety through the evaluation of ibogaine’s potential adverse effects before we move to the proof-of-concept efficacy portion of our study in patients who seek to detoxify from opioids.”
