Accelerating Safe Clinical Evaluation of Novel Treatments: Ibogaine for Better Outcomes in Opioid Use Disorder

Opioid use disorder (OUD) is a devastating condition affecting more than 5 million Americans and remains one of the most urgent public health crises in the United States. While existing treatments like buprenorphine, methadone, and naloxone help reduce death and poor health outcomes related to opioid use and opioid overdose, more than 75% of people with OUD do not receive treatment. Many people who do receive care still face high rates of treatment dropout and relapse. 

To expand limited treatment options for OUD, ARPA-H is exploring the promising new frontier of psychedelics and other rapid-acting neuroplastogen-based interventions, such as ketamine. These compounds may promote lasting, beneficial changes in brain function and mental health that can be useful in promoting recovery. One such compound, ibogaine, has shown early potential in anecdotal reports from medical clinics around the world, with patients reporting dramatic reductions in opioid cravings and withdrawal symptoms. Despite this promise, no active clinical trials with the required federal authorization currently exist to rigorously study ibogaine's safety and effectiveness for OUD in the United States—a critical gap that ARPA-H is now working to close. 

This effort is directly aligned with Executive Order 14401, Accelerating Medical Treatments for Serious Mental Illness and aims to support the development of ibogaine-based treatment for people with OUD at high risk of negative health outcomes. ARPA-H is calling on researchers, clinicians, and innovators across academia, industry, and government to help accelerate early-stage (Phase 1 and 2) clinical trials of ibogaine for OUD that prioritize patient safety and translation into Phase 3 testing. These trials represent a critical step toward generating the rigorous scientific evidence needed to evaluate ibogaine as a potentially transformative new treatment option.