NIH funds ibogaine study for opioid addiction with heart safety focus

NIH funds ibogaine study for opioid addiction

The National Institute on Drug Abuse (NIDA) has awarded approximately $2.3 million to Brigham and Women's Hospital in Boston to investigate the safety of ibogaine for individuals with opioid use disorder, according to federal grant records. This study aims to address the significant heart risks associated with ibogaine, a psychedelic compound derived from the African iboga shrub.

Study design and heart safety measures

The research, led by Dr. Joji Suzuki of Mass General Brigham, is structured to prioritize heart safety. The study will classify any dose of ibogaine that extends the heart's electrical recovery time beyond a set threshold as too toxic. The trial will begin with a Phase 1 study involving healthy volunteers who will receive single, increasing doses of pharmaceutical-grade ibogaine to determine the maximum tolerable dose. Participants will be monitored in a hospital setting with ECG equipment, similar to protocols for certain heart rhythm medications.

If successful, the study will progress to a Phase 2a trial involving individuals with opioid use disorder who have not adequately responded to buprenorphine. This phase will compare different doses and will include only participants who have never used ibogaine before. The study's timeline is contingent on FDA approval at each stage.

Regulatory context and broader interest

Ibogaine remains a Schedule I drug in the United States, with no FDA-approved medical use. Despite this, interest in ibogaine is increasing, partly due to an April executive order promoting psychedelic research and new state funding initiatives. The FDA recently allowed a U.S. study of noribogaine, ibogaine's main metabolite, for alcohol use disorder, marking the first U.S. clinical study of an ibogaine derivative.

Why it matters

The study's focus on heart safety is crucial, as ibogaine can prolong the QT interval, potentially leading to dangerous heart rhythms and sudden cardiac arrest. This risk is particularly significant for individuals with a history of heart disease or those taking other medications that affect heart rhythm, such as methadone. The research could pave the way for safer use of ibogaine in treating opioid addiction, but proven treatments like buprenorphine and methadone remain the standard of care.

Considerations for families and individuals

Many Americans seeking ibogaine treatment travel to unregulated clinics abroad, where safety protocols vary. Addiction specialists caution against replacing established medications with ibogaine, as detoxing from proven therapies can increase overdose risk. Families are advised to consult clinicians about adjusting current treatments before considering experimental options. Emergency care is recommended for anyone experiencing adverse symptoms after taking ibogaine.

The next step for the study is obtaining FDA clearance for the investigational new drug application. Until the trials are completed, the potential benefits of ibogaine must be weighed against its heart risks.