Indication-stratified mortality risk of ibogaine treatment under contemporary safety protocols: a multisite analysis of 19,071 patients and updated systematic review of fatalities
Abstract
<title>Abstract</title> <p>Ibogaine has shown early therapeutic promise for substance use disorders (SUD) and post-traumatic stress disorder in veterans, but concerns about treatment-associated cardiac arrhythmia and death have constrained clinical development. Whether this risk is uniform across indications or concentrated in specific populations is unknown. We conducted a retrospective multisite study of 19,071 patients treated under established safety guidelines at 11 international clinics, with an updated systematic review of ibogaine-associated fatalities. Six deaths occurred within 72 hours, all among patients treated for opioid use disorder (6/10,382), with none among 8,689 non-SUD patients. This was mirrored in the review, where 41/44 fatalities with known indication involved SUD, predominantly opioid detoxification (P=1.6×10⁻⁹). The absolute rate represents a lower bound, given voluntary participation and non-adjudicated deaths; sensitivity analysis showed the conclusion robust to plausible unobserved deaths at non-participating clinics. These findings indicate that ibogaine-associated mortality is largely confined to opioid detoxification and rare in non-SUD indications.</p>
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