Safety of ibogaine administration in detoxification of opioid dependent individuals: a descriptive open-label observational study.

Abstract

BACKGROUND AND AIMS\nIbogaine is an indole alkaloid used in rituals of the Bwiti tribes of Africa. It is also used in non-medical settings to treat addiction. However, ibogaine has been linked to several deaths, mostly due to cardiac events called torsades des pointes preceded by QTc prolongation as well as other safety concerns. This study aimed to evaluate the cardiac, cerebellar and psychomimetic safety of ibogaine in patients with opioid use disorder.\n\n\nDESIGN\nA descriptive open-label observational study.\n\n\nSETTING\nDepartment of psychiatry in university medical center, The Netherlands.\n\n\nPARTICIPANTS\nPatients with opioid use disorder (n=14) on opioid maintenance treatment with a lasting wish for abstinence, who failed to reach abstinence with standard care.\n\n\nINTERVENTION AND MEASUREMENTS\nAfter conversion to morphine-sulphate, a single dose of ibogaine-HCl 10mg/kg was administered and patients were monitored at regular intervals for at least 24 hours assessing QTc, blood pressure and heart rate, Scale for the Assessment and Rating of Ataxia (SARA, to assess cerebellar side effects) and the Delirium Observation Scale (DOS, to assess psychomimetic effects).\n\n\nFINDINGS\nThe maximum QTc prolongation was on average 100ms (range 40-168ms). Fifty percent of subjects reached a QTc of over 500ms during the observation period. In six out 14 subjects prolongation above 450ms lasted beyond 24 hours after ingestion of ibogaine. No torsades des pointes were observed. Severe transient ataxia with inability to walk without support was seen in all patients. Withdrawal and psychomimetic effects were mostly well-tolerated and manageable (11/14 did not return to morphine within 24 hours, DOS scores remained below threshold).\n\n\nCONCLUSIONS\nAn open-label observation study found that ibogaine treatment of patients with opioid use disorder can induce a clinically relevant but reversible QTc prolongation, bradycardia, and severe ataxia.