Safety of ibogaine administration in detoxification of opioid-dependent individuals: a descriptive open-label observational study.
Level 4 - case-series / case-control
Uncontrolled prospective open-label case series.
PubMed 33620733 · doi:10.1111/add.15448
What was done
In an open-label observational study at a Dutch university medical center, 14 patients with opioid use disorder who had failed standard care were converted to morphine-sulphate and administered a single oral dose of ibogaine-HCl (10 mg/kg). Patients were monitored for at least 24 hours for cardiac parameters (QTc interval, heart rate, blood pressure), cerebellar side effects via the Scale for the Assessment and Rating of Ataxia (SARA), and psychomimetic effects via the Delirium Observation Scale (DOS).
What was found
The average maximum QTc prolongation was 95 ms (range 29–146 ms), with 50% of subjects reaching a QTc of over 500 ms. In 6 of 14 participants, QTc prolongation above 450 ms lasted beyond 24 hours; no torsades de pointes were observed. Severe transient ataxia resulting in an inability to walk without support was seen in all 14 patients. Delirium Observation Scale scores remained below the diagnostic threshold, and 11 of 14 patients did not return to morphine within 24 hours.
Why it matters
This study provides systematic clinical data on ibogaine administration, demonstrating that while short-term withdrawal and psychomimetic effects were manageable, the drug frequently causes severe transient ataxia and pronounced, prolonged QTc prolongation requiring strict cardiac monitoring.
Limits
The study is limited by a very small sample size (n = 14) and an uncontrolled, open-label design without a comparator group. Efficacy and long-term abstinence outcomes beyond the acute monitoring period were not evaluated.
Cited by
- context Ibogaine causes QT interval prolongation for a short period of time.