This open-label, single fixed dose pilot-study trial (n=12) aimed to investigate the efficacy of ibogaine in treating opioid dependence.
Conducted by Radboud UMC in the Netherlands, the study assessed the short and long-term effects of a single administration of ibogaine on craving and substance use over a six-month follow-up period. Secondary objectives included examining the effects of ibogaine on cognitive processes linked to craving, evaluating dropout rates during treatment, and assessing safety during acute in-hospital opioid withdrawal and post-treatment.
Participants, aged 23 to 60, were opioid-dependent individuals wishing for detoxification and lasting abstinence. The trial found promising results in reducing relapse and subjective craving after detoxification. However, it excluded patients with certain medical conditions, including cardiac illness and severe major depressive disorder, as well as pregnant individuals and those actively suicidal. The trial received authorisation from the Competent Authority in the Netherlands and ethical approval on November 10, 2014.
Trial Details
This open-label trial (n=12) investigated the efficacy of ibogaine in treating opioid dependence, assessing its effects on craving and substance use over a six-month period. Conducted by Radboud UMC in the Netherlands, it found promising results in reducing relapse and subjective craving after detoxification.NCT Number 2014-000354-11
Sponsors & Collaborators
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Papers
The pharmacokinetics and pharmacodynamics of ibogaine in opioid use disorder patientsThis pharmacokinetic study (n=14) on ibogaine (700mg/70kg) for opioid use disorder (OUD) finds significant variability in ibogaine clearance, strongly correlated with CYP2D6 genotype. Ibogaine plasma concentrations correlate with QTc prolongation and cerebellar effects, while neither ibogaine nor noribogaine correlate with the severity of opioid withdrawal symptoms.
Safety of ibogaine administration in detoxification of opioid dependent individuals: a descriptive open-label observational study
This open-label observational study (n=14) investigated the safety profile of ibogaine (700mg/70kg) for patients with opioid use disorder who were undergoing acute opioid withdrawal. Although patients experienced mild withdrawal symptoms and transient well-tolerated psychomimetic effects, they exhibited abnormal patterns in heart rhythm that constituted an adverse level of cardiovascular risk. This study indicates that even a low-dose administration of ibogaine requires strict cardiac monitoring, and should be restricted to well-controlled settings.