The Efficacy of Ibogaine in the Treatment of Addiction; an open label, single fixed dose pilot-study of the efficacy of ibogaine in opioid-dependent subjects
Open-label, single-arm Phase II pilot study (n=12) assessing a single fixed oral dose of ibogaine for reducing craving and opioid use in opioid-dependent patients with neuroimaging and electrophysiological secondary measures.
Detailed Description
Open-label, non-randomised, single-site Phase II pilot assessing the effects of one fixed oral dose of ibogaine in adults with opioid dependence; primary outcomes were relapse and subjective craving over six months.
Secondary outcomes included changes in brain activity measured by event related potentials (EEG) and functional MRI as markers of cue responsivity and cognitive processes related to craving; follow-ups occurred at 2, 4, 8, 12 and 24 weeks.
Safety evaluation focused on acute in‑hospital monitoring during opioid withdrawal and a six‑month post‑treatment safety assessment, with exclusion criteria targeting cardiac risk, severe psychiatric illness, pregnancy and interacting medications.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
Ibogaine single dose
experimentalOpen-label single fixed oral dose of ibogaine administered to opioid-dependent patients (single arm).
Interventions
- Ibogainevia Oral• single dose• 1 doses total
Oral powder formulation; fixed single dose (dose not specified in registry document).
Participants
Inclusion Criteria
- Males or females 23 to 60 years of age; currently dependent on opiate narcotics (DSM‑IV 304.00).
- Desire for detoxification and lasting abstinence.
- Failure of intensive treatment as usual.
- Willingness and motivation to comply with study procedures and provide written informed consent.
Exclusion Criteria
- Cardiac illness (history of ventricular fibrillation, long QT syndrome, syncope) or QTc > 500 ms on screening ECG.
- Diagnosis of schizophrenia or history of psychotic symptoms; severe major depressive disorder.
- Homelessness.
- Pregnancy.
- Actively suicidal.
- Any clinically significant chronic or unstable cardiac, renal or other medical condition.
- Gastrointestinal disorders interfering with absorption (e.g., ulcers, regional enteritis, GI bleeding) or liver enzymes >4× normal.
- Absence of opiates and/or methadone on urine test at screening.
- Concomitant medications that severely interfere with ibogaine (antiepileptics, neuroleptics, antidepressants, QT‑prolonging drugs, strong CYP2D6 interactors).
- Recent exposure to drugs with major organ toxicity within 1 month or participation in another investigational trial within 6 months.
Study Details
- StatusCompleted
- PhasePhase II
- Typeinterventional
- DesignNon-randomized
- Target Enrollment12 participants
- TimelineStart: 2014-11-10End: 2021-04-30
- Compound
- Topic