Clinical TrialAlcohol Use Disorder (AUD)IbogainePlaceboCompleted

Ibogaine in the Treatment of Alcoholism: a Randomized, Double-blind, Placebo-controlled, Escalating-dose, Phase 2 Trial

The aim of the present study is to evaluate the safety, tolerability and efficacy of increasing doses of ibogaine in 12 alcoholic patients.

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Target Enrollment
9 participants
Study Type
Phase II interventional
Design
Randomized

Detailed Description

This phase II, escalating-dose study tests oral ibogaine in people with alcohol use disorder; an initial open-label lead-in (first 3 participants, 20–400 mg) precedes a randomized placebo-controlled allocation for the remaining participants.

Participants are hospitalised for 20 days, receive three escalating doses (examples: 240, 320, 400 mg) and are followed at 7, 14, 21 days and 1, 3, 6, 12 months for alcohol and other drug use and safety monitoring.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

Ibogaine

experimental

Escalating oral ibogaine dosing (240–400 mg) with initial open-label lead-in then randomized dosing groups.

Interventions

  • Ibogaine240 - 400 mg
    via Oral• three doses• 3 doses total

    First 3 patients open-label 20–400 mg; subsequent participants randomised to 240, 320 or 400 mg.

Placebo

inactive

Placebo control for randomized portion.

Interventions

  • Placebo
    via Oral• three doses• 3 doses total

    Placebo administered in randomized groups for days corresponding to dosing schedule.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Literate people
  • Diagnosis of alcoholism assessed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-V)
  • History of at least two previous failed treatments for alcoholism (with drug use and / or psychotherapy)
  • Signing the Free and Informed Consent Form.

Exclusion Criteria

  • Presence of any psychiatric diagnosis (excluding alcohol / tobacco / nicotine abuse / dependence) assessed by the SCID-V
  • Presence of clinical disease (especially cardiovascular and hepatic diseases), based on interview, physical and laboratory examination (hemogram and electrocardiogram, ECG)
  • Absence of family or personal history of bipolar disorder and psychotic disorders
  • Absence of recent symptoms of hypomania, mania or psychosis
  • Non-literate people
  • Pregnant or lactating women
  • Recent use of illicit drugs (confirmed by examination in urine).

Study Protocol, Arms & Participants

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Study Details

Study Team

Locations

Ribeirão Preto Medical School — Ribeirão Preto, São Paulo, Brazil

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