Clinical TrialHealthy VolunteersIbogaineIbogaineCompleted

The role of CYP2D6 in the pharmacokinetics of ibogaine in healthy volunteers

This randomised, double-blind, placebo-controlled trial (n=24) investigates the role of CYP2D6 in the pharmacokinetics of ibogaine (20mg) in healthy volunteers.

Target Enrollment
21 participants
Study Type
Phase I interventional
Design
Randomized, single Blind

Detailed Description

Phase I, parallel randomised study in healthy volunteers comparing paroxetine induction of CYP2D6 poor-metaboliser phenotype versus matched placebo; ibogaine 20 mg given open-label on Day 8.

All participants receive dextromethorphan 30 mg on Days 1 and 7 to phenotype CYP2D6; paroxetine dosing is 10 mg on Days 2–3 then 20 mg on Days 4–15 in the active cohort. Outcomes include plasma pharmacokinetics of ibogaine and its active metabolite and safety monitoring (labs, vitals, serial cardiovascular measures up to 168 h post-dose).

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Paroxetine + ibogaine

experimental

Paroxetine induction to create CYP2D6 poor-metaboliser phenotype; single open-label ibogaine dose on Day 8.

Interventions

  • Compound20 mg
    via Oral• daily

    Paroxetine 10 mg Days 2–3 then 20 mg Days 4–15 (oral, once daily).

  • Ibogaine20 mg
    via Oral• single dose

    Open-label ibogaine on Day 8.

  • Compound30 mg
    via Oral• single dose• 2 doses total

    Dextromethorphan 30 mg on Days 1 and 7 to phenotype CYP2D6.

Placebo + ibogaine

inactive

Placebo capsules matching paroxetine; single open-label ibogaine dose on Day 8.

Interventions

  • Compound
    via Oral• daily

    Identical-appearing placebo capsules Days 2–15.

  • Ibogaine20 mg
    via Oral• single dose

    Open-label ibogaine on Day 8.

  • Compound30 mg
    via Oral• single dose• 2 doses total

    Dextromethorphan 30 mg on Days 1 and 7 to phenotype CYP2D6.

Participants

Ages
20 – 40
Sexes
Male & Female

Inclusion Criteria

  • Healthy volunteers; drug free; good general health; normal screening laboratory tests and ECG.

Exclusion Criteria

  • Significant medical history; drug use.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment21 participants
  • Timeline
    Start: 2013-07-01
    End: 2013-09-15
  • Compounds
    IbogaineIbogaine
  • Topic
    Healthy Volunteers

Locations

Unknown facility — Australia

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