This randomised, double-blind, placebo-controlled trial (n=24) investigates the role of CYP2D6 in the pharmacokinetics of ibogaine (20mg) in healthy volunteers.
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).
Paroxetine induction to create CYP2D6 poor-metaboliser phenotype; single open-label ibogaine dose on Day 8.
Paroxetine 10 mg Days 2–3 then 20 mg Days 4–15 (oral, once daily).
Open-label ibogaine on Day 8.
Dextromethorphan 30 mg on Days 1 and 7 to phenotype CYP2D6.
Placebo capsules matching paroxetine; single open-label ibogaine dose on Day 8.
Identical-appearing placebo capsules Days 2–15.
Open-label ibogaine on Day 8.
Dextromethorphan 30 mg on Days 1 and 7 to phenotype CYP2D6.