Start
Completion

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

CompletedRegisteredANZCTR

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

Details

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).

Topics:Healthy Volunteers

Registry

Registry linkACTRN12613000324718