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.

The study, registered on ANZCTR with registration number ACTRN12613000324718, focuses on individuals with opioid dependence. Cohort A receives placebo, while Cohort B is given once daily oral doses of paroxetine to induce a CYP2D6 poor metabolizer phenotype. All participants receive a single oral dose of ibogaine (20mg) on Day 8.

Various outcomes, including plasma pharmacokinetics of ibogaine, safety, tolerability, and pharmacodynamics, are assessed. The primary objective is to characterise ibogaine to noribogaine conversion based on CYP2D6 activity. The trial, approved by the Southern Health and Disability Ethics Committee, University of Otago, New Zealand, commenced enrolment on July 1, 2013, and completed on September 15, 2013.

Topic Healthy Subjects
Compound Ibogaine Placebo
Country New Zealand
Visit trial
Status Completed
Results Published No
Start date 01 July 2013
End date 15 September 2013
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 21
Sex All
Age 20- 40
Therapy No

Trial Details

- Cohort B will consist of volunteers who receive once daily oral doses of paroxetine capsules (Days 2 to 3- paroxetine 10mg and Days 4 to 15- paroxetine 20mg) to induce a CYP2D6 poor metabolizer phenotype. - Subjects will recieve a single oral dose of ibogaine 20mg on Day 8. Ibogaine will be given open label. - All subjects will also receive a single oral dose of dextromethorphan 30mg on Days 1 and 7 to determine their in vivo CYP2D6 phenotype. - All days mentioned in dosing are inclusive of the days listed above.

NCT Number ACTRN12613000324718

Sponsors & Collaborators

University of Otago
The University of Otago (specifically the Dunedin School of Medicine) is associated with psychedelic research but doesn't yet have a full profile.

Data attribution

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