None listed
Conditions
Brief summary
Since 1962 a network of lay experimental drug users have reported that ibogaine at high doses decreases opioid withdrawal symptoms in opioid dependent subjects. It is likely that the majority of the effects of ibogaine in humans are produced by the metabolite noribogaine rather than ibogaine itself. The conversion of ibogaine into noribogaine is mainly via an enzyme called CYP2D6. This enzyme belongs to the cytochrome P450 family and is involved in the metabolism of many drugs in the body. The study aims to characterize conversion of ibogaine to noribogaine based on measures of CYP2D6 activity, using single low doses of ibogaine dosed to healthy volunteers.
Interventions
- 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
- 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.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers, drug free, good general health, normal screening lab tests and ECG
Exclusion criteria
Significant medical history, drug use
Outcome results
None listed