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Trial registered on ANZCTR
Registration number
ACTRN12613000324718
Ethics application status
Approved
Date submitted
11/03/2013
Date registered
22/03/2013
Date last updated
7/11/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
CYP2D6 and the pharmacokinetics of ibogaine
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Scientific title
The role of CYP2D6 in the pharmacokinetics of ibogaine in healthy volunteers
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Secondary ID [1]
282110
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None
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Universal Trial Number (UTN)
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Trial acronym
N/A
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Opioid dependence
288605
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Condition category
Condition code
Mental Health
288937
288937
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
- 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.
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Intervention code [1]
286711
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Treatment: Drugs
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Comparator / control treatment
- Cohort A will consist of volunteers who receive once daily oral doses of ‘paroxetine-placebo capsules’ from Days 2 to 15.
- Subjects will recieve a single open-label oral dose of ibogaine 20mg on Day 8.
- 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.
- Placebo capsules will be identical in appearance to those of active capsules, however will not contain paroxetine.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Plasma pharmacokinetics of ibogaine and its active metabolite
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Assessment method [1]
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Timepoint [1]
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predose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168h
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Secondary outcome [1]
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Safety
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Assessment method [1]
301663
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Timepoint [1]
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- Safety laboratory tests: CBC, electrolytes, dipstick urine at screening and study end.
- vital signs (blood pressure, heart rate) (Day 1: 0, 2, 4h; Day 8: 0, 2, 4, 12h, 24, 48, 72, 96, 120, 144, 168h
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Secondary outcome [2]
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Tolerability
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Assessment method [2]
301874
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Timepoint [2]
301874
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Reported adverse events throughout study.
100mm visual analogue scales measuring “sleepy”, “energetic”, “nausea”, “anxious”, “calm” at Day 1: 0, 2, 4h; Day 8: 0, 2, 4, 12, 24, 48, 72, 96, 120, 144 and 168h
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Secondary outcome [3]
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Pharmacodynamics
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Assessment method [3]
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Timepoint [3]
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- Psychomotor performance using tests of memory and attention, including simple and choice reaction time. (Day 1: 0, 2, 4h; Day 8: 0, 2, 4, 12h; 24h (Day 9); 168h (Day 15)
- Central (tympanic) temperature (Day 1: 0, 2, 4h; Day 8: 0, 2, 4, 12h; 24h (Day 9); 168h (Day 15)
- Pupillometry to assess pupil diameter, average speed of constriction and dilation to a light flash (Day 1: 0, 2, 4h; Day 8: 0, 1, 2, 3, 4, 6, 12h; 24h (Day 9); 168h (Day 15)
- Computerised tests of memory and attention. These tests assess a range of functions, including memory, reaction time, and measures of attention, Days 1, 7, 8, 9, 15 at approximately 10AM
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Eligibility
Key inclusion criteria
Healthy volunteers, drug free, good general health, normal screening lab tests and ECG
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Minimum age
20
Years
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Maximum age
40
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Significant medical history, drug use
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization will be based on a computer-generated random code. All study staff will be blinded to treatment allocation. Allocation concealment will be managed useing numbered containers. Subjects will be allocated the next available subject number.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random code
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Pharmacokinetics / pharmacodynamics
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Statistical methods / analysis
Comparisons of ibogaine PK data between placebo and paroxetine cohorts will be made using independent t-tests or Mann-Whitney test, as appropriate. Population PK and multivariate linear regression techniques will be used to explore the relationship(s) between PK parameters and pharmacodynamic parameters.
Pharmacodynamic variables will be summarised and graphed by Cohort, using means or medians with standard deviations or inter-quartile ranges as appropriate.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/05/2013
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Actual
1/07/2013
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Date of last participant enrolment
Anticipated
1/07/2013
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Actual
15/09/2013
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Date of last data collection
Anticipated
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Actual
15/09/2013
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Sample size
Target
24
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Accrual to date
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Final
21
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Recruitment outside Australia
Country [1]
4907
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New Zealand
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State/province [1]
4907
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Otago
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Address [1]
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PO Box 913
Dunedin 9054, NZ
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Country [1]
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New Zealand
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Primary sponsor type
University
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Name
University of Otago
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Address
PO Box 913
Dunedin 9054, NZ
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Country
New Zealand
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Phytostan Enterprises, Inc.
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Address [1]
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925 De Maisonneuve Blvd. West, Suite 110
Montreal, Quebec H3A OA5
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Country [1]
285668
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Canada
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Southern Health and Disability Ethics Committee
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Ethics committee address [1]
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1 The Terrace PO Box 5013 Wellington 6145
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
288940
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Approval date [1]
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11/02/2013
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Ethics approval number [1]
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NTY/12/04/031
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Paul Glue
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Address
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Psychological Medicine, Health Sciences Dunedin School of Medicine University of Otago
PO Box 913 Dunedin 9054
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Country
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New Zealand
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Phone
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64 3 470 3867
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Fax
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Email
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paul.glue@otago.ac.nz
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Contact person for public queries
Name
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Kira Garbe
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Address
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Psychological Medicine, Health Sciences Dunedin School of Medicine University of Otago
PO Box 913 Dunedin 9054
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Country
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New Zealand
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Phone
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64 3 470 9451
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Fax
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Email
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garki748@student.otago.ac.nz
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Contact person for scientific queries
Name
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Helen Winter
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Address
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School of Pharmacy, University of Otago
PO Box 913 Dunedin 9054
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Country
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New Zealand
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Phone
38428
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64 3 479 7272
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Fax
38428
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Email
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helen.winter@otago.ac.nz
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Influence of CYP2D6 activity on the pharmacokinetics and pharmacodynamics of a single 20 mg dose of ibogaine in healthy volunteers.
2015
https://dx.doi.org/10.1002/jcph.471
Embase
Effects of low dose ibogaine on subjective mood state and psychological performance.
2016
https://dx.doi.org/10.1016/j.jep.2016.05.022
N.B. These documents automatically identified may not have been verified by the study sponsor.
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