ANZCTR - Registration

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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

Scientific title

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

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

N/A

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Opioid dependence

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Interventional

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.

Intervention code [1]

Treatment: Drugs

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.

Control group

Placebo

Outcomes

Primary outcome [1]

Plasma pharmacokinetics of ibogaine and its active metabolite

Timepoint [1]

predose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168h

Secondary outcome [1]

Safety

Timepoint [1]

- 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

Secondary outcome [2]

Tolerability

Timepoint [2]

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

Secondary outcome [3]

Pharmacodynamics

Timepoint [3]

- 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

Eligibility

Key inclusion criteria

Healthy volunteers, drug free, good general health, normal screening lab tests and ECG

Minimum age

20 Years

Maximum age

40 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Significant medical history, drug use

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

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.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer-generated random code

Masking / blinding

Blinded (masking used)

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

Intervention assignment

Parallel

Other design features

Phase

Phase 1

Type of endpoint/s

Pharmacokinetics / pharmacodynamics

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.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/05/2013

Actual

1/07/2013

Date of last participant enrolment

Anticipated

1/07/2013

Actual

15/09/2013

Date of last data collection

Anticipated

Actual

15/09/2013

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

PO Box 913
Dunedin 9054, NZ

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago

Address

PO Box 913
Dunedin 9054, NZ

Country

New Zealand

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Phytostan Enterprises, Inc.

Address [1]

925 De Maisonneuve Blvd. West, Suite 110
Montreal, Quebec H3A OA5

Country [1]

Canada

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health and Disability Ethics Committee

Ethics committee address [1]

1 The Terrace
PO Box 5013
Wellington 6145

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

11/02/2013

Ethics approval number [1]

NTY/12/04/031

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Paul Glue

Address

Psychological Medicine, Health Sciences Dunedin School of Medicine University of Otago
PO Box 913 Dunedin 9054

Country

New Zealand

Phone

64 3 470 3867

Fax

paul.glue@otago.ac.nz

Contact person for public queries

Name

Kira Garbe

Address

Psychological Medicine, Health Sciences Dunedin School of Medicine University of Otago
PO Box 913 Dunedin 9054

Country

New Zealand

Phone

64 3 470 9451

Fax

garki748@student.otago.ac.nz

Contact person for scientific queries

Name

Helen Winter

Address

School of Pharmacy, University of Otago
PO Box 913 Dunedin 9054

Country

New Zealand

Phone

64 3 479 7272

Fax

helen.winter@otago.ac.nz

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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Documents added manually

Documents added automatically