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Trial registered on ANZCTR
Registration number
ACTRN12613001064796
Ethics application status
Approved
Date submitted
19/09/2013
Date registered
24/09/2013
Date last updated
28/07/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
Noribogaine Therapy for Relief of Opioid withdrawal, Phase 1B
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Scientific title
A Phase 1B, Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Noribogaine in Opioid Dependent Participants Seeking to Discontinue Methadone Opioid Substitution Treatment (OST)
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Secondary ID [1]
282995
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ZPS-513 (Protocol ID)
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Universal Trial Number (UTN)
U1111-1142-3953
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Trial acronym
NITROW-P1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Symptoms of opioid withdrawal
289822
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Condition category
Condition code
Mental Health
290176
290176
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0
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Administration of a single oral dose of noribogaine. It is planned that the first dose cohort will receive 60mg, the second cohort 120mg and the third cohort 180mg. Noribogaine will be administered under supervision at the study site.
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Intervention code [1]
287711
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Treatment: Drugs
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Comparator / control treatment
Each study cohort will consist of 9 participants - six randomised to noribogaine and three randomised to placebo (microcrystalline cellulose capsule).
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Evaluate the safety and tolerability of noribogaine in opioid dependent participants seeking to discontinue their methadone OST. This will be evaluated by adverse events, vitals signs, ECGs, laboratory tests, physical exam, ocular exam and C-SSRS.
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Assessment method [1]
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Timepoint [1]
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Day 7
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Primary outcome [2]
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Evaluate the pharmacokinetics of noribogaine in opioid dependent participants seeking to discontinue their methadone OST. The following pharmacokinetic parameters will be derived for noribogaine: Cmax, AUCT, AUC0-inf8), half-life, Tmax, Vd/F and CL/F. Urine will be assayed for noribogaine and its metabolites.
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Assessment method [2]
290560
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Timepoint [2]
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Day 7
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Secondary outcome [1]
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Ability to discontinue methadone OST (Endpoint is time to resumption of OST)
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Assessment method [1]
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Timepoint [1]
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Day 7
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Secondary outcome [2]
304112
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Withdrawal Suppression as measured by SOWS, OOWS, COWS, Mood VAS, ASI and PRS rating scales
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Assessment method [2]
304112
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Timepoint [2]
304112
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Day 7
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Secondary outcome [3]
304113
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Noribogaine and methadone pharmacodynamics, as measured by oximetry, capnography and pupillometry
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Assessment method [3]
304113
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Timepoint [3]
304113
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Day 7
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Secondary outcome [4]
304117
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Methadone Pharmacokinetic Analysis - the following pharmacokinetic parameters will be derived for methadone: Cmax, AUCO24, AUC, AUC0 inf, and half-life, Tmax, Vd/F and CL/F.
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Assessment method [4]
304117
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Timepoint [4]
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Day 1
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Eligibility
Key inclusion criteria
The main inclusion criteria are opioid dependent male and female adults who provide written consent and are on stable doses of methadone through the OST programme. Participants cannot have any other major illnesses or disorders and must be willing to comply with the restrictions of the study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria include current treatment for hepatitis C; HIV positive; DSM IV Axis I diagnosis of psychotic disorders; specified excluded concomitant medications; DSM IV criteria for dependence on substances other than opioids, caffeine, and/or nicotine.
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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)
After obtaining consent and confirming eligibility, the participant will be enrolled in the study. Randomisation will occur prior to administration of Study Drug on Day 1. Study drug will be prepared for each participant by pharmacy staff, according to the randomisation code. All clinical staff will remain blinded. Individual randomisation envelopes will be provided in case the identity of study drug administered to a participant needs to be known.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by computer
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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
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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
Safety/efficacy
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Statistical methods / analysis
This is a Phase 1B study and therefore an industry- standard sample of 9 participants per dose cohort has been chosen.
Participant demographic and presenting clinical features will be summarized using standard descriptive statistics, including means, medians, ranges, standard deviations, and frequencies and percentages as appropriate. These summaries will be presented by randomized group.
Adverse events and serious adverse events collected after study drug administration will be listed individually and be summarised by relatedness and severity classes by randomised group. Other safety variables, including laboratory and ophthalmological assessments, C-SSRS responses, vital signs, and ECG data will be summarized at each sampling time after study drug administration for each dose group and placebo, using means, medians, standard deviations and ranges.
Data listings and summaries of the pharmacokinetic parameters by dose level will be presented for the noribogaine PkP and methadone PkP. Descriptive statistics including means, medians, standard deviations and ranges or frequencies and percentages) will be used to summarize these. The pharmacokinetic parameters (Cmax, AUC(0-24), AUC(T), AUC(8), half-life, Tmax, Vd/F and CL/F ) will be estimated using standard non-compartmental models from the noribogaine and methadone plasma concentration data. Cmax, AUC(0-24), AUC(T) and AUC(8) parameters will be dose adjusted (divided by the dose of each group) and compared between groups using ANOVA or Kruskall-Wallis non-parametric ANOVAs as appropriate. These comparisons test the null hypothesis of dose proportionality for each parameter.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/10/2013
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Actual
14/10/2013
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Date of last participant enrolment
Anticipated
16/05/2014
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Actual
13/05/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
27
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5291
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New Zealand
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State/province [1]
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Otago
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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DemeRx Inc
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Address [1]
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DemeRx, Inc, 305 S. Andrews Avenue, Suite 515 Fort Lauderdale, FL 33301 USA
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Country [1]
287775
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
DemeRx Inc
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Address
DemeRx, Inc, 305 S. Andrews Avenue, Suite 515 Fort Lauderdale, FL 33301 USA
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Country
United States of America
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Secondary sponsor category [1]
286502
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None
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Name [1]
286502
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Address [1]
286502
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Country [1]
286502
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289725
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Southern health and Disability Ethics Committee
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Ethics committee address [1]
289725
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Health and Disability Ethics Committees
1 The Terrace
PO Box 5013
Wellington
6011
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Ethics committee country [1]
289725
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New Zealand
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Date submitted for ethics approval [1]
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06/08/2013
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Approval date [1]
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27/08/2013
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Ethics approval number [1]
289725
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13/STH/100
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Summary
Brief summary
This is a research study to evaluate the safety, tolerability and effects of noribogaine, an atypical opioid. We will also be looking at its effects on opioid withdrawal symptoms in opioid dependent people who are maintained on stable doses of methadone and who want to stop taking methadone.
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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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Department of Psychological Medicine
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin 9016
New Zealand
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Country
42082
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New Zealand
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Phone
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+64 21 243 3372
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Linda Folland
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Address
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Zenith Technology Ltd
156 Frederick Street (P O Box 1777)
Dunedin 9016
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Country
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New Zealand
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Phone
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+64 3 477 9669
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr John Howes
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Address
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DemeRx, Inc, 305 S. Andrews Avenue, Suite 515
Fort Lauderdale, FL 33301 USA
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Country
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United States of America
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Phone
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+1 954 607 3670
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Fax
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Email
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[email protected]
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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
Switching Opioid-Dependent Patients From Methadone to Morphine: Safety, Tolerability, and Methadone Pharmacokinetics.
2016
https://dx.doi.org/10.1002/jcph.704
Embase
Ascending Single-Dose, Double-Blind, Placebo-Controlled Safety Study of Noribogaine in Opioid-Dependent Patients.
2016
https://dx.doi.org/10.1002/cpdd.254
N.B. These documents automatically identified may not have been verified by the study sponsor.
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