- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00123383
Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence
April 29, 2007 updated by: The University of New South Wales
The study aims to evaluate the safety and efficacy of modafinil (200 mg/day) over 10 weeks plus a tailored cognitive behavioural therapy program in the treatment of cocaine dependence.
Study Overview
Detailed Description
Modafinil is a novel wake promoting agent approved in Australia for the treatment of narcolepsy.
Preliminary studies have suggested that modafinil may have value in the treatment of psychostimulant dependence through positive effects on mood, sleep patterns, concentration, fatigue and drug craving.
It appears to be well tolerated with a low abuse liability.
Thirty dependent cocaine users will be randomised to 2 equal groups.
The experimental group will receive modafinil 200 mg/day for 10 weeks and a tailored cognitive behavioural therapy program.
The control group will receive placebo under equivalent conditions.
Primary outcome will be a between group comparison of cocaine negative urine samples collected over the 10 week study period.
Adverse events, side effects, compliance, retention, self reported health, psychosocial and drug use outcomes will also be compared between the groups.
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Darlinghurst, New South Wales, Australia, 2010
- Alcohol & Drug Services, St Vincent's Hospital
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Darlinghurst, New South Wales, Australia, 2010
- Kirketon Road Centre, Sydney Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- DSM-IV cocaine dependence diagnosis
- Cocaine positive urine sample at intake
- Regular current cocaine use (2-3 days per week)
- Aged 18 years or older
Exclusion Criteria:
- Pregnant or nursing females
- Concurrent uncontrolled physical or mental illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: 10 weeks
|
10 weeks
|
Compliance
Time Frame: 10 weeks
|
10 weeks
|
Retention
Time Frame: 10 weeks
|
10 weeks
|
Urinalysis negative for cocaine over 10 weeks
Time Frame: 10 weeks
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self reported drug use
Time Frame: 10 weeks
|
10 weeks
|
Health outcomes
Time Frame: 10 weeks
|
10 weeks
|
Psychosocial outcomes
Time Frame: 10 weeks
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Richard P Mattick, PhD, University of New South Wales
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Study Completion (ANTICIPATED)
September 1, 2007
Study Registration Dates
First Submitted
July 21, 2005
First Submitted That Met QC Criteria
July 21, 2005
First Posted (ESTIMATE)
July 22, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
May 1, 2007
Last Update Submitted That Met QC Criteria
April 29, 2007
Last Verified
July 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Central Nervous System Stimulants
- Wakefulness-Promoting Agents
- Modafinil
Other Study ID Numbers
- HREC05023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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