- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00123370
Trial of Modafinil for Methamphetamine Dependence
April 29, 2007 updated by: The University of New South Wales
Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
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 methamphetamine 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 potential.
Sixty dependent methamphetamine users will be allocated 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 methamphetamine negative urine samples over the 10 week study period.
Adverse events, side effects, compliance, retention and self reported health, psychosocial and drug use will also be compared between the study groups.
Study Type
Interventional
Enrollment (Anticipated)
87
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
-
-
New South Wales
-
Darlinghurst, New South Wales, Australia, 2010
- Kirketon Road Centre
-
Darlinghurst, New South Wales, Australia, 2010
- Alcohol and Drug Services, St Vincent's Hospital
-
-
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:
- Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) amphetamine dependence diagnosis
- Amphetamine positive urine sample at intake
- Regular current amphetamine use (2-3 days per week)
- Aged 18 years or older
Exclusion Criteria:
- Pregnant or nursing females
- Hazardous 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
|
Urinalysis results negative for methamphetamine over 10 weeks
Time Frame: 10 weeks
|
10 weeks
|
Compliance
Time Frame: 10 weeks
|
10 weeks
|
Retention
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.
General Publications
- Shearer J, Shanahan M, Darke S, Rodgers C, van Beek I, McKetin R, Mattick RP. A cost-effectiveness analysis of modafinil therapy for psychostimulant dependence. Drug Alcohol Rev. 2010 May;29(3):235-42. doi: 10.1111/j.1465-3362.2009.00148.x.
- Shearer J, Darke S, Rodgers C, Slade T, van Beek I, Lewis J, Brady D, McKetin R, Mattick RP, Wodak A. A double-blind, placebo-controlled trial of modafinil (200 mg/day) for methamphetamine dependence. Addiction. 2009 Feb;104(2):224-33. doi: 10.1111/j.1360-0443.2008.02437.x.
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, 2006
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
- Amphetamine-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
- HREC05025
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.
Clinical Trials on Amphetamine Dependence
-
National Taiwan University HospitalUnknownMethamphetamine Dependence | Methamphetamine Abuse | Amphetamine Dependence | Amphetamine AbuseTaiwan
-
California Pacific Medical Center Research InstituteUnknownSubstance Dependence | Amphetamine DependenceUnited States
-
University of California, Los AngelesNational Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Methamphetamine | Pharmacogenetics | Methamphetamine Dependence | Amphetamine DependenceUnited States
-
Universiti Sains MalaysiaYale UniversityUnknownHeroin Dependence | Amphetamine DependenceMalaysia
-
Universiti Sains MalaysiaYale UniversityUnknownHeroin Dependence | Amphetamine DependenceMalaysia
-
Universiti Sains MalaysiaYale UniversityUnknownHeroin Dependence | Amphetamine DependenceMalaysia
-
University of VirginiaAmerican Association of Chairs of Departments of PsychiatryWithdrawnAmphetamine DependenceUnited States
-
University of PennsylvaniaNational Institute on Drug Abuse (NIDA); Society of Alcoholism and other AddictionsCompletedAmphetamine DependenceIceland
-
University of Southern CaliforniaNational Institute on Drug Abuse (NIDA); University of Toronto; RTI InternationalCompletedSubstance Abuse, Intravenous | HIV | Heroin Dependence | Opioid Dependence | Cocaine Dependence | Amphetamine DependenceUnited States
-
University of Texas Southwestern Medical CenterStanley Medical Research InstituteCompletedBipolar Disorder | Major Depressive Disorder | Amphetamine Dependence | Amphetamine AbuseUnited States
Clinical Trials on Modafinil
-
The Cooper Health SystemCompletedPostoperative Cognitive Dysfunction
-
Genuine Research Center, EgyptChemipharm Pharmaceutical Industries, EgyptCompleted
-
University of PennsylvaniaNational Institute on Drug Abuse (NIDA)Completed
-
SanofiCompletedBreast Cancer | Prostatic NeoplasmsAustralia
-
Jonsson Comprehensive Cancer CenterCephalonCompletedFatigue | Brain and Central Nervous System Tumors | Cognitive/Functional EffectsUnited States
-
VA Palo Alto Health Care SystemTerminatedInsomnia | Sleep Initiation and Maintenance Disorders | Alzheimer DiseaseUnited States
-
California Pacific Medical Center Research InstituteCompletedMethamphetamine AddictionUnited States
-
California Pacific Medical Center Research InstituteUnknownSubstance Dependence | Amphetamine DependenceUnited States
-
Cephalon, Inc.TerminatedObstructive Sleep Apnea | Narcolepsy | Shift Work Sleep DisorderUnited States