Back to resultsTrial of Modafinil for Methamphetamine Dependence
Primary Purpose
Amphetamine Dependence
Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Modafinil
Sponsored by
About this trial
This is an interventional treatment trial for Amphetamine Dependence focused on measuring Modafinil, Amphetamine Dependence, Randomised placebo-controlled trial
Eligibility Criteria
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
Sites / Locations
- Alcohol and Drug Services, St Vincent's Hospital
- Kirketon Road Centre
Outcomes
Primary Outcome Measures
Urinalysis results negative for methamphetamine over 10 weeks
Adverse events
Compliance
Retention
Secondary Outcome Measures
Self reported drug use
Health outcomes
Psychosocial outcomes
Full Information
NCT ID
NCT00123370
First Posted
July 21, 2005
Last Updated
April 29, 2007
Sponsor
The University of New South Wales
Collaborators
Australian Government Department of Health and Ageing, Kirketon Road Centre, Sydney Hospital, St Vincent's Hospital, Sydney
1. Study Identification
Unique Protocol Identification Number
NCT00123370
Brief Title
Trial of Modafinil for Methamphetamine Dependence
Official Title
Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The University of New South Wales
Collaborators
Australian Government Department of Health and Ageing, Kirketon Road Centre, Sydney Hospital, St Vincent's Hospital, Sydney
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine Dependence
Keywords
Modafinil, Amphetamine Dependence, Randomised placebo-controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
87 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Modafinil
Primary Outcome Measure Information:
Title
Urinalysis results negative for methamphetamine over 10 weeks
Time Frame
10 weeks
Title
Adverse events
Time Frame
10 weeks
Title
Compliance
Time Frame
10 weeks
Title
Retention
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Self reported drug use
Time Frame
10 weeks
Title
Health outcomes
Time Frame
10 weeks
Title
Psychosocial outcomes
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard P Mattick, PhD
Organizational Affiliation
University of New South Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alcohol and Drug Services, St Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Kirketon Road Centre
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
20565514
Citation
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.
Results Reference
derived
PubMed Identifier
19149817
Citation
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.
Results Reference
derived
Learn more about this trial
Trial of Modafinil for Methamphetamine Dependence
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