Trial of Modafinil for Methamphetamine Dependence

Phase 2

• Conditions: Amphetamine Dependence

• Registration Number: NCT00123370
• Lead Sponsor: The University of New South Wales

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.

Study Timeline

• Study First Submitted: 2005-07-21
• Study First Submitted QC: 2005-07-21
• Study First Posted: 2005-07-22
• Status Verified: 2006-07
• Study Start: 2006-07
• Last Update Submitted: 2007-04-29
• Last Update Posted: 2007-05-01
• Study Completion: 2007-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Urinalysis results negative for methamphetamine over 10 weeks	10 weeks
Adverse events	10 weeks
Compliance	10 weeks
Retention	10 weeks

Secondary Outcome Measures

Name	Time	Method
Health outcomes	10 weeks
Psychosocial outcomes	10 weeks
Self reported drug use	10 weeks

Trial Locations

Locations (2)

Alcohol and Drug Services, St Vincent's Hospital; 🇦🇺 Darlinghurst, New South Wales, Australia

Kirketon Road Centre; 🇦🇺 Darlinghurst, New South Wales, Australia