Overview

This trial is active, not recruiting.

Condition amphetamine dependence
Treatment modafinil
Phase phase 2
Sponsor The University of New South Wales
Collaborator Australian Government Department of Health and Ageing
Start date July 2006
End date September 2007
Trial size 87 participants
Trial identifier NCT00123370, HREC05025

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
Urinalysis results negative for methamphetamine over 10 weeks
time frame: 10 weeks
Adverse events
time frame: 10 weeks
Compliance
time frame: 10 weeks
Retention
time frame: 10 weeks

Secondary Outcomes

Measure
Self reported drug use
time frame: 10 weeks
Health outcomes
time frame: 10 weeks
Psychosocial outcomes
time frame: 10 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
Principal investigator Richard P Mattick, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by The University of New South Wales.