NCT00123370

Trial of Modafinil for Methamphetamine Dependence

Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: The University of New South Wales · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amphetamine Dependence

Interventions

Type	Name	Description
DRUG	Modafinil

Timeline

• Start date: 2006-07-01
• Completion: 2007-09-01
• First posted: 2005-07-22
• Last updated: 2007-05-01

Locations

2 sites across 1 country: Australia