Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

Phase 2

• Conditions: Cocaine Dependence

• Registration Number: NCT00123383
• 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 cocaine 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 liability. Thirty dependent cocaine users will be randomised 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 cocaine negative urine samples collected over the 10 week study period. Adverse events, side effects, compliance, retention, self reported health, psychosocial and drug use outcomes will also be compared between the groups.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-07-21
• Study First Submitted QC: 2005-07-21
• Study First Posted: 2005-07-22
• Status Verified: 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: 10

Inclusion Criteria

• DSM-IV cocaine dependence diagnosis
• Cocaine positive urine sample at intake
• Regular current cocaine use (2-3 days per week)
• Aged 18 years or older

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Exclusion Criteria

• Pregnant or nursing females
• Concurrent uncontrolled physical or mental illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

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

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