Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 10
- Locations
- 4
- Primary Endpoint
- Urinalysis negative for cocaine over 10 weeks
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- •Pregnant or nursing females
- •Concurrent uncontrolled physical or mental illness
Outcomes
Primary Outcomes
Urinalysis negative for cocaine 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
- Self reported drug use(10 weeks)
- Health outcomes(10 weeks)
- Psychosocial outcomes(10 weeks)