A Phase 2 interventional study of Modafinil in Cocaine Dependence, sponsored by The University of New South Wales. Status unknown at 2 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-05-01.
Sponsored by The University of New South Wales · Phase 2, Interventional, and Treatment
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.
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.
415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.
This study's planned enrollment of 10 is below the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.
Browse Cocaine-Related Disorders studies →The University of New South Wales is the lead sponsor of 65 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Self reported drug use
Time frame: 10 weeks
Health outcomes
Time frame: 10 weeks
Psychosocial outcomes
Time frame: 10 weeks
This study is status unknown, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.
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The University of New South Wales