Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence
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ClinicalTrials.gov Identifier: NCT00123383
Verified July 2006 by The University of New South Wales. Recruitment status was: Active, not recruiting
: July 22, 2005
Last Update Posted
: May 1, 2007
The University of New South Wales
Australian Government Department of Health and Ageing
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.
Condition or disease
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Pregnant or nursing females
Concurrent uncontrolled physical or mental illness
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers