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ClinicalTrials.gov Identifier: NCT00123370
Recruitment Status : Unknown
Verified July 2006 by The University of New South Wales. Recruitment status was: Active, not recruiting
First Posted : 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 methamphetamine 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 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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) amphetamine dependence diagnosis
Amphetamine positive urine sample at intake
Regular current amphetamine use (2-3 days per week)
Aged 18 years or older
Pregnant or nursing females
Hazardous concurrent uncontrolled physical or mental illness