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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
87
Alcohol and Drug Services, St Vincent's Hospital
Darlinghurst, New South Wales, Australia
Kirketon Road Centre
Darlinghurst, New South Wales, Australia
Urinalysis results negative for methamphetamine 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
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