Trial of Modafinil for Methamphetamine Dependence
Information source: The University of New South Wales
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Amphetamine Dependence
Intervention: Modafinil (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: The University of New South Wales Official(s) and/or principal investigator(s): Richard P Mattick, PhD, Principal Investigator, Affiliation: University of New South Wales
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 methamphetamine
dependence.
Clinical Details
Official title: Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Urinalysis results negative for methamphetamine over 10 weeksAdverse events Compliance Retention
Secondary outcome: Self reported drug useHealth outcomes Psychosocial outcomes
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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant or nursing females
- Hazardous concurrent uncontrolled physical or mental illness
Locations and Contacts
Alcohol and Drug Services, St Vincent's Hospital, Darlinghurst, New South Wales 2010, Australia
Kirketon Road Centre, Darlinghurst, New South Wales 2010, Australia
Additional Information
Starting date: July 2006
Last updated: April 29, 2007
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