Trial of Modafinil for Methamphetamine Dependence

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

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.

Official title: Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Urinalysis results negative for methamphetamine over 10 weeks

Adverse events

Compliance

Retention

Secondary outcome:

Self reported drug use

Health 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.

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

Kirketon Road Centre, Darlinghurst, New South Wales 2010, Australia

Alcohol and Drug Services, St Vincent's Hospital, Darlinghurst, New South Wales 2010, Australia

Starting date: July 2006
Ending date: September 2007
Last updated: April 29, 2007