Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

Condition(s) targeted: Cocaine 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 cocaine dependence.

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

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

Primary outcome:

Urinalysis negative for cocaine 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 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- Pregnant or nursing females

- Concurrent uncontrolled physical or mental illness

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

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

Starting date: July 2005
Ending date: September 2007
Last updated: April 29, 2007