Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

Sponsor

The University of New South Wales (Other)

Overall Status

Unknown status

CT.gov ID

NCT00123383

Collaborator

Australian Government Department of Health and Ageing (Other), Kirketon Road Centre, Sydney Hospital (Other), St Vincent's Hospital, Sydney (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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 cocaine dependence.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Dependence	Drug: Modafinil	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

Study Start Date :

Jul 1, 2005

Anticipated Study Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

Urinalysis negative for cocaine over 10 weeks [10 weeks]
Adverse events [10 weeks]
Compliance [10 weeks]
Retention [10 weeks]

Secondary Outcome Measures

Self reported drug use [10 weeks]
Health outcomes [10 weeks]
Psychosocial outcomes [10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcohol & Drug Services, St Vincent's Hospital	Darlinghurst	New South Wales	Australia	2010
2	Kirketon Road Centre, Sydney Hospital	Darlinghurst	New South Wales	Australia	2010