Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence - Tabular View

Tracking Information

First Received Date ^ICMJE

July 21, 2005

Last Updated Date

April 29, 2007

Start Date ^ICMJE

July 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Urinalysis negative for cocaine over 10 weeks
Adverse events
Compliance
Retention

Change History

Complete list of historical versions of study NCT00123383 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Self reported drug use [ Time Frame: 10 weeks ]
Health outcomes [ Time Frame: 10 weeks ]
Psychosocial outcomes [ Time Frame: 10 weeks ]

Original Secondary Outcome Measures ^ICMJE

Self reported drug use
Health outcomes
Psychosocial outcomes

Descriptive Information

Brief Title ^ICMJE

Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

Official Title ^ICMJE

Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

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.

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Cocaine Dependence

Intervention ^ICMJE

Drug: Modafinil

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT ID ^ICMJE

NCT00123383

Responsible Party

Study ID Numbers ^ICMJE

HREC05023

Study Sponsor ^ICMJE

The University of New South Wales

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Richard P Mattick, PhD

University of New South Wales

Information Provided By

The University of New South Wales

Verification Date

July 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP