Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

Cocaine Dependence Clinical Trial

Official title:

Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00123383
• Other study ID #: HREC05023
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 21, 2005
• Last updated: April 29, 2007
• Start date: July 2005
• Est. completion date: September 2007

Study information

• Verified date: July 2006
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Modafinil

Locations

Country	Name	City	State
Australia	Alcohol & Drug Services, St Vincent's Hospital	Darlinghurst	New South Wales
Australia	Kirketon Road Centre, Sydney Hospital	Darlinghurst	New South Wales

Sponsors (4)

Lead Sponsor	Collaborator
The University of New South Wales	Australian Government Department of Health and Ageing, Kirketon Road Centre, Sydney Hospital, St Vincent's Hospital, Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinalysis negative for cocaine over 10 weeks		10 weeks
Primary	Adverse events		10 weeks
Primary	Compliance		10 weeks
Primary	Retention		10 weeks
Secondary	Self reported drug use		10 weeks
Secondary	Health outcomes		10 weeks
Secondary	Psychosocial outcomes		10 weeks