Clinical trial NCT00123383: Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence
Official title: Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cocaine Dependence
Keywords: Modafinil
Cocaine Dependence
Randomised placebo-controlled trial
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: Australian Government Department of Health and Ageing
name: Kirketon Road Centre, Sydney Hospital
name: St Vincent's Hospital, Sydney
First posted: 2005-07-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Urinalysis negative for cocaine over 10 weeks
timeFrame: 10 weeks
measure: Adverse events
timeFrame: 10 weeks
measure: Compliance
timeFrame: 10 weeks
measure: Retention
timeFrame: 10 weeks
Secondary outcomes:
measure: Self reported drug use
timeFrame: 10 weeks
measure: Health outcomes
timeFrame: 10 weeks
measure: Psychosocial outcomes
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: Alcohol & Drug Services, St Vincent's Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: Kirketon Road Centre, Sydney Hospital
state: New South Wales
Study officials:
affiliation: University of New South Wales
name: Richard P Mattick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shearer J, Shanahan M, Darke S, Rodgers C, van Beek I, McKetin R, Mattick RP. A cost-effectiveness analysis of modafinil therapy for psychostimulant dependence. Drug Alcohol Rev. 2010 May;29(3):235-42. doi: 10.1111/j.1465-3362.2009.00148.x.