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Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

NCT ID: NCT00123383

Last Updated: 2007-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Cocaine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Modafinil

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Australian Government Department of Health and Ageing

OTHER_GOV

Sponsor Role collaborator

Kirketon Road Centre, Sydney Hospital

UNKNOWN

Sponsor Role collaborator

St Vincent's Hospital, Sydney

OTHER

Sponsor Role collaborator

The University of New South Wales

OTHER

Sponsor Role lead

Principal Investigators

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Richard P Mattick, PhD

Role: PRINCIPAL_INVESTIGATOR

University of New South Wales

Locations

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Alcohol & Drug Services, St Vincent's Hospital

Darlinghurst, New South Wales, Australia

Site Status

Kirketon Road Centre, Sydney Hospital

Darlinghurst, New South Wales, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 20565514 (View on PubMed)

Other Identifiers

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HREC05023

Identifier Type: -

Identifier Source: org_study_id