Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence - Full Text View

Sponsors and Collaborators:	The University of New South Wales Australian Government Department of Health and Ageing Kirketon Road Centre, Sydney Hospital St Vincent's Hospital, Sydney
Information provided by:	The University of New South Wales
ClinicalTrials.gov Identifier:	NCT00123383

Purpose

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	Intervention	Phase
Cocaine Dependence	Drug: Modafinil	Phase II

Drug Information available for: Modafinil 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

Further study details as provided by The University of New South Wales:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	10
Study Start Date:	July 2005
Estimated Study Completion Date:	September 2007

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123383

Locations

Australia, New South Wales
Kirketon Road Centre, Sydney Hospital
Darlinghurst, New South Wales, Australia, 2010
Alcohol & Drug Services, St Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010

Sponsors and Collaborators

The University of New South Wales

Australian Government Department of Health and Ageing

Kirketon Road Centre, Sydney Hospital

St Vincent's Hospital, Sydney

Investigators

Principal Investigator:

Richard P Mattick, PhD

University of New South Wales

More Information

Study ID Numbers:	HREC05023
Study First Received:	July 21, 2005
Last Updated:	April 29, 2007
ClinicalTrials.gov Identifier:	NCT00123383
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The University of New South Wales:

Modafinil
Cocaine Dependence
Randomised placebo-controlled trial

Study placed in the following topic categories:

Cocaine-Related Disorders
Dopamine
Mental Disorders
Substance-Related Disorders

Disorders of Environmental Origin
Cocaine
Modafinil

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Central Nervous System Stimulants
Cardiovascular Agents
Protective Agents

Neuroprotective Agents
Pharmacologic Actions
Anesthetics, Local
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009