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Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00123383
Recruitment Status : Unknown
Verified July 2006 by The University of New South Wales.
Recruitment status was:  Active, not recruiting
First Posted : July 22, 2005
Last Update Posted : May 1, 2007
Sponsor:
Collaborators:
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

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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: Modafinil Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence
Study Start Date : July 2005
Estimated Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Modafinil




Primary Outcome Measures :
  1. Urinalysis negative for cocaine over 10 weeks [ Time Frame: 10 weeks ]
  2. Adverse events [ Time Frame: 10 weeks ]
  3. Compliance [ Time Frame: 10 weeks ]
  4. Retention [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Self reported drug use [ Time Frame: 10 weeks ]
  2. Health outcomes [ Time Frame: 10 weeks ]
  3. Psychosocial outcomes [ Time Frame: 10 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123383


Locations
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Australia, New South Wales
Alcohol & Drug Services, St Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Kirketon Road Centre, Sydney 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
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Principal Investigator: Richard P Mattick, PhD University of New South Wales
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00123383    
Other Study ID Numbers: HREC05023
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: May 1, 2007
Last Verified: July 2006
Keywords provided by The University of New South Wales:
Modafinil
Cocaine Dependence
Randomised placebo-controlled trial
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action