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Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by The University of New South Wales.
Recruitment status was  Active, not recruiting
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
ClinicalTrials.gov Identifier:
NCT00123383
First received: July 21, 2005
Last updated: April 29, 2007
Last verified: July 2006
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided by The University of New South Wales

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00123383     History of Changes
Other Study ID Numbers: HREC05023
Study First Received: July 21, 2005
Last Updated: April 29, 2007
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

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Modafinil
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Central Nervous System Stimulants
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013