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Trial of Modafinil for Methamphetamine 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: NCT00123370
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

Tracking Information
First Submitted Date  ICMJE July 21, 2005
First Posted Date  ICMJE July 22, 2005
Last Update Posted Date May 1, 2007
Study Start Date  ICMJE July 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2007)
  • Urinalysis results negative for methamphetamine over 10 weeks [ Time Frame: 10 weeks ]
  • Adverse events [ Time Frame: 10 weeks ]
  • Compliance [ Time Frame: 10 weeks ]
  • Retention [ Time Frame: 10 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2005)
  • Urinalysis results negative for methamphetmaine over 10 weeks
  • Adverse events
  • Compliance
  • Retention
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2007)
  • Self reported drug use [ Time Frame: 10 weeks ]
  • Health outcomes [ Time Frame: 10 weeks ]
  • Psychosocial outcomes [ Time Frame: 10 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2005)
  • Self reported drug use
  • Health outcomes
  • Psychosocial outcomes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Modafinil for Methamphetamine Dependence
Official Title  ICMJE Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
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 methamphetamine 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 potential. Sixty dependent methamphetamine users will be allocated 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 methamphetamine negative urine samples over the 10 week study period. Adverse events, side effects, compliance, retention and self reported health, psychosocial and drug use will also be compared between the study groups.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Amphetamine Dependence
Intervention  ICMJE Drug: Modafinil
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 29, 2007)		 87
Original Enrollment  ICMJE
 (submitted: July 21, 2005)		 60
Estimated Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) amphetamine dependence diagnosis
  • Amphetamine positive urine sample at intake
  • Regular current amphetamine use (2-3 days per week)
  • Aged 18 years or older

Exclusion Criteria:

  • Pregnant or nursing females
  • Hazardous concurrent uncontrolled physical or mental illness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00123370
Other Study ID Numbers  ICMJE HREC05025
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE The University of New South Wales
Collaborators  ICMJE
  • Australian Government Department of Health and Ageing
  • Kirketon Road Centre, Sydney Hospital
  • St Vincent's Hospital, Sydney
Investigators  ICMJE
Principal Investigator: Richard P Mattick, PhD University of New South Wales
PRS Account The University of New South Wales
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP