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Trial of Modafinil for Methamphetamine 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:
NCT00123370
First received: July 21, 2005
Last updated: April 29, 2007
Last verified: July 2006
History of Changes

July 21, 2005
April 29, 2007
July 2006
Not Provided
  • 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 ]
  • Urinalysis results negative for methamphetmaine over 10 weeks
  • Adverse events
  • Compliance
  • Retention
Complete list of historical versions of study NCT00123370 on ClinicalTrials.gov Archive Site
  • Self reported drug use [ Time Frame: 10 weeks ]
  • Health outcomes [ Time Frame: 10 weeks ]
  • Psychosocial outcomes [ Time Frame: 10 weeks ]
  • Self reported drug use
  • Health outcomes
  • Psychosocial outcomes
Not Provided
Not Provided
 
Trial of Modafinil for Methamphetamine Dependence
Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Amphetamine Dependence
Drug: Modafinil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
87
September 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00123370
HREC05025
No
Not Provided
The University of New South Wales
  • Australian Government Department of Health and Ageing
  • Kirketon Road Centre, Sydney Hospital
  • St Vincent's Hospital, Sydney
Principal Investigator: Richard P Mattick, PhD University of New South Wales
The University of New South Wales
July 2006

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