Clinical Trial: Trial of Modafinil for Methamphetamine Dependence

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: The University of New South Wales

Current Primary Outcome:

  • 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:

  • Urinalysis results negative for methamphetmaine over 10 weeks
  • Adverse events
  • Compliance
  • Retention


Current Secondary Outcome:

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


Original Secondary Outcome:

  • Self reported drug use
  • Health outcomes
  • Psychosocial outcomes


Information By: The University of New South Wales

Dates:
Date Received: July 21, 2005
Date Started: July 2006
Date Completion: September 2007
Last Updated: April 29, 2007
Last Verified: July 2006