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
  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 methamphetamine dependence.


Condition Intervention Phase
Amphetamine 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 Methamphetamine Dependence

Resource links provided by NLM:


Further study details as provided by The University of New South Wales:

Primary Outcome Measures:
  • 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 ]

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: 87
Study Start Date: July 2006
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123370

Locations
Australia, New South Wales
Kirketon Road Centre
Darlinghurst, New South Wales, Australia, 2010
Alcohol and 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: NCT00123370     History of Changes
Other Study ID Numbers: HREC05025
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
Amphetamine Dependence
Randomised placebo-controlled trial

Additional relevant MeSH terms:
Amphetamine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methamphetamine
Modafinil
Armodafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on August 28, 2014