We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Amphetamine Dependence Drug: Modafinil Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
Study Start Date : July 2006
Estimated Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Urinalysis results negative for methamphetamine over 10 weeks [ Time Frame: 10 weeks ]
  2. Adverse events [ Time Frame: 10 weeks ]
  3. Compliance [ Time Frame: 10 weeks ]
  4. Retention [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Self reported drug use [ Time Frame: 10 weeks ]
  2. Health outcomes [ Time Frame: 10 weeks ]
  3. Psychosocial outcomes [ Time Frame: 10 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123370

Australia, New South Wales
Alcohol and Drug Services, St Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Kirketon Road Centre
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
Principal Investigator: Richard P Mattick, PhD University of New South Wales
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00123370     History of Changes
Other Study ID Numbers: HREC05025
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: May 1, 2007
Last Verified: July 2006

Keywords provided by The University of New South Wales:
Amphetamine Dependence
Randomised placebo-controlled trial

Additional relevant MeSH terms:
Amphetamine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors