Effects of Modafinil in 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. Identifier: NCT00751023
Recruitment Status : Completed
First Posted : September 11, 2008
Last Update Posted : August 5, 2011
Information provided by:
Medical University of South Carolina

September 10, 2008
September 11, 2008
August 5, 2011
February 2009
July 2010   (Final data collection date for primary outcome measure)
Percentage of methamphetamine-positive urine drug screens [ Time Frame: 5 weeks ]
Same as current
Complete list of historical versions of study NCT00751023 on Archive Site
  • Score on the California Verbal Learning Test [ Time Frame: 5 weeks ]
  • Score on the Symbol Digit Modalities Test [ Time Frame: 5 weeks ]
  • Score on the Paced Auditory Serial Addition Test [ Time Frame: 5 weeks ]
  • Score on the Wisconsin Card Sort Test [ Time Frame: 5 weeks ]
  • Score on the Grooved Pegboard Test [ Time Frame: 5 weeks ]
  • Score on the Shipley Institute of Living Scale [ Time Frame: 5 weeks ]
  • Score on the Beck Depression Inventory [ Time Frame: 5 weeks ]
  • Effects on cue-induced craving for methamphetamine [ Time Frame: 5 weeks ]
Same as current
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Effects of Modafinil in Methamphetamine Dependence
Effects of Modafinil in Methamphetamine Dependence
Methamphetamine dependence is a serious public health problem with no pharmacologic treatments currently available. Relapse rates are high in this population. Exposure to cues previously associated with methamphetamine use may induce profound craving in abstinent individuals. Chronic methamphetamine abuse is associated with selective cognitive deficits that may undermine successful participation in psychosocial treatments. Medications which improve cognitive deficits in methamphetamine-dependent individuals may improve abstinence rates, especially in the critical early period of recovery. Modafinil is an atypical stimulant medication with evidence to support its use in treating cocaine dependence and attention deficit/hyperactivity disorder. The proposed studies are designed to evaluate modafinil as a potential treatment for methamphetamine dependence and its cognitive sequelae.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Methamphetamine Dependence
  • Drug: Modafinil
    400 mg daily for four weeks
    Other Name: Provigil
  • Drug: Placebo
    Placebo 2 tablets daily for 4 weeks
  • Experimental: 1
    Modafinil 400 mg daily
    Intervention: Drug: Modafinil
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2010
July 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
  2. Subjects must meet DSM-IV criteria for methamphetamine dependence within the past six months. Subjects may meet criteria for abuse, but not dependence on any other substance with the exception of nicotine. Because of the high comorbidity of methamphetamine and nicotine dependence, excluding nicotine dependence would seriously compromise the feasibility of recruitment. Nicotine use immediately prior to the cue reactivity testing session will be controlled.
  3. Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for 24 hours prior to the cue reactivity testing sessions.
  4. Subjects must consent to random assignment to the modafinil vs. placebo conditions.

Exclusion Criteria:

  1. Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
  2. Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease as these conditions may affect heart rate or skin conductance measurement.
  3. Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may impact cue reactivity.
  4. Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) for 24 hours prior the cue procedures.
  5. Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or methamphetamine as appropriate) within the past 60 days.
  6. Subjects currently taking B-blockers, anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
  7. Known or suspected hypersensitivity to modafinil.
  8. Individuals taking medications that could adversely interact with study medications.
  9. Subjects with a history of epilepsy or seizure disorder.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Bryan K. Tolliver, M.D., Ph.D., MUSC Department of Psychiatry, Division of Clinical Neuroscience
Medical University of South Carolina
Not Provided
Principal Investigator: Bryan K Tolliver, MD, PhD Medical University of South Carolina
Medical University of South Carolina
November 2009

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