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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Methamphetamine Dependence Drug: Modafinil Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Modafinil in Methamphetamine Dependence
Study Start Date : February 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arm Intervention/treatment
Experimental: 1
Modafinil 400 mg daily
Drug: Modafinil
400 mg daily for four weeks
Other Name: Provigil

Placebo Comparator: 2
Drug: Placebo
Placebo 2 tablets daily for 4 weeks

Primary Outcome Measures :
  1. Percentage of methamphetamine-positive urine drug screens [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. Score on the California Verbal Learning Test [ Time Frame: 5 weeks ]
  2. Score on the Symbol Digit Modalities Test [ Time Frame: 5 weeks ]
  3. Score on the Paced Auditory Serial Addition Test [ Time Frame: 5 weeks ]
  4. Score on the Wisconsin Card Sort Test [ Time Frame: 5 weeks ]
  5. Score on the Grooved Pegboard Test [ Time Frame: 5 weeks ]
  6. Score on the Shipley Institute of Living Scale [ Time Frame: 5 weeks ]
  7. Score on the Beck Depression Inventory [ Time Frame: 5 weeks ]
  8. Effects on cue-induced craving for methamphetamine [ Time Frame: 5 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00751023

United States, South Carolina
Behavioral Health Services of Pickens County
Pickens, South Carolina, United States, 29671
Sponsors and Collaborators
Medical University of South Carolina
Principal Investigator: Bryan K Tolliver, MD, PhD Medical University of South Carolina

Responsible Party: Bryan K. Tolliver, M.D., Ph.D., MUSC Department of Psychiatry, Division of Clinical Neuroscience Identifier: NCT00751023     History of Changes
Other Study ID Numbers: HR#18440
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: August 5, 2011
Last Verified: November 2009

Keywords provided by Medical University of South Carolina:

Additional relevant MeSH terms:
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