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A Dose Ranging Study of Modafinil for Methamphetamine Dependence

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ClinicalTrials.gov Identifier: NCT00630097
Recruitment Status : Unknown
Verified June 2010 by California Pacific Medical Center Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : March 6, 2008
Last Update Posted : June 22, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
Patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d, l-2-[(diphenylmethyl)sulfinyl]acetamide) is a novel wake- and vigilance-promoting agent that is chemically and pharmacologically dissimilar to CNS stimulants. It is well tolerated and has low abuse liability compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to reduce cocaine use in dependent users, and is safe when coadministered with intravenous methamphetamine. We will conduct a randomized dose ranging clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose Ranging Study of Modafinil for Methamphetamine Dependence
Study Start Date : December 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: modafinil
    Modafinil, 100mg, 400mg, or 600 mg tablets QD for 4 weeks.

Outcome Measures

Primary Outcome Measures :
  1. Methamphetamine-negative urine samples will be analyzed using a generalized estimating equation model [ Time Frame: end of study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18 and 50 years
  2. Patient is agreeable to conditions of study and signs consent form
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): NCT00630097


Locations
United States, California
CPMC
San Francisco, California, United States, 94110
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Investigators
Principal Investigator: Gantt Galloway, PharmD California Pacific Medical Center
More Information

Responsible Party: Gantt Galloway, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00630097     History of Changes
Other Study ID Numbers: 27.140
First Posted: March 6, 2008    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2010

Keywords provided by California Pacific Medical Center Research Institute:
methamphetamine addiction, meth dependence

Additional relevant MeSH terms:
Substance-Related Disorders
Amphetamine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Modafinil
Armodafinil
Methamphetamine
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
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors