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A Dose Ranging Study of Modafinil for Methamphetamine Dependence

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by California Pacific Medical Center Research Institute.
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by:
California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00630097
First received: February 27, 2008
Last updated: June 21, 2011
Last verified: June 2010
  Purpose
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 Intervention Phase
Substance Dependence
Amphetamine Dependence
Drug: modafinil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose Ranging Study of Modafinil for Methamphetamine Dependence

Resource links provided by NLM:


Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • Methamphetamine-negative urine samples will be analyzed using a generalized estimating equation model [ Time Frame: end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: December 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: modafinil
    Modafinil, 100mg, 400mg, or 600 mg tablets QD for 4 weeks.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
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
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: 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 
Study First Received: February 27, 2008
Last Updated: June 21, 2011
Health Authority: United States: Food and Drug Administration

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

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
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers

ClinicalTrials.gov processed this record on December 09, 2016