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A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00538655
First Posted: October 3, 2007
Last Update Posted: June 3, 2013
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.
Information provided by (Responsible Party):
Gantt Galloway, PharmD, California Pacific Medical Center Research Institute
  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 such as the amphetamines, methylphenidate, and pemoline. 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 co-administered with intravenous methamphetamine. We will conduct a pilot, open-label clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.

Specific Aims:

  1. Determine the safety of modafinil in the treatment of methamphetamine dependence.
  2. Determine the efficacy of modafinil in the treatment of methamphetamine dependence.
  3. Assess the effect of modafinil on cognitive function in methamphetamine users.
  4. Assess the effect of modafinil on methamphetamine withdrawal symptoms.
  5. Compare the validity of a cellular telephone-based reporting system for assessing medication regimen adherence to conventional electronic medication monitoring.

Hypotheses:

  1. Modafinil will be as safe and well tolerated as placebo in a comparison group from another study.
  2. Subjects given modafinil will use less methamphetamine than subjects given placebo.
  3. Subjects given modafinil with demonstrate improvements in cognitive function when compared to subjects given placebo.
  4. Subjects given modafinil will have reduced withdrawal symptoms when compared to subjects given placebo.
  5. Adherence will be recorded more accurately by cellular telephone than by conventional electronic medication monitoring.

Condition Intervention Phase
Methamphetamine Addiction Drug: modafinil Phase 2

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence

Resource links provided by NLM:


Further study details as provided by Gantt Galloway, PharmD, California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • MA (-) urine samples [ Time Frame: multiple ]

Enrollment: 20
Study Start Date: January 2008
Study Completion Date: June 2011
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: modafinil Drug: modafinil
400mg vs. 200mg (PO) daily
Other Name: Provigil

  Eligibility

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:

  • Age between 18 and 50 years
  • Patient is agreeable to conditions of study and signs consent form
  • Fluency in English

Contact site for additional information.

  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): NCT00538655


Locations
United States, California
CPMC - St. Luke's Hospital ~ 7th Floor/ Addiction Pharmacology Research Lab
San Francisco, California, United States, 94110
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Investigators
Principal Investigator: Gantt Galloway, Pharm D. California Pacific Medical Center
  More Information

Responsible Party: Gantt Galloway, PharmD, Scientist, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00538655     History of Changes
Other Study ID Numbers: 27.004
First Submitted: October 2, 2007
First Posted: October 3, 2007
Last Update Posted: June 3, 2013
Last Verified: May 2013

Keywords provided by Gantt Galloway, PharmD, California Pacific Medical Center Research Institute:
amphetamine
methamphetamine
addition
treatment study
drug use
modafinil

Additional relevant MeSH terms:
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