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A Randomized, Placebo-Controlled Trial of Modafinil for 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.
ClinicalTrials.gov Identifier: NCT01354470
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The proposed study will establish the safety and efficacy of modafinil in the treatment of methamphetamine dependence, as well as assess the affects of modafinil on cognitive function in methamphetamine users and on methamphetamine withdrawal symptoms. In this outpatient trial, methamphetamine- dependent, treatment-seeking subjects will receive modafinil or placebo daily for four weeks, along with weekly Motivational Enhancement Therapy sessions. This study will be conducted at the Addiction & Pharmacology Laboratory in San Francisco, CA, and at the New Leaf Treatment Center in Lafayette, CA, and is expected to last one year.

Condition or disease Intervention/treatment Phase
Methamphetamine Dependence Drug: Modafinil Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
Study Start Date : October 2011
Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Modafinil Drug: Modafinil
600 mg Modafinil capsule
Placebo Comparator: placebo (cornstarch)


Outcome Measures

Primary Outcome Measures :
  1. Urine Samples Negative for Methamphetamine [ Time Frame: Twice weekly for 4 weeks ]

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:

  • Age between 18 and 50 years
  • 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): NCT01354470


Locations
United States, California
New Leaf Treatment Center
Lafayette, California, United States, 94549
CPMC Research Institute, St.Luke's Hospital
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, PharmD, Scientist, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01354470     History of Changes
Other Study ID Numbers: CPMC-APRL-8B
First Posted: May 17, 2011    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: July 2013

Keywords provided by Gantt Galloway, PharmD, California Pacific Medical Center Research Institute:
Meth
Methamphetamine Addiction
Methamphetamine Treatment
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