Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence

This study has been completed.
Information provided by (Responsible Party):
Gantt Galloway, PharmD, California Pacific Medical Center Research Institute Identifier:
First received: May 12, 2011
Last updated: July 1, 2013
Last verified: July 2013

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 Intervention Phase
Methamphetamine 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 Randomized, Placebo-Controlled Trial 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:
  • Urine Samples Negative for Methamphetamine [ Time Frame: Twice weekly for 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: October 2011
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modafinil Drug: Modafinil
600 mg Modafinil capsule
Placebo Comparator: placebo (cornstarch)


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age between 18 and 50 years
  • 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 identifier: NCT01354470

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
Principal Investigator: Gantt Galloway, PharmD California Pacific Medical Center
  More Information

No publications provided

Responsible Party: Gantt Galloway, PharmD, Scientist, California Pacific Medical Center Research Institute Identifier: NCT01354470     History of Changes
Other Study ID Numbers: CPMC-APRL-8B
Study First Received: May 12, 2011
Last Updated: July 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by California Pacific Medical Center Research Institute:
Methamphetamine Addiction
Methamphetamine Treatment

Additional relevant MeSH terms:
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Wakefulness-Promoting Agents processed this record on March 03, 2015