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Ph2 Modafinil Meth - 1
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), March 2009
First Received: August 23, 2007   Last Updated: March 16, 2009   History of Changes
Sponsor: National Institute on Drug Abuse (NIDA)
Collaborator: Department of Veterans Affairs
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00520286
  Purpose

The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.


Condition Intervention Phase
Methamphetamine Dependence
Drug: Modafinil
Drug: Placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Phase2, Double-Blind, Placebo-Controlled Trial of Modafinil for the Treatment of Methamphetamine Dependence

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Abstinence [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of craving [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: December 2007
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator Drug: Modafinil
200 mg or 400 mg /daily
2: Placebo Comparator Drug: Placebo
Placebo / daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be between the ages of 18 and 65
  • Methamphetamine dependent as defined by DSM-IV criteria
  • Must be in good general heath with a history of methamphetamine use at screening
  • Must be able to provide written informed consent
  • If female and of child bearing potential, must agree to use birth control.

Exclusion Criteria:

  • Please contact site for more information
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520286

Locations
United States, California
Torrance Site Active, not recruiting
Torrance, California, United States, 90502
Matrix Institute on Addictions Completed
Tarzana, California, United States, 91356
South Bay Treatment Center Recruiting
San Diego, California, United States, 92105
Contact: Andrea Jaks     619-395-0711        
United States, Colorado
University of Colorado Health Sciences Center Recruiting
Denver, Colorado, United States, 80220
Contact: Lori Clapp     303-399-8020 ext 3374        
United States, Hawaii
John A. Burns School of Medicine Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Gregory Ewing     808-585-5274        
United States, Iowa
Powell Chemical Dependency Center Recruiting
Des Moines, Iowa, United States, 50316
Contact: Pam Normandin     515-263-2445        
United States, Missouri
START Research and Treatment Recruiting
Kansas City, Missouri, United States, 64131
Contact: Caroline Rowe     816-444-5455        
United States, Utah
Salt Lake City VA Medical Center Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Suzanne Plumb     801-582-1565 ext 4220        
Sponsors and Collaborators
Investigators
Principal Investigator: Ahmed Elkashef, M.D. National Institute on Drug Abuse (NIDA)
  More Information

No publications provided

Responsible Party: National Institute on Drug Abuse ( Liza Gorgon )
Study ID Numbers: NIDA-CSP-1026-1
Study First Received: August 23, 2007
Last Updated: March 16, 2009
ClinicalTrials.gov Identifier: NCT00520286     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Additional relevant MeSH terms:
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Stimulants
Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Modafinil

ClinicalTrials.gov processed this record on February 08, 2010