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:

MedlinePlus related topics: Methamphetamine

Drug Information available for: Modafinil Methamphetamine

U.S. FDA Resources

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

National Institute on Drug Abuse (NIDA)

Department of Veterans Affairs

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