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Ph2 Modafinil Meth - 1

Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Methamphetamine Dependence

Intervention: Modafinil (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Ahmed Elkashef, M.D., Principal Investigator, Affiliation: National Institute on Drug Abuse (NIDA)

Summary

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.

Clinical Details

Official title: Phase2, Double-Blind, Placebo-Controlled Trial of Modafinil for the Treatment of Methamphetamine Dependence

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Abstinence

Secondary outcome: Reduction of craving

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Torrance Site, Torrance, California 90502, United States; Recruiting
Donnie Watson, Ph.D., Phone: 310-224-4670

Matrix Institute on Addictions, Tarzana, California 91356, United States; Recruiting
Tony Pham, M.D., Phone: 310-207-4322

South Bay Treatment Center, San Diego, California 92105, United States; Recruiting
Andrea Jaks, Phone: 619-395-0711

University of Colorado Health Sciences Center, Denver, Colorado 80220, United States; Recruiting
Lori Clapp, Phone: 303-399-8020, Ext: 3374

John A. Burns School of Medicine, Honolulu, Hawaii 96813, United States; Recruiting
Gregory Ewing, Phone: 808-585-5274

Powell Chemical Dependency Center, Des Moines, Iowa 50316, United States; Recruiting
Pam Normandin, Phone: 515-263-2445

START Research and Treatment, Kansas City, Missouri 64131, United States; Recruiting
Caroline Rowe, Phone: 816-444-5455

Salt Lake City VA Medical Center, Salt Lake City, Utah 84148, United States; Recruiting
Suzanne Plumb, Phone: 801-582-1565, Ext: 4220

Additional Information

Starting date: December 2007
Ending date: March 2010
Last updated: August 11, 2008

Page last updated: November 03, 2008

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