Ph2 Modafinil Meth - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

August 23, 2007

Last Updated Date

March 16, 2009

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Abstinence [ Time Frame: weekly ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Abstinence

Change History

Complete list of historical versions of study NCT00520286 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Reduction of craving [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Ph2 Modafinil Meth - 1

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Methamphetamine Dependence

Intervention ^ICMJE

Drug: Modafinil
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

210

Estimated Completion Date

March 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00520286

Responsible Party

Liza Gorgon, National Institute on Drug Abuse

Study ID Numbers ^ICMJE

NIDA-CSP-1026-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Department of Veterans Affairs

Investigators ^ICMJE

Principal Investigator:

Ahmed Elkashef, M.D.

National Institute on Drug Abuse (NIDA)

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP