Dextroamphetamine as an Adjunct in Cocaine Treatment - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

August 14, 2008

Start Date ^ICMJE

August 1997

Primary Completion Date

August 2001 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

verifiable cocaine abstinence [ Time Frame: 16 weeks of study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Craving
Drug use
Medication compliance
Retention
Addiction severity
Mood indicators
Psychiatric interview

Change History

Complete list of historical versions of study NCT00000304 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Dextroamphetamine as an Adjunct in Cocaine Treatment - 1

Official Title ^ICMJE

Dextroamphetamine as an Adjunct in Cocaine Treatment

Brief Summary

The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in cocaine treatment; an evaluation of the ""replacement"" strategy.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Cocaine-Related Disorders
Substance-Related Disorders

Intervention ^ICMJE

Drug: Dextroamphetamine
Drug: D-Amphetamine
Drug: Placebo

Study Arms / Comparison Groups

Experimental: 15/30 mg d-amphetamine
Experimental: 30/60 mg d-amphetamine
Experimental: placebo

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

Completed

Enrollment ^ICMJE

120

Completion Date

August 2001

Primary Completion Date

August 2001 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Please contact site for information.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000304

Responsible Party

F.Gerard Moeller, University of Texas Medical School at Houston

Study ID Numbers ^ICMJE

NIDA-09262-1, P50-09262-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

University of Texas

Investigators ^ICMJE

Principal Investigator:

John Grabowski, Ph.D.

University of Texas

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

August 2008

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