Cocaine Effects in Humans: Physiology and Behavior - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

September 10, 2008

Start Date ^ICMJE

January 1997

Primary Completion Date

January 1998 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Interaction of cocaine and meds on cardio [ Time Frame: 3 hr ] [ Designated as safety issue: Yes ]
Interaction of cocaine & meds on coc's subjective [ Time Frame: 3 hr ] [ Designated as safety issue: Yes ]
Effects of medication on cocaine craving [ Time Frame: 3 hr ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Interaction of cocaine and meds on cardio
Interaction of cocaine & meds on coc's subjective
Effects of medication on cocaine craving

Change History

Complete list of historical versions of study NCT00000200 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Cocaine Effects in Humans: Physiology and Behavior - 1

Official Title ^ICMJE

Cocaine Effects in Humans: Physiology and Behavior

Brief Summary

The purpose of this study is to compare the effects of buprenorphine or methadone maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving, in opiate-dependent cocaine users.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

Cocaine-Related Disorders

Intervention ^ICMJE

Drug: Methadone

normal maintenance dose

Study Arms

Publications *

Foltin RW, Fischman MW. Effects of methadone or buprenorphine maintenance on the subjective and reinforcing effects of intravenous cocaine in humans. J Pharmacol Exp Ther. 1996 Sep;278(3):1153-64.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 1998

Primary Completion Date

January 1998 (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 Number ^ICMJE

NCT00000200

Other Study ID Numbers ^ICMJE

NIDA-03818-1, R01-03818-1

Has Data Monitoring Committee

Yes

Responsible Party

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Columbia University

Investigators ^ICMJE

Principal Investigator:

Marian Fischman, Ph.D.

Columbia University

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

September 2008

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