Cocaine Effects in Humans: Physiology and Behavior - 1 - Full Text View

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) Columbia University
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000200

Purpose

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.

Condition	Intervention	Phase
Cocaine-Related Disorders	Drug: Methadone	Phase II

Drug Information available for: Methadone Methadone hydrochloride 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Cocaine Effects in Humans: Physiology and Behavior

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

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 ]

Enrollment:	19
Study Start Date:	January 1997
Study Completion Date:	January 1998
Primary Completion Date:	January 1998 (Final data collection date for primary outcome measure)

Intervention Details:

normal maintenance dose

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Please contact site for information.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000200

Locations

United States, New York
Columbia University
New York, New York, United States, 10023

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Columbia University

Investigators

Principal Investigator:

Marian Fischman, Ph.D.

Columbia University

More Information

Publications of Results:

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.

Study ID Numbers:	NIDA-03818-1, R01-03818-1
Study First Received:	September 20, 1999
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00000200
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Study placed in the following topic categories:

Cocaine-Related Disorders
Methadone
Mental Disorders

Substance-Related Disorders
Disorders of Environmental Origin
Cocaine

ClinicalTrials.gov processed this record on January 13, 2009