Cocaine Effects in Humans: Physiology and Behavior - 1

This study has been completed.

First Received on September 20, 1999. Last Updated on September 10, 2008 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	Cocaine Effects in Humans: Physiology and Behavior

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride Methadone Methadone hydrochloride

U.S. FDA Resources

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:

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.

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

Additional relevant MeSH terms:

Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012