Assessment of Potential Interactions Between Cocaine and RPR 102681 - 1

This study has been completed.

First Received on August 21, 2003. Last Updated on February 2, 2009 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00067535

Purpose

The purpose of this study is to assess Potential Interactions Between iv Cocaine and RPR 102681

Condition	Intervention	Phase
Cocaine-Related Disorders	Drug: Cocaine-Related Disorders	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Diagnostic
Official Title:	Potential Interactions Between IV Cocaine and RPR 102681

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Cocaine hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

Hemodynamic response to cocaine and subjective response to cocaine [ Time Frame: 3x / 30 days ] [ Designated as safety issue: Yes ]

Enrollment:	16
Study Start Date:	June 2003
Study Completion Date:	June 2005
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Detailed Description:

Phase I, Double-Blind, Placebo-Controlled Dose Escalating Assessment of Potential Interactions Between Intravenous Cocaine and RPR 102681

Eligibility

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

Criteria

Inclusion Criteria:

Includes but is not limited to:

Non-treatment seekers
DSM-IV criteria for cocaine abuse or dependence
Ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements

Exclusion Criteria:

Please contact site for more information.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067535

Locations

United States, Maryland
Uniformed Services University of Health Science
Bethesda, Maryland, United States, 20814 4799

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Louis Cantilena, M.D.

Uniformed Services University of Health Science

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00067535 History of Changes
Other Study ID Numbers:	NIDA-CPU-0003-1
Study First Received:	August 21, 2003
Last Updated:	February 2, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012