Assessment of Potential Interactions Between Cocaine and RPR 102681 - 1

This study has been completed.

Sponsor:

Information provided by:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT00067535

First received: August 21, 2003

Last updated: February 2, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

August 21, 2003

Last Updated Date

February 2, 2009

Start Date ^ICMJE

June 2003

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00067535 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Assessment of Potential Interactions Between Cocaine and RPR 102681 - 1

Official Title ^ICMJE

Potential Interactions Between IV Cocaine and RPR 102681

Brief Summary

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

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic

Condition ^ICMJE

Cocaine-Related Disorders

Intervention ^ICMJE

Drug: Cocaine-Related Disorders

Study Arm (s)

Not Provided

Publications *

Not Provided

* 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

June 2005

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

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

NCT00067535

Other Study ID Numbers ^ICMJE

NIDA-CPU-0003-1

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Louis Cantilena, M.D.

Uniformed Services University of Health Science

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

February 2009

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

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