Assessment of Potential Interactions Between Cocaine and RPR 102681 - 1

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ClinicalTrials.gov Identifier: NCT00067535

Recruitment Status : Completed

First Posted : August 25, 2003

Last Update Posted : January 12, 2017

Sponsor:

Information provided by:

National Institute on Drug Abuse (NIDA)

Tracking Information

First Submitted Date ^ICMJE

August 21, 2003

First Posted Date ^ICMJE

August 25, 2003

Last Update Posted Date

January 12, 2017

Study Start Date ^ICMJE

June 2003

Actual 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 ]

Original Primary Outcome Measures ^ICMJE

Safety

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

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 ^ICMJE

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic

Condition ^ICMJE

Cocaine-Related Disorders

Intervention ^ICMJE

Drug: Cocaine-Related Disorders

Study Arms ^ICMJE

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

Actual Enrollment ^ICMJE

Original Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

June 2005

Actual 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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 45 Years (Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00067535

Other Study ID Numbers ^ICMJE

NIDA-CPU-0003-1

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

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

PRS Account

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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