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IV Cocaine Abuse: A Laboratory Model - 2

Primary Purpose

Cocaine-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring intravenous abuse

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Please contact site for information.

Sites / Locations

  • Columbia University

Outcomes

Primary Outcome Measures

Direct cocaine effects
Interaction of cocaine/fluox. on cardio measures
Interaction of cocaine/fluox. on coc's subjective
Effects of fluoxetine on cocaine craving
Drug use during outpatient fluoxetine maintenance

Secondary Outcome Measures

Full Information

First Posted
September 20, 1999
Last Updated
August 27, 2015
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA), Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT00000213
Brief Title
IV Cocaine Abuse: A Laboratory Model - 2
Official Title
IV Cocaine Abuse: A Laboratory Model
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 1990 (undefined)
Primary Completion Date
April 1991 (Actual)
Study Completion Date
April 1991 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA), Columbia University

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
intravenous abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
0 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Primary Outcome Measure Information:
Title
Direct cocaine effects
Title
Interaction of cocaine/fluox. on cardio measures
Title
Interaction of cocaine/fluox. on coc's subjective
Title
Effects of fluoxetine on cocaine craving
Title
Drug use during outpatient fluoxetine maintenance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Please contact site for information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Foltin, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States

12. IPD Sharing Statement

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IV Cocaine Abuse: A Laboratory Model - 2

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