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Cocaine Effects in Humans: Physiology and Behavior - 1

Primary Purpose

Cocaine-Related Disorders

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Methadone

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring self-administration

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

Interaction of cocaine and meds on cardio

Interaction of cocaine & meds on coc's subjective

Effects of medication on cocaine craving

Secondary Outcome Measures

Full Information

NCT ID

NCT00000200

First Posted

September 20, 1999

Last Updated

January 11, 2017

Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT00000200

Brief Title

Cocaine Effects in Humans: Physiology and Behavior - 1

Official Title

Cocaine Effects in Humans: Physiology and Behavior

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

January 1997 (undefined)

Primary Completion Date

January 1998 (Actual)

Study Completion Date

January 1998 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

Columbia University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine-Related Disorders

Keywords

self-administration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare Provider

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Methadone

Intervention Description

normal maintenance dose

Primary Outcome Measure Information:

Title

Interaction of cocaine and meds on cardio

Time Frame

3 hr

Title

Interaction of cocaine & meds on coc's subjective

Time Frame

3 hr

Title

Effects of medication on cocaine craving

Time Frame

3 hr

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Please contact site for information.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marian Fischman, 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

Citations:

PubMed Identifier

8819498

Citation

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.

Results Reference

result

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Cocaine Effects in Humans: Physiology and Behavior - 1

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