NCT00000213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 1990

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1990

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 1991

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 1991

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
Last Updated

August 28, 2015

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

September 20, 1999

Last Update Submit

August 27, 2015

Conditions

Cocaine-Related Disorders

Keywords

intravenous abuse

Outcome Measures

Primary Outcomes (5)

  • 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

Interventions

FluoxetineDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Please contact site for information.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10023, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Richard Foltin, Ph.D.

    Columbia University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

April 1, 1990

Primary Completion

April 1, 1991

Study Completion

April 1, 1991

Last Updated

August 28, 2015

Record last verified: 2012-12

Locations

US(1)