NCT00000189

Brief Summary

The purpose of this study is to test antidepressant medication, gepirone, as a pharmacotherapy for cocaine dependent subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1990

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 1991

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 1991

Completed
8.6 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

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

1.1 years

First QC Date

September 20, 1999

Last Update Submit

May 26, 2015

Conditions

Cocaine-Related Disorders

Keywords

Cocaine DependenceGepirone

Interventions

GepironeDRUG

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104 6178, United States

Location

Related Publications (1)

  • Jenkins SW, Warfield NA, Blaine JD, Cornish J, Ling W, Rosen MI, Urschel H 3rd, Wesson D, Ziedonis D. A pilot trial of gepirone vs. placebo in the treatment of cocaine dependency. Psychopharmacol Bull. 1992;28(1):21-6.

    PMID: 1609038BACKGROUND

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

gepirone

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • James Cornish, M.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

January 1, 1990

Primary Completion

February 1, 1991

Study Completion

February 1, 1991

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

US(1)