NCT00000187

Brief Summary

The purpose of this study is to assess ritanserin as a pharmacotherapy for cocaine dependence.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 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

July 1, 1992

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1994

Completed
5.3 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

1.9 years

First QC Date

September 20, 1999

Last Update Submit

May 26, 2015

Conditions

Cocaine-Related Disorders

Keywords

Cocaine Dependenceritanserin

Outcome Measures

Primary Outcomes (2)

  • Cocaine use

  • Cocaine craving

Interventions

RitanserinDRUG

Eligibility Criteria

Age28 Years - 47 Years
Sexmale
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)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104 6178, United States

Location

Related Publications (1)

  • Cornish JW, Maany I, Fudala PJ, Ehrman RN, Robbins SJ, O'Brien CP. A randomized, double-blind, placebo-controlled study of ritanserin pharmacotherapy for cocaine dependence. Drug Alcohol Depend. 2001 Jan 1;61(2):183-9. doi: 10.1016/s0376-8716(00)00140-x.

    PMID: 11137283BACKGROUND

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Ritanserin

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinonesPyrimidines

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

July 1, 1992

Primary Completion

June 1, 1994

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

US(1)