NCT00000309

Brief Summary

The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study measures incorporate an appropriate integration of behavioral and neurobiological indices.

Trial Health

57
Monitor

Trial Health Score

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

Timeline
Completed

Started Aug 1994

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 1994

Completed
5.1 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
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2000

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

5.4 years

First QC Date

September 20, 1999

Last Update Submit

July 23, 2015

Conditions

Keywords

cocaine abuse, cocaine addiction

Outcome Measures

Primary Outcomes (3)

  • Analog mood scales

  • POMS

  • EPS sx

Interventions

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Please contact site for information.

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Sponsors & Collaborators

Study Sites (1)

Brown University School of Medicine

Providence, Rhode Island, 2906, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Lawrence Price, M.D.

    Brown University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Human Behavior

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

August 1, 1994

Primary Completion

January 1, 2000

Study Completion

January 1, 2000

Last Updated

July 24, 2015

Record last verified: 2015-07

Locations