NCT00000310

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 Jan 1996

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 1996

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1996

Completed
3.6 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

January 16, 2017

Status Verified

January 1, 1996

Enrollment Period

2 months

First QC Date

September 20, 1999

Last Update Submit

January 13, 2017

Conditions

Cocaine-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (4)

  • Urine toxicology for cocaine

  • Analog mood scales

  • POMS

  • EPS sx

Interventions

RisperidoneDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Cocaine abuse or dependence

You may not qualify if:

  • Dependence on other drugs. Major psychiatric illness

Contact the study team to confirm eligibility.

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
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

January 1, 1996

Primary Completion

March 1, 1996

Study Completion

March 1, 1996

Last Updated

January 16, 2017

Record last verified: 1996-01

Locations

US(1)