NCT00000274

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of flupenthixol and haloperidol for cocaine dependence in individuals with schizophrenia/schizoaffective illness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 1997

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

March 1, 1997

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1999

Completed
5 months 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 12, 2017

Status Verified

November 1, 2016

First QC Date

September 20, 1999

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related DisordersSubstance-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (4)

  • Side effects

  • Drug use

  • Psychiatric symptoms

  • Cocaine craving

Interventions

FlupenthixolDRUG

Eligibility Criteria

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

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Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Cocaine-Related DisordersSubstance-Related Disorders

Interventions

Flupenthixol

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ThioxanthenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsXanthenesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Herbert Kleber, M.D.

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

March 1, 1997

Study Completion

May 1, 1999

Last Updated

January 12, 2017

Record last verified: 2016-11

Locations

US(1)