Expired Study
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Los Angeles, California 90025


Purpose:

The purpose of this study is to evaluate clinical safety and pharmacological efficacy in the treatment of cocaine dependence, to evaluate impact of treatment on craving, and to correlate evidence of baseline neurotoxic damage of cocaine with treatment outcome and clinical side-effects.


Criteria:

Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.


Study is Available At:


Original ID:

NIDA-3-0010-7


NCT ID:

NCT00000342


Secondary ID:

Y01-3-0010-7


Study Acronym:


Brief Title:

Risperidone for the Treatment of Cocaine Dependence - 7


Official Title:

Risperidone for the Treatment of Cocaine Dependence


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Drug Abuse (NIDA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Parallel Assignment, Masking:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Walter Ling, M.D.
Principal Investigator
Friends Research Institute, Inc.

Study Dates

Start Date:July 1996
Completion Date:September 1997
Completion Type:Actual
Primary Completion Date:August 1997
Primary Completion Type:Actual
Verification Date:June 1997
Last Changed Date:January 11, 2017
First Received Date:September 20, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Risperidone

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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