Infusion Laboratory: Protocol 3 (Risperidone) - 4

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ClinicalTrials.gov Identifier: NCT00000339

Recruitment Status : Unknown

Verified June 1996 by National Institute on Drug Abuse (NIDA).
Recruitment status was: Active, not recruiting

First Posted : September 21, 1999

Last Update Posted : January 11, 2017

Sponsor:

Information provided by:

National Institute on Drug Abuse (NIDA)

Tracking Information

First Submitted Date ^ICMJE

September 20, 1999

First Posted Date ^ICMJE

September 21, 1999

Last Update Posted Date

January 11, 2017

Study Start Date ^ICMJE

June 1996

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Evidence of change in neurotoxicity based on chore
Degree of drug craving
History, incidence and amount of drug use
Type and severity of stimulant withdrawal symptoms
Characterization of study population
Population incidence of symptoms of depression, po
Frequency and intensity of drug use and sexual beh
Evidence of change in subjective responses to coca
Clinical physiological response to cocaine challen
Degree to which study medication influences change

Original Primary Outcome Measures ^ICMJE

History, incidence and amount of drug use
Type and severity of stimulant withdrawal symptoms
Characterization of study population
Population incidence of symptoms of depression, po
Frequency and intensity of drug use and sexual beh
Evidence of change in subjective responses to coca
Clinical physiological response to cocaine challen
Degree to which study medication influences change
Degree of drug craving
Evidence of change in neurotoxicity based on chore

Change History

Complete list of historical versions of study NCT00000339 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Infusion Laboratory: Protocol 3 (Risperidone) - 4

Official Title ^ICMJE

Infusion Laboratory: Protocol 3 (Risperidone)

Brief Summary

The purpose of this study is to evaluate clinical safety issues pertaining to risperidone, to cocaine and to its interaction, and to determine how pretreatment with risperidone modifies the subjective as well as physiological effects of cocaine.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment

Condition ^ICMJE

Cocaine-Related Disorders

Intervention ^ICMJE

Drug: Risperidone

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Enrollment ^ICMJE

Original Enrollment ^ICMJE

Same as current

Study Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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 nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Sex/Gender

Sexes Eligible for Study:

All

Ages

21 Years to 50 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00000339

Other Study ID Numbers ^ICMJE

NIDA-3-0010-4
Y01-3-0010-4

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Walter Ling, M.D.

Friends Research Institute, Inc.

PRS Account

National Institute on Drug Abuse (NIDA)

Verification Date

June 1996

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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