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Infusion Laboratory: Protocol 3 (Risperidone) - 4

Primary Purpose

Cocaine-Related Disorders

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Risperidone
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine dependence

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Friends Research Institute

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 20, 1999
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000339
Brief Title
Infusion Laboratory: Protocol 3 (Risperidone) - 4
Official Title
Infusion Laboratory: Protocol 3 (Risperidone)
Study Type
Interventional

2. Study Status

Record Verification Date
June 1996
Overall Recruitment Status
Unknown status
Study Start Date
June 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
cocaine dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Single
Enrollment
13 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Risperidone
Primary Outcome Measure Information:
Title
Evidence of change in neurotoxicity based on chore
Title
Degree of drug craving
Title
History, incidence and amount of drug use
Title
Type and severity of stimulant withdrawal symptoms
Title
Characterization of study population
Title
Population incidence of symptoms of depression, po
Title
Frequency and intensity of drug use and sexual beh
Title
Evidence of change in subjective responses to coca
Title
Clinical physiological response to cocaine challen
Title
Degree to which study medication influences change

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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 nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Ling, M.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friends Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Infusion Laboratory: Protocol 3 (Risperidone) - 4

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