Infusion Laboratory: Protocol 3 (Risperidone) - 4

Cocaine-Related Disorders Clinical Trial

Official title:

Infusion Laboratory: Protocol 3 (Risperidone)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00000339
• Other study ID #: NIDA-3-0010-4
• Secondary ID: Y01-3-0010-4
• Status: Active, not recruiting
• Phase: Phase 1
• First received: September 20, 1999
• Last updated: January 10, 2017
• Start date: June 1996

Study information

• Verified date: June 1996
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• Risperidone

Locations

Country	Name	City	State
United States	Friends Research Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

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