Suspended

Risperidone and Cocaine Interaction: Assessing Clinical Safety

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Study Aim

This phase 1 study aims to evaluate the clinical safety of Risperidone when interacting with cocaine, focusing on changes in neurotoxicity, drug craving, drug use history, stimulant withdrawal symptoms, and physiological responses to cocaine challenge in individuals using cocaine.

What is being tested

Risperidone

Drug
Who is being recruted

Mental Disorders+1

+ Substance-Related Disorders

+ Chemically-Induced Disorders

From 21 to 50 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: June 1996
See protocol details

Summary

Principal SponsorNational Institute on Drug Abuse (NIDA)
Last updated: January 11, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1996

Actual date on which the first participant was enrolled.

This study focuses on the drug Risperidone and its interaction with cocaine. It aims to understand the safety aspects of using Risperidone, both alone and when combined with cocaine. The study also wants to find out how taking Risperidone before cocaine might affect the user's feelings and physical responses to cocaine. This research is important because it could help improve treatment options for people who struggle with cocaine use. During this study, participants will receive Risperidone and cocaine under controlled conditions. The study will measure changes in neurotoxicity, drug craving, and the history and amount of drug use. It will also evaluate withdrawal symptoms from stimulants, the characteristics of the study population, and the frequency and intensity of drug use and sexual behavior. Additionally, it will observe how Risperidone might influence changes in the user's subjective experience of cocaine, their physical response to a cocaine challenge, and the degree of depression symptoms in the population.

NCT00000339
Principal SponsorNational Institute on Drug Abuse (NIDA)
Last updated: January 11, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

13 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSubstance-Related DisordersChemically-Induced DisordersCocaine-Related Disorders

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Friends Research Institute

Los Angeles, United StatesOpen Friends Research Institute in Google Maps
SuspendedOne Study Center