Risperidone and Cocaine Interaction: Assessing Clinical Safety
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.
Risperidone
Mental Disorders+1
+ Substance-Related Disorders
+ Chemically-Induced Disorders
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.13 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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
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