Viewing Study NCT04587115



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Last Modification Date: 2024-10-26 @ 1:47 PM
Study NCT ID: NCT04587115
Status: COMPLETED
Last Update Posted: 2020-10-14
First Post: 2020-08-19

Brief Title: Reducing the Abuse Liability of Prescription Opioids
Sponsor: The University of Texas Health Science Center at San Antonio
Organization: The University of Texas Health Science Center at San Antonio

Study Overview

Official Title: Reducing the Abuse Liability of Prescription Opioids
Status: COMPLETED
Status Verified Date: 2020-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Opioid commonly called narcotic pain medicines are after marijuana the most commonly abused substances in the United States Patients who take opioids for legitimate reasons may become addicted for example as many as 1 in 4 patients meet the criteria for current opioid dependence It is very important that a way is found to provide pain relief while minimizing the addiction potential of these widely used pain medications

The study aim to find out if the use of another type of medication given in addition to an opioid will reduce the addiction potential of the opioid

The study is trying to find out if the ability of the opioid to relieve pain is changed when given with the other medication and to see if the euphoric sensation or liking of the opioid pain medication is reduced when taken with the other medication
Detailed Description: This study involves the use of an investigational combination of drugs Oxycodone with Risperidone and Oxycodone with Ziprasidone are called Investigational because the US Food Drug Administration FDA has not approved these drug combinations for the purpose of this study Individually each of these drugs is approved by the FDA for other reasons ie oxycodone as a painkiller while risperidone and ziprasidone are approved as anti-psychotic medications but the administration of these drugs together has not been studied before or been approved by the FDA for this purpose

This is the first study involving humans to examine the safety of this combination of drugs and how they work together The goal of the study is to find out what effects good andor bad it has on people who take them Because the combination has not been studied in humans before information about the safety and effectiveness is incomplete and all of the side effects are not yet known

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None