Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633900
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Naltrexone for Overdose Prevention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Extended-Release Naltrexone as Opioid Overdose Pre-Exposure Prophylaxis PrEP in People Using Stimulants Living With or At Risk of HIV
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOD
Brief Summary:
The goal of this clinical trial is to see if an injectable medicine called naltrexone can prevent fentanyl overdose deaths in people who use other drugs cocaine methamphetamine The main questions it aims to answer are
What are the challenges for implementing naltrexone as an overdose prevention strategy
Are injections of naltrexone effective for opioid overdose prevention among people who use stimulants
How often are people who use stimulants and do not intentionally use opioids unintentionally exposed to opioids
Researchers will compare participants to receive the study medication to the usual care group to see if one group experiences fewer opioid overdose events than the other
Participants will be randomized to either receive a monthly injection of naltrexone over six months or receive usual care Usual care includes harm reduction supplies Laboratory procedures will include the collection of urine blood and hair samples for various safety and outcome measure testing
What are the challenges for implementing naltrexone as an overdose prevention strategy
Are injections of naltrexone effective for opioid overdose prevention among people who use stimulants
How often are people who use stimulants and do not intentionally use opioids unintentionally exposed to opioids
Researchers will compare participants to receive the study medication to the usual care group to see if one group experiences fewer opioid overdose events than the other
Participants will be randomized to either receive a monthly injection of naltrexone over six months or receive usual care Usual care includes harm reduction supplies Laboratory procedures will include the collection of urine blood and hair samples for various safety and outcome measure testing
Detailed Description:
This pilot randomized controlled trial aims to evaluate the efficacy of IM naltrexone for opioid overdose prevention among individuals living with HIV PWH and those at risk for HIV who use stimulants The study will concurrently collect data on the feasibility acceptability and preliminary effectiveness of the intervention along with epidemiological data on the prevalence of both intentional and unintentional fentanyl exposure in this population
Participants will be randomly assigned in a 11 fashion to either the intervention group which will receive IM naltrexone or the usual care group which will be provided with safe consumption supplies and intranasal naloxone
Monthly assessments over a 24-week period post-intake followed by a final study visit at 32 weeks will be conducted to measure participants exposure to fentanylopioids utilizing both short-term urine and long-term hair biomarkers as well as self-reported data Adherence to the monthly IM naltrexone injections and the safety profile of the opioid PrEP will also be rigorously evaluated
Participants will be randomly assigned in a 11 fashion to either the intervention group which will receive IM naltrexone or the usual care group which will be provided with safe consumption supplies and intranasal naloxone
Monthly assessments over a 24-week period post-intake followed by a final study visit at 32 weeks will be conducted to measure participants exposure to fentanylopioids utilizing both short-term urine and long-term hair biomarkers as well as self-reported data Adherence to the monthly IM naltrexone injections and the safety profile of the opioid PrEP will also be rigorously evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None