Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Ayesha Appa, MD (ucsf)
Headshot of Ayesha Appa
Ayesha Appa

Description

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.

Official Title

Extended-Release Naltrexone as Opioid Overdose Pre-Exposure Prophylaxis (PrEP) in People Using Stimulants Living With or At Risk of HIV

Details

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 1:1 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 fentanyl/opioids, 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.

Keywords

Overdose Accidental, stimulants, cocaine, methamphetamine, overdose prevention, naltrexone, fentanyl exposure, Drug Overdose, IM naltrexone

Eligibility

You can join if…

Open to people ages 18 years and up

  1. at-risk for HIV or living with HIV
  2. stimulant use disorder (by SCID-5) or positive urine drug test for cocaine, amphetamine, or methamphetamine in last 6 months AND report at least 10 days of stimulant use/month,
  3. able to provide informed consent,
  4. English-speaking,
  5. age 18 years old or greater.

You CAN'T join if...

  1. prescribed or non-prescribed opioid use (including newly diagnosed opioid use disorder by SCID-5),
  2. receipt of long-acting injectable naltrexone for other indications in past 30 days,
  3. planned surgery in next 6 months,
  4. Childs-Pugh Class C cirrhosis,
  5. AST or ALT elevations (over 5 times greater than upper limit of normal),
  6. persons who are pregnant or breastfeeding,
  7. increased risk of bleeding (thrombocytopenia <50 x 109/L, coagulopathy, or therapeutic anticoagulation),
  8. buttock implants or fillers, or
  9. known hypersensitivity to naltrexone or its diluents.

Location

  • Center on Substance Use and Health
    San Francisco California 94102 United States

Lead Scientist at University of California Health

  • Ayesha Appa, MD (ucsf)
    Dr. Ayesha Appa is an Assistant Professor of Medicine in the Division of HIV, Infectious Diseases, and Global Medicine at San Francisco General Hospital and a clinician investigator triply board-certified in Infectious Diseases, Addiction Medicine, and Internal Medicine.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06633900
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated