RECRUITING

Naltrexone for Overdose Prevention

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-04-10
Study Completion:2027-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06633900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. at-risk for HIV or living with HIV
  2. 2. stimulant use disorder (by DSM-V) 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. 3. able to provide informed consent,
  4. 4. English-speaking,
  5. 5. age 18 years old or greater.
  1. 1. prescribed or non-prescribed opioid use (including newly diagnosed opioid use disorder by DSM-V),
  2. 2. receipt of long-acting injectable naltrexone for other indications in past 30 days,
  3. 3. planned surgery in next 6 months,
  4. 4. moderate, severe or chronic liver disease (AST, ALT ≥ 5 times the upper limit of normal or symptoms of current liver disease),
  5. 5. persons who are pregnant or breastfeeding,
  6. 6. increased risk of bleeding (thrombocytopenia \<50 x 109/L, coagulopathy, or therapeutic anticoagulation), or
  7. 7. known hypersensitivity to naltrexone or its diluents.

Contacts and Locations

Study Contact

Ayesha Appa, MD
CONTACT
628-206-7839
ayesha.appa@ucsf.edu
Xochitl Luna Marti, MPH
CONTACT
628-217-6235
xochitl.lunamarti@sfdph.org

Principal Investigator

Ayesha Appa, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Ayesha Appa, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-10
Study Completion Date2027-04-15

Study Record Updates

Study Start Date2025-04-10
Study Completion Date2027-04-15

Terms related to this study

Keywords Provided by Researchers

  • stimulants
  • cocaine
  • methamphetamine
  • overdose prevention
  • naltrexone
  • fentanyl exposure

Additional Relevant MeSH Terms

  • Overdose Accidental