NCT06633900 Naltrexone for Overdose Prevention
| NCT ID | NCT06633900 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University of California, San Francisco |
| Condition | Overdose Accidental |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-04-10 |
| Primary Completion | 2027-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-04-10 with a primary completion date of 2027-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. at-risk for HIV or living with HIV 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. able to provide informed consent, 4. English-speaking, 5. age 18 years old or greater. Exclusion Criteria: 1. prescribed or non-prescribed opioid use (including newly diagnosed opioid use disorder by DSM-V), 2. receipt of long-acting injectable naltrexone for other indications in past 30 days, 3. planned surgery in next 6 months, 4. moderate, severe or chronic liver disease (AST, ALT ≥ 5 times the upper limit of normal or symptoms of current liver disease), 5. persons who are pregnant or breastfeeding, 6. increased risk of bleeding (thrombocytopenia \<50 x 109/L, coagulopathy, or therapeutic anticoagulation), 7. known hypersensitivity to naltrexone or its diluents, or 8. any other reason (e.g. comorbid medical conditions, adherence concerns, lack of interest in naltrexone, etc.) that judged by the study team's discretion, would impede the participant from successfully completing the trial.
Contact & Investigator
Ayesha Appa, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06633900 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Overdose Accidental. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06633900 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06633900 currently recruiting?
Yes, NCT06633900 is actively recruiting participants. Contact the research team at ayesha.appa@ucsf.edu for enrollment information.
Where is the NCT06633900 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06633900 clinical trial?
NCT06633900 is sponsored by University of California, San Francisco. The principal investigator is Ayesha Appa, MD at University of California, San Francisco. The trial plans to enroll 100 participants.