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Could a monthly shot stop fentanyl overdoses in cocaine and meth users?

NCT ID NCT06633900

Prevention Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a monthly injection of naltrexone can prevent fentanyl overdose in people who use stimulants like cocaine or methamphetamine but do not intentionally use opioids. One hundred participants will either receive the shot or standard harm reduction supplies. Researchers will track how many people stick with the treatment and whether it reduces overdose events.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
naltrexone injection
What this could lead to
If it works, this could offer a new way to prevent opioid overdoses in people who use stimulants and may be unknowingly exposed to fentanyl.
What could go wrong
This is a mid-stage trial with only 100 participants, so results may not apply to everyone. The drug only works if taken consistently, and it cannot reverse an overdose once it happens.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease poisoning acute opioid poisoning prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Overdose accidental

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Center on Substance Use and Health

    RECRUITING

    San Francisco, California, 94102, United States

More trials for these conditions

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