Overdose Accidental study: IM naltrexone
Official title Naltrexone for Overdose Prevention
ClinicalTrials.gov ID: NCT06633900
What this study is testing
What is IM naltrexone?
An investigational once‑monthly intramuscular injection being studied for preventing opioid overdose in people who use stimulants.
Also referred to as naltrexone.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if monthly naltrexone injections can reduce opioid overdose events and what challenges exist in using this approach.
- Who it's for
- People who use stimulants like cocaine or methamphetamine and are at risk of accidental fentanyl exposure.
- What's involved
- Participants receive a monthly injection of naltrexone for six months or usual care with harm‑reduction supplies. They also provide urine, blood, and hair samples for safety and outcome tests.
- Time commitment
- The study lasts six months, with monthly injections or visits and regular sample collection.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- at-risk for HIV or living with HIV
- 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...
- able to provide informed consent,
- English-speaking,
- age 18 years old or greater.
You likely can't join if
- prescribed or non-prescribed opioid use (including newly diagnosed opioid use disorder by DSM-V),
- receipt of long-acting injectable naltrexone for other indications in past 30 days,
- planned surgery in next 6 months,
- moderate, severe or chronic liver disease (AST, ALT ≥ 5 times the upper limit of normal or symptoms of current liver disease),
- persons who are pregnant or breastfeeding,
- increased risk of bleeding (thrombocytopenia \<50 x 109/L, coagulopathy, or therapeutic anticoagulation),
See the full eligibility criteria
- at-risk for HIV or living with HIV
- 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,
- able to provide informed consent,
- English-speaking,
- age 18 years old or greater.
- prescribed or non-prescribed opioid use (including newly diagnosed opioid use disorder by DSM-V),
- receipt of long-acting injectable naltrexone for other indications in past 30 days,
- planned surgery in next 6 months,
- moderate, severe or chronic liver disease (AST, ALT ≥ 5 times the upper limit of normal or symptoms of current liver disease),
- persons who are pregnant or breastfeeding,
- increased risk of bleeding (thrombocytopenia \<50 x 109/L, coagulopathy, or therapeutic anticoagulation),
- known hypersensitivity to naltrexone or its diluents, or
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.