Using naltrexone injections to prevent overdose deaths in stimulant users

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of injectable naltrexone in preventing fentanyl overdose deaths among individuals who use stimulants like cocaine and methamphetamine. Participants will be randomly assigned to receive either monthly naltrexone injections or usual care, which includes harm reduction supplies. The study will assess the feasibility, acceptability, and preliminary effectiveness of naltrexone, alongside collecting data on opioid exposure in this population. Monthly assessments will track participants' exposure to opioids and adherence to the treatment over a 24-week period.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Ayesha Appa, MD — University of California, San Francisco
• Study coordinator: Ayesha Appa, MD
• Email: ayesha.appa@ucsf.edu
• Phone: 628-206-7839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Support for families grieving an overdose loss

  This project will test a peer-led grief support program called RIVER to help adults who lost a loved one to an unintentional drug overdose within the past year.

  Recruiting at 3 sites Rand · Birmingham, Alabama and 3 other locations · NCT06854757

• Guiding Optimal Blood Pressure in Peritoneal Dialysis

  This pilot tests whether aiming for a lower systolic blood pressure target (<120 mmHg) is feasible and practical for adults with end-stage kidney disease on peritoneal dialysis, compared to a <140 mmHg target.

  Recruiting at 2 sites University of California, San Francisco · San Francisco, California and 2 other locations · NCT07910773

• Understanding how the orbitofrontal cortex guides approach vs. avoidance in depression

  This study tests how different parts of the orbitofrontal cortex influence whether people pursue rewards or risk loss, and whether this pattern is altered in Major Depressive Disorder.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07896343

• LIFU to Help Sleep and Amyloid Reduction in Older Adults with Cognitive Impairment

  A wearable ultrasound device (ATTN201) is being tested to see if it’s safe and easy to use for people 65 and older with mild cognitive impairment and amyloid buildup.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07866768

• Tics and Tourette's: Accelerated TBS rTMS in Teens and Adults

  This study tests whether a short, intensive course of inhibitory theta burst stimulation can help reduce tic symptoms in teens and young adults with Tourette syndrome or chronic tic disorders.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07839377

• Compare two bladder medicines and placebo for urgency incontinence in older women

  This study tests whether tolterodine ER or mirabegron help with urinary and aging-related outcomes in older women with urgency-predominant incontinence, compared with placebo.

  Recruiting Phase 4 University of California, San Francisco · San Francisco, California · NCT07829029

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.