Naltrexone for Overdose Prevention

ConditionOverdose Accidental

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of California, San Francisco

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

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),

Trial design

Design model

Parallel

Treatments tested in this trial

IM naltrexone
Drug
The study drug is an intramuscular injection of naltrexone (380mg), administered every 4 weeks via an injection in the ventrogluteal region.
Usual Care
Behavioral
Participants assigned to usual care will receive a harm reduction bundle in clinic. It will include the following components: 1) intranasal naloxone 4mg x 2, 2) participant choice of safer consumption kits based on substances and route used (specific materials for inhaled use vs. injecting, based on common use practices in the region), 3) fentanyl test kits with 2 lateral flow assays per package along with instructions to minimize false positive results, and 4) information about universal overdose precautions (behavioral modifications to optimize safety like using in the presence of others, use a test dose of new substances, etc.)

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

Acceptability

The primary outcome is the acceptability of IM naltrexone as opioid PrEP, which the study investigators will quantitatively assess via retention in treatment at 24 weeks and proportion of on-time injections during the study period. The investigators will consider 50% of enrolled participants completing 3 or more injections to meet a minimum standard of intervention uptake.

Time frame

6 months

Secondary outcomes

Effectiveness

The study investigators will also evaluate incident opioid overdose, which will be defined as 1) fatal overdose, 2) overdose requiring emergency medical services (including first-responder evaluation, emergency department visit, hospitalization), or 3) participant report of overdose or sedation responding to community-delivered naloxone. This will allow the investigators to define unintentional opioid overdose rates among PWH or individuals at risk only seeking to use stimulants (with inadvertent exposure to opioids) while also evaluating possible effectiveness of IM naltrexone as an augmented harm reduction strategy.

Time frame

6 months

Safety: Occurrence of Grade 2 or Worse Adverse Events

Our primary safety outcome is proportion of participants with grade 2 or worse adverse events (such as nausea, vomiting, laboratory abnormalities, neurologic symptoms).

Time frame

6 months

Other outcomes

Opioid exposure

As an additional biomarker-based method of evaluating possible opioid overdose prevention, the investigators will analyze participant hair for opioids and compare this to the measure of opioid overdose during the same time period. Hair samples can be analyzed for opioids or methamphetamines as a cumulative metric of exposure. If a participant on IM naltrexone is found to have fentanyl-positive hair (indicating exposure in the last 1-3 months depending on length analyzed) but no clinical overdose, this may suggest an unrecognized exposure, and possible protection by naltrexone. Hair can also be used to evaluate temporal trends in stimulant use quantity to record reduced use in the intervention arm vs. usual care arm.

Time frame

6 months

Viral suppression

HIV viral suppression will be recorded at baseline and time of exit from the trial to evaluate whether increased engagement in clinic-based harm reduction efforts has a positive effect upon successful HIV control.

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

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