Nalmefene Implant Safety Study in Healthy Volunteers

This study is looking at the safety of one or two nalmefene implants in healthy adults. Nalmefene is a drug being studied for opioid abuse and addiction. Researchers want to see how well people tolerate the implants and how long the drug stays in the body. They will be checking for any side effects (Adverse Events) for up to 24 weeks, and also looking at mood and depression scores. This information will help plan future studies for people with opioid addiction. You may be eligible if you are a healthy non-smoker between 18 and 55 years old with a healthy BMI.

Study design
This is a Phase 1, open-label study involving 24 healthy volunteers. It will compare the effects of one or two nalmefene implants.
What's involved
You would have a screening period, then up to 16 visits over about 18 weeks, including up to 8 nights in the clinic. The implant would be inserted on Day 1 and removed around Week 12.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for Adverse Events for up to 24 weeks after implantation, and for mood and depression on Day 1 and Day 2.

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NCT07325279

Nalmefene Implant in Healthy Subjects

Recruiting
PHASE1Ages 18+InterventionalTreatment
ReacX Pharmaceuticals, Inc.
~24 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:1 Nalmefene implant2 Nalmefene implants

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Adverse Events (AEs) after implantation with 1 or 2 nalmefene implants.
Measured over Day 1 up to Week 12 or Week 24
+2 more outcomes measured
Opioid Abuse and Addiction
1 sites across 1 states
North Carolina1

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Eligibility criteria

Exclusion

Subjects to whom any of the following applies will be excluded from the study:
  • Number of participants with Adverse Events (AEs) after implantation with 1 or 2 nalmefene implants.Day 1 up to Week 12 or Week 24
  • Columbia-Suicide Severity Rating Scale (C-SSRS)Day 1 and Day 2

    Questionnaire

  • Montgomery-Asberg Depression Rating Scale (MADRS)Day 1 and Day 2

    Questionnaire