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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Nalmefene Implant in Healthy Subjects
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- 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