Nalmefene Implant for Opioid Addiction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety of one or two nalmefene implants in healthy individuals, remaining in place for either 4 or 12 weeks. Researchers are studying nalmefene for its potential use in treating opioid addiction by observing how the body absorbs and processes it over time. The trial will guide future studies involving individuals struggling with opioid addiction. It seeks healthy, non-smoking adults who haven't experienced significant medical problems recently and can commit to the study's requirements. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
What prior data suggests that the nalmefene implant is safe for humans?
A previous study tested nalmefene implants in animals and found no safety concerns over a long period. This finding suggests potential safety for humans. Nalmefene, a medication that blocks opioid effects, has been used to treat opioid overdoses in people, effectively reversing the effects without major safety issues. However, like other opioid blockers, nalmefene can cause withdrawal symptoms in individuals dependent on opioids. Reports indicate possible heart-related risks in overdose situations, though these are uncommon. Overall, evidence suggests nalmefene is generally well-tolerated, but further research is needed to confirm this in various settings.12345
Why do researchers think this study treatment might be promising?
Nalmefene implants are unique because they offer a new delivery method for treating opioid addiction. Unlike traditional treatments like methadone or buprenorphine, which require daily oral doses, nalmefene is administered via an implant. This implant provides a consistent release of medication over time, potentially improving adherence and reducing the risk of misuse. Researchers are excited about this approach because it could simplify treatment regimens and help patients maintain sobriety with less effort.
What evidence suggests that nalmefene implants could be effective for opioid addiction?
This trial will evaluate the effectiveness of nalmefene implants for opioid use disorder (OUD). Studies have shown that nalmefene can help individuals with OUD maintain recovery and reduce relapse risk. It blocks opioids' effects in the brain, helping to prevent cravings and overdoses. Nalmefene is already used in some forms, such as injections, to reverse opioid overdoses in emergencies. Research suggests it lasts longer than similar treatments like naloxone, potentially making it useful for long-term OUD management. However, it can cause withdrawal symptoms in those dependent on opioids, so caution is necessary. Participants in this trial will receive either one or two nalmefene implants to assess their effectiveness in managing OUD.12567
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one or two nalmefene implants and are monitored for safety and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after implant removal
What Are the Treatments Tested in This Trial?
Interventions
- Nalmefene
How Is the Trial Designed?
2
Treatment groups
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
ReacX Pharmaceuticals, Inc.
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Citations
Nalmefene Hydrochloride: Potential Implications for Treating ...
Nalmefene hydrochloride is a potent opioid receptor antagonist with unique pharmacological properties that distinguish it from other treatment options for OUD.
Nalmefene Implant for the Long-Term Treatment of Opioid ...
OUD patients in remission have a high rate of relapse to opioid use, and treatment with opioid antagonists like nalmefene can be an effective treatment for ...
Study Examining Use of Nalmefene HCI Injection for Opioid ...
The Clinical Outcomes from Injectable Nalmefene in the Emergency Department (COINED) study is designed to measure the frequency of successful ...
4.
researchgate.net
researchgate.net/publication/379565033_Nalmefene_Hydrochloride_Potential_Implications_for_Treating_Alcohol_and_Opioid_Use_Disorder(PDF) Nalmefene Hydrochloride: Potential Implications for ...
As of 2023, nalmefene is available in the United States as an intranasal spray for reversal of opioid overdose but is not approved for alcohol ...
Nalmefene vs Naloxone for the Treatment of Recurrent ...
The goal of this clinical trial is to compare naloxone to nalmefene for the treatment of opioid overdose in adults. The main questions it aims to answer are ...
Pharmacologic and Clinical Considerations of Nalmefene ...
Desirable outcomes of nalmefene administration include alleviation of respiratory depression, nerve center depression, and hypotension associated with prolonged ...
Opioid Overdose Crisis - Nalmefene HCl injection
Studied in 284 patients presumed to have taken an opioid overdose. Effectively reversed respiratory depression at doses of 0.5 mg to 1 mg. Dose range in ...
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