Comparison of Nalmefene Hydrochloride Injection and Naloxone Hydrochloride Injection for the Treatment of Recurrent Respiratory Depression After Suspected Acute Opioid Overdose in the Emergency Department
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Recurrent respiratory depression
研究概览
简要总结
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:
- Does nalmefene lower the number of doses of medicine participants need to treat opioid overdose?
- When participants are given nalmefene instead of naloxone, do they have fewer complications of opioid overdose such as being admitted to the hospital or having a breathing tube inserted?
Researchers will compare nalmefene to naloxone for the treatment of opioid overdose. Nalmefene and naloxone are both approved medicines to treat opioid overdose.
Participants who are brought to the emergency department after an opioid overdose will be given a dose of either nalmefene or naloxone if their breathing slows down again after an opioid overdose. Participants will:
- Stay in the emergency department for 8 hours after receiving a dose of nalmefene or naloxone.
- Receive a phone call 7 days after their emergency department to check on how they are doing.
Background information:
Naloxone (also known as Narcan) and nalmefene are opioid blocking medicines. When someone overdoses on an opioid, such as heroin or fentanyl, their breathing slows down or stops and they can die. By giving naloxone or nalmefene, the effect of the opioid can be blocked and the person can start breathing again. Naloxone is the most commonly used medicine to reverse an opioid overdose. The effect of naloxone lasts about an hour, and patients may need more than one dose of naloxone to keep them breathing. Sometimes patients overdose, get a dose of naloxone and wake up, and then some time later their breathing slows down again and they need another dose of naloxone. This can happen because the effect of the opioid they took lasts longer than the effect of the naloxone.
The effect of nalmefene lasts longer than naloxone, about four hours. If a person gets nalmefene, their opioid may wear off before the nalmefene wears off and they might not need any more doses of a reversal medicine. Both naloxone and nalmefene are approved medicines for treating opioid overdose.
Often, when a person overdoses on an opioid, someone gives them naloxone right away and then they are brought to the emergency department. In the emergency department, they are watched for several hours to make sure they don't stop breathing again when their naloxone wears off. If they do stop breathing again, they are given another dose of naloxone. In this study, participants will be given either nalmefene or naloxone if their breathing slows down while they are in the emergency department.
详细描述
- Study Design This is an open-label prospective randomized single center study comparing nalmefene to naloxone in the treatment of recurrent respiratory depression from opioids.
- Number of Subjects
We will enroll 37 patients in the nalmefene group and 37 patients in the naloxone group, for a total of 74 patients.
Based upon our feasibility study of naloxone administrations in the ED, 344 patients received naloxone in the ED during a two-year period (2021-2022), corresponding to approximately 14 patients per month. (Note that this is likely their 2nd dose of naloxone, as nearly all patients arrive via EMS and we presume received naloxone by EMS.) We estimate that 75% of patients who receive opioid antagonist treatment during EMS transport or shortly after ED arrival will be capable of providing informed consent in the ED. We estimate that up to 50% may decline to participate. Based on these parameters, we estimate enrolling 5.4 patients per month or 96 subjects over the 18 month enrollment period.
In our power and sample size analysis we estimated we would need to enroll 62 subjects. We added a 20% increase in our sample size to account for subjects that might not stay for the observation period, for a total of 74 patients.
To enroll 74 patients, we will screen 220 patients for eligibility and consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (age ≥ 18 years) presenting to the UNM ED after a suspected acute opioid overdose event requiring at least one dose of naloxone.
排除标准
- •age <18 years
- •non-English speaking
- •unable to or unwilling to provide consent to research participation
- •allergy to naloxone
- •allergy to nalmefene
- •inability to establish IV access
- •prior enrollment in the current study
- •no working phone number for follow-up contact
- •buprenorphine administration during the ED visit prior to enrollment.
- •known pregnancy at the time of enrollment
研究组 & 干预措施
Nalmefene
Nalmefene Rescue Study Arm Treatment:
Subjects will receive study drug if they exhibit respiratory depression (defined as respiratory rate less than 8 breaths per minute and/or end-tidal carbon dioxide measurement of greater than 50 mm Hg) lasting for longer than 10 seconds. Respiratory support with bag-valve mask and/or supplemental oxygen will be provided while the study drug is being prepared. Nalmefene will be administered as per intervention description.
干预措施: Nalmefene Injection (Drug)
Naloxone
Naloxone Rescue Arm Treatment:
Subjects will receive study drug if they exhibit respiratory depression (defined as respiratory rate less than 8 breaths per minute and/or end-tidal carbon dioxide measurement of greater than 50 mm Hg) lasting for longer than 10 seconds. Respiratory support with bag-valve mask and/or supplemental oxygen will be provided while the study drug is being prepared. Naloxone will be administered as per intervention description.
干预措施: Naloxone Injection (Drug)
结局指标
主要结局
Recurrent respiratory depression
时间窗: Within 8 hours of intervention
Recurrent respiratory depression requiring repeat treatment with an opioid antagonist. Respiratory depression is defined as a respiratory rate (RR) \<8 breaths per minute or end-tidal CO2 (ETCO2)\> 50 mm Hg.
次要结局
- Precipitated withdrawal(Within 8 hours of intervention)
- Serious adverse event(Within 8 hours of intervention)
研究者
Caitlin Bonney
Assistant Professor of Emergency Medicine
University of New Mexico