ED-Initiated Standard Versus High Dose Buprenorphine Induction
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 5
- 主要终点
- Engagement in Treatment (10)
研究概览
简要总结
This study is a multisite double-blind, double-dummy, randomized clinical trial enrolling ED patients with untreated moderate to severe opioid use disorder (OUD) to compare Standard Dose Induction (SDI) and High Dose Induction (HDI) on rates of participation in OUD treatment within 10 days post randomization, and opioid withdrawal symptoms, opioid craving, and use of illicit and non-prescribed drugs.
详细描述
This study will recruit, train, and provide resources to approximately 4 ED systems throughout the U.S. to recruit ED patients presenting with OUD not receiving medications for opioid use disorder (MOUD) as part of an RCT to compare SDI (Zubsolv 5.7/1.4 mg buprenorphine/naloxone* plus 2 placebo tablets) with HDI (three Zubsolv 5.7/1.4 mg* buprenorphine/naloxone tablets) to evaluate rate of participation in OUD treatment within 10 days post-randomization and differences in outcomes of tolerability, opioid withdrawal symptoms, craving, and use of illicit drugs.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
This study is a multi-site double-blind, double-dummy randomized clinical trial. Only the DSC staff overseeing the random assignment schedule, a few designated CCC staff, and the central research staff preparing the study medication will be unblinded; all other study personnel and participants will remain blinded to treatment arm until the nationwide completion of the trial and the database is formally locked. Detailed information on the study procedures regarding the double-blinding will be contained in a standalone Blinding Management Plan and Study Site Blinding Plan. A DSMB will review study data throughout the course of the trial in a blinded fashion (e.g., masked treatment assignments), however they can request to be unblinded at any time.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients enrolled into the study must:
- •Be 18-65 years of age.
- •Be treated in the ED during study screening hours.
- •Meet DSM-5 diagnostic criteria for moderate to severe OUD.
- •Have a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 at enrollment (including 2 objective signs of withdrawal at enrollment).
- •Have a urine toxicology test that is positive for opioids.
- •Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.
排除标准
- •All patients enrolled into the study must not:
- •Have a medical or psychiatric condition that requires hospitalization at the time of index ED visit.
- •Have a known hypersensitivity reaction to buprenorphine/naloxone
- •Be actively suicidal or severely cognitively impaired precluding informed consent.
- •Require ongoing prescription for opioid analgesics.
- •Have a physical exam or reported history consistent with severe liver failure
- •Have a positive urine test for methadone and reported use in the past 72 hours
- •Be a prisoner or in police custody at the time of index ED visit.
- •Be unwilling to follow study procedures (e.g., unwilling to provide permission to contact referral provider/program or unavailable for the follow-up assessments)
- •Have prior enrollment in the current study.
- •Receiving MOUD treatment within the past 7 days.
- •Be pregnant as determined by human gonadotropin (hCG) testing at the index ED visit
- •Have a respiratory rate <8 or oxygen saturation <93%
- •Be a participant in any other clinical trial in which medications are being delivered or the use of an investigational drug or device within the last 30 days
研究组 & 干预措施
High Dose SL-BUP
Participants will receive three 5.7 mg Zubsolv pills; all will be active medication.
干预措施: Buprenorphine (Drug)
Standard SL-BUP
Participants will receive three pills; one 5.7 mg Zubsolv pill with active medication and two placebo pills.
干预措施: Buprenorphine (Drug)
结局指标
主要结局
Engagement in Treatment (10)
时间窗: Within 10 days after study randomization
The proportion of patients in each of the two study arms participating in OUD treatment within 10 days after the study randomization
次要结局
- Craving(Measured daily for 10 days post randomization)
- Substance Use(Measured daily for 10 days post randomization)
- Withdrawal(Measured daily for 10 days post randomization)
- Engagement in Treatment (30)(Within 30 days after randomization)