NCT05790252已完成3 期
Using the Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy: A Randomized Controlled Trial (The Patch BRIDGE Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Induction withdrawal severity
研究概览
简要总结
The goal of this clinical trial is to compare buprenorphine patch for induction (starting) of buprenorphine in pregnant patients with opioid use disorder. The main questions it aims to answer are:
- Is there a buprenorphine induction method that results in the least moderate-to-severe opioid withdrawal symptoms in pregnant patients with opioid use disorder?
- Is there a buprenorphine induction method that results in a higher treatment success rate? Under normal circumstances, patients who are planning to start sublingual (under the tongue) buprenorphine for opioid use disorder must first go into withdrawal to start the medication safely. Study participants will be given a buprenorphine patch during the required withdrawal period before starting sublingual treatment, and be surveyed daily by phone to assess their withdrawal symptoms. They will also be followed at prenatal appointments to evaluate treatment success based on urine drug screen results. Researchers will compare patients receiving no buprenorphine patch according to the current standard care protocol.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Viable pregnancy
- •Meet diagnostic criteria for opioid use disorder
- •Receive prenatal care through opioid use disorder specific clinic at our institution
- •Opioid use within 24 hours prior to presentation
- •Desire treatment with buprenorphine
排除标准
- •Patients already receiving treatment for opioid use disorder
- •History of prior induction attempt with buprenorphine
- •Active withdrawal at time of presentation
- •Medical contraindication to buprenorphine
- •Requiring immediate hospitalization
研究组 & 干预措施
Bridge Induction Arm
Experimental
干预措施: Buprenorphine Transdermal Matrix Patch (Drug)
Standard Arm
Placebo Comparator
干预措施: Sham patch (Other)
结局指标
主要结局
Induction withdrawal severity
时间窗: Days 0 through 4
Subjective Opioid Withdrawal Scale (SOWS) scores collected during buprenorphine induction. SOWS scores range from 0-64 with higher scores representing worse withdrawal. Mild withdrawal is defined as scores 0-10, moderate as 11-20, and severe as 21+.
次要结局
- Induction success(Days 0 through 7)
- Recovery success(Days 0 through delivery)
- Treatment adherence(Days 0 through delivery)
研究者
Jeannie Kelly
Associate Professor
Washington University School of Medicine
研究点 (2)
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