A Pilot Randomized Controlled Trial of Low-dose Buprenorphine Initiation for Opioid Use Disorder
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Recruitment Feasibility: Percentage of subjects assessed who enroll in the clinical trial.
研究概览
简要总结
The purpose of this study is to test whether low-dose buprenorphine initiation for treatment of opioid use disorder is safe and effective.
详细描述
After being informed about the study and potential risks, all participants will be given written informed consent. Eligible participants will be randomized in a 1:1 ratio to an 8-day low-dose buprenorphine initiation protocol or treatment as usual, and conduct study visits at baseline and weeks 2 and 4. The investigators will also provide participants with mobile phones to collect real-time data on withdrawal, anxiety, craving and substance use through electronic Ecological Momentary Assessment (EMA) technology.
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Any gender, aged 18 years or greater
- •Opioid Use Disorder (based on Diagnostic and Statistical Manual- Version 5 criteria)
- •Ability to take sublingual medication
- •Willingness to adhere to the assigned buprenorphine initiation regimen
- •Fluency in English or Spanish
- •For participants of reproductive potential: agreement to use highly effective contraception during study participation
排除标准
- •Use of FDA-approved medications for opioid use disorder treatment (within 7 days prior to screening), including methadone, buprenorphine, or naltrexone
- •Diagnosis of Alcohol Use Disorder, severe or Benzodiazepine Use Disorder, severe (based on Diagnostic and Statistical Manual- Version 5 criteria)
- •Severe untreated mental illness, meaning psychosis or suicidality
- •Presence of an acute or chronic medical condition that would make participation medically hazardous
- •Pregnancy or lactation
- •Known allergic reactions to buprenorphine or naloxone
- •Inability to consent due to cognitive impairment
研究组 & 干预措施
Low-dose initiation
Participants randomized to low-dose buprenorphine initiation will start low-dose buprenorphine-naloxone (bup-nx) according to an at-home, 8-day protocol (below). Participants in the low-dose buprenorphine initiation arm will be allowed to continue taking the full opioid agonist that they were taking at the time of enrollment until they reach a therapeutic dose of buprenorphine-naloxone.
Day 1: 0.5 mg once; Day 2: 0.5 mg every 12 hours; Day 3: 1 mg every 12 hours; Day 4: 2 mg every 12 hours; Day 5: 3mg every 12 hours; Day 6: 4 mg every 12 hours; Day 7: 6 mg every 12 hours; Day 8: 8 mg every 12 hours
干预措施: buprenorphine-naloxone (Drug)
Treatment as usual
Participants randomized to treatment as usual will start buprenorphine-naloxone (bup-nx) following standard clinical guidelines for two-day, at-home initiation.
干预措施: buprenorphine-naloxone (Drug)
结局指标
主要结局
Recruitment Feasibility: Percentage of subjects assessed who enroll in the clinical trial.
时间窗: At baseline study visit (time zero)
This pilot study is designed to establish the feasibility of a future, full-powered clinical trial. The primary question this study seeks to answer is whether primary care patients with opioid use disorder are willing to enroll in a clinical trial of low-dose inductions. The study will aim to enroll 25% of subjects who are assessed. "Assessed" is defined as having been referred to the study staff. Enrollment is defined as having been randomized to a treatment arm.
次要结局
- Protocol Feasibility: Proportion of participants who follow adequate fidelity to the low-dose initiation study protocol.(From baseline to day 8)
- Non-prescribed opioid use(From baseline to 6-week study visit)
- Number of participants who uptake buprenorphine treatment at 2 weeks(2-week study visit)
- Number of participants retained in buprenorphine treatment at 6 weeks(6-week study visit)
- Withdrawal severity(From baseline to 2-week study visit)
- Precipitated withdrawal(From baseline to 2-week study visit)
- Mild vs Mod-Severe Withdrawal symptoms(From baseline to 2-week study visit)