Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- BUP Treatment Uptake
研究概览
简要总结
Investigators will test a novel protocol for starting BUP (buprenorphine-naloxone) treatment. The BUP microdose induction protocol has participants start very low doses of BUP without stopping other opioids that they are taking. The treatment as usual (TAU) has participants stop other opioids and experience opioid withdrawal before starting BUP. Investigators propose to test BUP microdose inductions vs. TAU in a randomized controlled trial.
详细描述
Investigators will conduct a hybrid type 1 effectiveness-implementation study, using a pragmatic, open-label, randomized controlled trial (RCT). Investigators will randomize 270 hospitalized patients with (a) chronic pain and (b) opioid misuse or opioid use disorder (OUD) to a 5-day BUP microdose induction protocol (without stopping full agonists) or 2-day standard induction (with stopping full agonists), and then link participants to outpatient BUP treatment when they are released from the hospital. Study assessment visits will occur at baseline, 1 week, and 1, 3, and 6 months. Assessments will include interviews and urine drug tests to determine whether participants start BUP, continue BUP, have improvements in pain and decrease illicit opioid use. During induction and 3-months of follow-up, investigators will also collect data on mobile devices to assess opioid withdrawal, opioid craving, pain, and anxiety. These data will allow investigators to assess whether BUP microdosing targets of engagement-opioid- and pain-related symptoms-mediate OUD outcomes. Exploratory analyses will also examine pain as a trigger for opioid relapse.
Aim 1: To test the effectiveness of BUP microdose induction (vs. TAU) on OUD outcomes.
H1: The microdose arm (vs. TAU) will have better BUP treatment uptake and retention, and less illicit opioid use.
H2: Improvements in H1 will be mediated by opioid- and pain-related symptoms.
Aim 2: To test the effectiveness of microdosing (vs. TAU) on pain outcomes. H3: The microdose arm (vs. TAU) will have less pain intensity and interference, and improved quality of life.
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
- •Age > 18 years
- •Opioid misuse or OUD
- •Chronic pain
- •Currently taking opioids
- •Fluency in English or Spanish
- •Planned hospitalization for ≥ 48 hours
排除标准
- •Current OUD treatment (BUP, methadone, naltrexone)
- •Severe alcohol or benzodiazepine use disorder
- •Hypersensitivity to BUP or naloxone
- •Pain due to malignancy
- •Severe untreated mental illness (suicidality, psychosis)
- •Pregnancy
- •Unable to consent due to pain or cognitive impairment
研究组 & 干预措施
Treatment As Usual (TAU)
Participants in this arm will receive standard BUP induction protocol.
干预措施: TAU (Drug)
BUP microdose induction
Participants in this arm will receive a novel BUP microdose induction protocol.
干预措施: BUP microdose induction (Drug)
BUP microdose induction
Participants in this arm will receive a novel BUP microdose induction protocol.
干预措施: Linkage to outpatient BUP treatment (Behavioral)
Treatment As Usual (TAU)
Participants in this arm will receive standard BUP induction protocol.
干预措施: Linkage to outpatient BUP treatment (Behavioral)
结局指标
主要结局
BUP Treatment Uptake
时间窗: 7 days
The percentage of participants who start BUP treatment, defined as receiving BUP 7 days after the baseline visit, will be reported for each arm.
次要结局
- Pain Intensity(3 months)
- Pain Interference(3 months)
- Illicit Opioid Use(1, 3, and 6 months)
- Pain Intensity(3 months)
- BUP Retention in Care(1, 3, and 6 months)