Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Cigarettes smoked per day
研究概览
简要总结
The goal of this study is to conduct a pilot randomized waitlist-controlled trial to assess the feasibility, acceptability, and preliminary effects of substituting the NIDA standardized research e-cigarette (SREC) for combusted cigarettes in MOUD-TUD who are not ready to quit smoking. A waitlist controlled RCT using a mixed-methods sequential explanatory design will investigate the impact of SREC provision on: 1) tobacco use behavior (e.g., cigarettes per day [primary outcome], SREC use), 2) biomarkers (e.g., carbon monoxide, anabasine), 3) cigarette dependence and withdrawal, and 4) short-term health effects and tolerability (e.g., respiratory symptoms, substance use). In the proposed RCT, N=40 adults stable on MOUD with buprenorphine who report daily smoking recruited from MGH primary care practices will be randomly assigned to receive the SREC for 8 weeks, either immediately (iSREC), or after an 8-week delay (waitlist control [WLC]). They will be followed an additional 4 weeks after SREC provision ends (to 12 weeks in iSREC and 20 weeks in WLC).
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
- 是
入选标准
- •18 years of age
- •Report daily cigarette smoking (>=10 cigarettes per day in the past week)
- •Not ready to quit smoking (not planning to quit in the next 30 days)
- •Willing to try e-cigarettes
- •In stable buprenorphine (BUP) treatment for opioid use disorder at an Massachusetts General Hospital-affiliated primary care clinic (in treatment for >=3 months without changes in BUP dose in the past 2 weeks and planning to remain on current BUP treatment for >=3 months).
排除标准
- •Pregnant or breastfeeding
- •Using non-cigarette nicotine or tobacco products (e.g., e-cigarettes, cigarillos) recently (>3 days in past 30 days)
- •Report past 30-day use of behavioral or pharmacologic smoking cessation aids
- •Deemed inappropriate for participation by their OUD provider
- •Have an unstable psychiatric (e.g., past month suicidal ideation, active psychosis) or medical condition (e.g., life expectancy <1 year).
研究组 & 干预措施
Immediate SREC provision (iSREC)
Those randomized to the iSREC group will be provided a free 8-week supply of standardized research e-cigarettes (SRECs) and asked to try to switch completely to the SREC.
干预措施: Standardized research e-cigarette (SREC) (Device)
Delayed SREC provision waitlist control (WLC)
Those in the WLC condition will receive SREC provision after an 8-week delay.
干预措施: Standardized research e-cigarette (SREC) (Device)
结局指标
主要结局
Cigarettes smoked per day
时间窗: Baseline 2 to 8 weeks
Change in cigarettes smoked per day (CPD) between randomized groups. Change in mean number of CPD in the past 7 days from Baseline 2 to Week 8 comparing between randomized groups (iSREC group vs. WLC).
次要结局
- Anabasine(Baseline 1-Week 8)
- Breath carbon monoxide(Baseline 1-Week 8)
- Study enrollment(Baseline)
- E-cigarette use during e-cigarette provision(During the 8 weeks of e-cigarette provision)
- Study completion(Baseline 2-12 weeks for iSREC (Baseline 2-20 weeks for WLC))
研究者
Joanna M. Streck, Ph.D.
Assistant Professor in Psychiatry
Massachusetts General Hospital