Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
Overview
- Phase
- N/A
- Intervention
- Standardized research e-cigarette (SREC)
- Conditions
- Electronic Cigarette Use
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Cigarettes smoked per day
- Status
- Completed
- Last Updated
- 16 days ago
Overview
Brief Summary
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).
Investigators
Joanna M. Streck, Ph.D.
Assistant Professor in Psychiatry
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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).
Arms & Interventions
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.
Intervention: Standardized research e-cigarette (SREC)
Delayed SREC provision waitlist control (WLC)
Those in the WLC condition will receive SREC provision after an 8-week delay.
Intervention: Standardized research e-cigarette (SREC)
Outcomes
Primary Outcomes
Cigarettes smoked per day
Time Frame: 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).
Secondary Outcomes
- 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))