Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
- Conditions
- Electronic Cigarette Use
- Interventions
- Device: Standardized research e-cigarette (SREC)
- Registration Number
- NCT05881304
- Lead Sponsor
- Massachusetts General Hospital
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
-
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).
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Delayed SREC provision waitlist control (WLC) Standardized research e-cigarette (SREC) Those in the WLC condition will receive SREC provision after an 8-week delay. Immediate SREC provision (iSREC) Standardized research e-cigarette (SREC) 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.
- Primary Outcome Measures
Name Time Method Cigarettes smoked per day 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 Outcome Measures
Name Time Method Anabasine Baseline 1-Week 8 Change in anabasine - during e-cigarette provision. Change in urine anabasine level (ng/ml)from Baseline 1 to Week 8 between randomized groups.
Breath carbon monoxide Baseline 1-Week 8 Change in expired air carbon monoxide (CO)- during e-cigarette provision. Change in expired air CO (ppm) from Baseline to Week 8 between randomized groups.
Study enrollment Baseline Proportion of those screened identified as eligible. Proportion of those identified as eligible at screening who enroll in trial.
E-cigarette use during e-cigarette provision During the 8 weeks of e-cigarette provision Mean days of e-cigarette use in past 7 days. 1) Number of days of e-cigarette use in past 7 days at Weeks 2, 4, 6, and 8 between randomized groups, and 2) number of days of e-cigarette use in the past 7 days in a pre-post analysis that combines randomized groups
Study completion Baseline 2-12 weeks for iSREC (Baseline 2-20 weeks for WLC) Proportion of patients who complete the trial, defined as completing the final follow-up assessment (12 weeks for iSREC and 20 weeks for WLC) and \>=50% of the study visits.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States