Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 41 people enrolled
- Started
- 3 Jun 2024
- Ended
- 31 Dec 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Standardized research e-cigarette (SREC)
- Record updated
- 21 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Have an unstable psychiatric (e.g., past month suicidal ideation, active psychosis) or medical condition (e.g., life expectancy <1 year)
- 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
Where in United States
- Massachusetts General HospitalBoston, United States
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Immediate SREC provision (iSREC)Treatment being tested
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.
Treatment: Standardized research e-cigarette (SREC)
- Delayed SREC provision waitlist control (WLC)Existing treatment, for comparison
Those in the WLC condition will receive SREC provision after an 8-week delay.
Treatment: Standardized research e-cigarette (SREC)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 21 October 2026