Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC (NCT05881304) | Clinical Trial Compass
CompletedNot Applicable
Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
United States41 participantsStarted 2024-06-03
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.