Switching smokers with opioid use disorder to e-cigarettes
Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
This study is testing if switching smokers with opioid use disorder to a special e-cigarette can help them reduce their smoking while they continue their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05881304 on ClinicalTrials.gov |
What this trial studies
This pilot randomized waitlist-controlled trial aims to evaluate the feasibility and preliminary effects of substituting a standardized research e-cigarette (SREC) for traditional cigarettes among individuals receiving medication for opioid use disorder who are not ready to quit smoking. The study will involve 40 adults who smoke daily and are stable on buprenorphine treatment, randomly assigned to receive the SREC immediately or after an 8-week delay. Outcomes will include changes in tobacco use behavior, biomarkers, cigarette dependence, withdrawal symptoms, and short-term health effects. Participants will be monitored for a total of 12 weeks to assess the impact of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who smoke at least 10 cigarettes per day and are stable on buprenorphine treatment for opioid use disorder but are not ready to quit smoking.
Not a fit: Patients who are pregnant, breastfeeding, or using other nicotine products, as well as those with unstable psychiatric or medical conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help reduce cigarette smoking among individuals with opioid use disorder, potentially improving their overall health.
How similar studies have performed: While the specific approach of using SREC for this population is novel, similar studies have shown promise in reducing smoking rates among other populations.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Joanna M Streck, PhD — Massachusetts General Hospital
- Study coordinator: Joanna M Streck, PhD
- Email: jstreck@mgh.harvard.edu
- Phone: 617-643-9977
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.