E-cigarette flavor options as harm reduction for people on buprenorphine
Electronic Cigarettes as a Harm Reduction Strategy Among People With Opioid Use Disorder on Buprenorphine
This project will test whether switching to different flavored e-cigarettes helps adults with opioid use disorder who are taking buprenorphine reduce harms from smoking cigarettes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Prisma Health-Upstate Academic / other |
| Locations | 1 site (Greenville, South Carolina) |
| Trial ID | NCT07202039 on ClinicalTrials.gov |
What this trial studies
This interventional project enrolls adult daily cigarette smokers with opioid use disorder who are stable on buprenorphine and willing to try e-cigarettes. Participants are offered e-cigarettes in different flavor categories (tobacco, sweet-cooling, sweet non-cooling) alongside brief individual counseling and monitored for use patterns and harm-reduction milestones such as reduced combustible cigarette use and carbon monoxide levels. The study uses biochemical verification (exhaled CO) at enrollment and follow-up visits and collects smartphone-enabled usage and self-report data to track switching and sustained use. Outcomes will compare how flavor and use patterns influence switching from combustible cigarettes in this clinical population.
Who should consider this trial
Good fit: Adults aged 21 or older who smoke at least 5 cigarettes per day for a year, have opioid use disorder, are stable on buprenorphine, have exhaled CO ≥6 ppm, can use a smartphone, and are willing to switch to e-cigarettes and attend study visits.
Not a fit: People currently trying to quit cigarettes, those already using e-cigarettes frequently or other tobacco products heavily, pregnant or breastfeeding individuals, or those with uncontrolled psychiatric or medical contraindications are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could help people with opioid use disorder who smoke reduce their use of combustible cigarettes and related health harms by switching to e-cigarettes they prefer.
How similar studies have performed: Previous studies in general smoking populations have shown e-cigarettes can reduce combustible cigarette use, but flavor-focused interventions and data specifically in people with opioid use disorder on buprenorphine are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Age ≥21 years * Smoke ≥5 CPD for ≥1 year * Daily CC smoker * Willing to switch to EC * Exhaled CO ≥6 ppm * Diagnosed with OUD * Stable on bupropion treatment * In good physical and mental health * Able to use a smartphone * Willing to participate in all study components * Able to provide informed consent Exclusion Criteria * Interested in quitting CC (contemplation stage of change) * Use of EC on ≥4 of the past 30 days * Use of other tobacco products (e.g., cigars, smokeless tobacco) on ≥9 days of the past 30 days * Use of nicotine replacement therapy, smoking cessation medication, or a cessation attempt in the past 30 days * Hypertension * Medical condition that would contraindicate participation * Meet DSM-V criteria for major depressive episode, psychotic episode, or manic episode * Current suicidal ideation or suicide attempt in the past year * Psychiatric hospitalization in the past year * Contemplating pregnancy, currently pregnant, or breastfeeding * Unable to speak and/or read English
Where this trial is running
Greenville, South Carolina
- Addiction Medicine Center — Greenville, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Irene Pericot-Valverde, PhD
- Email: iperico@clemson.edu
- Phone: (864)656-4467
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.