Electronic Cigarettes as a Harm Reduction Strategy Among People With Opioid Use Disorder on Buprenorphine

Not Applicable

Not yet recruiting

• Conditions: Tobacco-flavored EC; Sweet-Cooling EC; Sweet Non-cooling EC

• Registration Number: NCT07202039
• Lead Sponsor: Prisma Health-Upstate

Brief Summary

This project aims to investigate the impact of e-cigarette flavors and usage patterns on achieving harm-reduction milestones in a sample of cigarette smokers with opioid use disorder who are taking buprenorphine

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-23
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Study Start: 2026-01-05
• Primary Completion: 2029-10-27
• Study Completion: 2030-02-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in cigarettes smoked per day	Baseline to week 12	The average change in mean CPD on a 7-day TLFB assessment from baseline (week 0) to weeks 12

Secondary Outcome Measures

Name	Time	Method
Change in cigarettes smoked per day	Baseline to week 24	The average change in mean CPD on a 7-day TLFB assessment from baseline (week 0) to week 24
Percentage of participants with a ≥50% reduction in CPD	Baseline to weeks 12 and 26	The rate of participants achieving an average ≥50% reduction in CPD from baseline (week 0) to weeks 12 and 26, based on a 7-day TLFB
Switching	Weeks 12 and 24	Proportion of participants reporting exclusive EC use and no CC use on a 7-day TLFB with CO \<6 ppm.
Partial Switching	Weeks 12 and 24	Proportion of participants reporting both EC and CC use on a 7-day TLFB with a ≥50% reduction in CPD.
7-Day CC Abstinence	Weeks 12 and 26	Percentage of participants with biochemically verified 7-day abstinence (1 = abstinent, 0 = non-abstinent). Defined as self-reported no CC use on a 7-day TLFB with CO \<6 ppm.
Change in carbon monoxide levels	Baselone to weeks 12 and 26	Change in exhaled CO levels from baseline (week 0) to weeks 12 and 26 (continuous variable).

Trial Locations

Locations (1)

Addiction Medicine Center; 🇺🇸 Greenville, South Carolina, United States