Recruiting

E-Cigarette with Buprenorphine

Sponsor:

Prisma Health-Upstate

Code:

NCT07202039

Conditions

Tobacco-flavored EC

Sweet-Cooling EC

Sweet Non-cooling EC

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Brief individual counseling sessions

Study Details

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

Conditions

Tobacco-flavored EC

Sweet-Cooling EC

Sweet Non-cooling EC

Study ID

NCT07202039

Start date

Apr 29, 2026

Status verified date

May, 2026

Completion date

Jun 29, 2029

Anticipated

Primary completion date

Mar 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sweet-Cooling EC + Counseling

Those randomized to the intervention group will be provided a free 12-week supply of sweet-cooling electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC.

experimental: Sweet non-cooling EC + Counseling

Those randomized to the intervention group will be provided a free 12-week supply of sweet non-cooling electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC.

active comparator: Tobacco-flavored EC + Counseling

Those randomized to the intervention group will be provided a free 12-week supply of tobacco-flavored electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC.

Interventions

Brief individual counseling sessions

Five brief, individual counseling sessions will provide education, behavioral support, and motivational strategies to facilitate switching from combustible cigarette use to EC

Primary outcome measure

  • Change in cigarettes smoked per day [ Time Frame: Baseline to week 12 ]

Central Contacts and Locations

Central contacts

Irene Pericot-Valverde, PhD

(864)656-4467iperico@clemson.edu

Locations

Addiction Medicine Center

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Alain Litwin, MD

864-455-5648alain.litwin@prismahealth.org

More Information

Sponsor

Prisma Health-Upstate

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

  • Cigarette Smoking
  • Opioid use disorder
  • Burprenorphine
  • Electronic cigarettes
  • Switching
  • Flavors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Prisma Health-Upstate on 2026-05-12.