CClinicalTrials.gg
RecruitingNCT07202039SWITCHUpdated May 12, 2026

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

An interventional study of Brief individual counseling sessions in Tobacco-flavored EC, Sweet-Cooling EC and Sweet Non-cooling EC, sponsored by Prisma Health-Upstate. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Prisma Health-Upstate · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Tobacco-flavored EC
  • Sweet-Cooling EC
  • Sweet Non-cooling EC

Keywords

  • Cigarette Smoking
  • Opioid use disorder
  • Burprenorphine
  • Electronic cigarettes
  • Switching
  • Flavors
03

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study 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.

    Behavioral: Brief individual counseling sessions

  • 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.

    Behavioral: Brief individual counseling sessions

  • 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.

    Behavioral: Brief individual counseling sessions

Interventions

  • BehavioralBrief 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

05

What researchers measure

Primary outcomes

  1. Change in cigarettes smoked per day

    The average change in mean CPD on a 7-day TLFB assessment from baseline (week 0) to weeks 12

    Time frame: Baseline to week 12

Secondary outcomes

  1. Change in cigarettes smoked per day

    The average change in mean CPD on a 7-day TLFB assessment from baseline (week 0) to week 24

    Time frame: Baseline to week 24

  2. Percentage of participants with a ≥50% reduction in CPD

    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

    Time frame: Baseline to weeks 12 and 26

  3. Switching

    Proportion of participants reporting exclusive EC use and no CC use on a 7-day TLFB with CO \<6 ppm.

    Time frame: Weeks 12 and 24

  4. Partial Switching

    Proportion of participants reporting both EC and CC use on a 7-day TLFB with a ≥50% reduction in CPD.

    Time frame: Weeks 12 and 24

  5. 7-Day CC Abstinence

    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.

    Time frame: Weeks 12 and 26

  6. Change in carbon monoxide levels

    Change in exhaled CO levels from baseline (week 0) to weeks 12 and 26 (continuous variable).

    Time frame: Baselone to weeks 12 and 26

06

Study locations

1 of 1 sites recruiting
  • Addiction Medicine Center
    Greenville, South Carolina 29605, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07202039
Lead sponsor
Prisma Health-Upstate
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Irene Pericot-Valverde (Assistant Professor, Clemson University) — Principal investigator
First posted
Oct 1, 2025
Start date
Apr 29, 2026
Primary completion
Mar 30, 2029 (estimated)
Completion
Jun 29, 2029 (estimated)
Last update
May 12, 2026

Study contacts

Irene Pericot-Valverde, PhD
Contact
iperico@clemson.edu
(864)656-4467

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion