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
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
475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.
This study's planned enrollment of 90 is close to the median of 96 across 406 interventional studies indexed under Cigarette Smoking.
Browse Cigarette Smoking studies →Prisma Health-Upstate is the lead sponsor of 76 studies on the registry; 7 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Five brief, individual counseling sessions will provide education, behavioral support, and motivational strategies to facilitate switching from combustible cigarette use to EC
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
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
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
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
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
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
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
Plan to share: Undecided
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Prisma Health-Upstate