Sweet-Cooling EC, Sweet Non-cooling EC, Tobacco-flavored EC
Conditions
Keywords
Cigarette Smoking, Opioid use disorder, Burprenorphine, Electronic cigarettes, Switching, Flavors
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
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
Sponsors
Prisma Health-Upstate
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
CONTACTIrene Pericot-Valverde, PhD
Outcome results
None listed