Cigarette Smoking, E-Cigarette Use, Smoking Cessation
Conditions
Brief summary
The purpose of this research study is to understand whether concurrent treatment for cigarettes and e-cigarettes in which an individual quits both products at the same time (QUIT-C) or sequential treatment in which an individual quits cigarettes first followed by e-cigarettes is more effective for quitting both products. The study will also compare the effect of treatment on health-related biomarkers. All participants will receive varenicline, a medication used to treat tobacco use dependence, counseling, and cessation resources (i.e., links to text-based support, self-change booklet). Varenicline helps to reduce cravings for tobacco use and decreases the pleasurable effects of cigarettes and other tobacco products.
Detailed description
Inclusion/exclusion criteria will be determined via initial online screening and then confirmed with tele-video/phone call final screening. Non-pregnancy verification will be ascertained via remote pregnancy test. All participants will be asked to provide assessments (as described below) throughout the sampling process to assess cigarette smoking and e-cigarette use behavior, varenicline use, and use of cessation resources. This is a 12 week, open-label study of varenicline.
Interventions
DRUGVarenicline
Varenicline prescription will follow the standard induction period: varenicline 0.5 mg once per day for Days 1-3, varenicline 0.5 mg twice per day for Days 4-7, then varenicline 1 mg twice per day (when varenicline reaches peak efficacy for tobacco cessation). Participants will remain on varenicline for 12 weeks total. Dose adjustments (e.g., reduction to 0.5 mg twice per day if 1 mg is not well tolerated) will be allowed at the discretion of the clinical pharmacist/APRN/physician.
BEHAVIORALCounseling
Tobacco Treatment Service clinicians will deliver weekly counseling sessions, monitor participants for adverse events, and record participants' weekly cigarette and e-cigarette use. At the first counseling session clinicians will review medication proper use instructions, and potential side effects and strategies to address them at the first counseling session. Study medication refills will be distributed at 4-week intervals. Sessions will focus on quit plan preparation, supportive and practical cessation counseling, resetting quit dates, and relapse prevention.
BEHAVIORALGuided Self-Change Booklets
The booklet includes information on how to reduce and quit both cigarettes and e-cigarettes on their own, how to prevent relapse, how to set a quit date, and how to enroll in text-based support resources.
Sponsors
Yale University
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English literate * Report cigarette smoking, and e-cigarette use for at least the past 3 months * Smoke 5 or more cigarettes per day * Report e-cigarette use for at least 14 days in the past month * Interested in quitting both products in the next month and willing to set a quit date.
Exclusion criteria
* Vulnerable Populations: Investigators will not be enrolling vulnerable populations, specifically pregnant women, children, prisoners, or institutionalized individuals * Investigators also will not enroll participants incapable of providing their own consent. The rationale will be provided to the individual as well as his or her family members. Referrals for further evaluation, including urgent or emergent evaluation, will be made as needed and clinically warranted. * Investigators will exclude anyone currently using any smoking cessation services and/or FDA pharmacotherapies. * Verification of Non-Pregnancy: Females ages \<55 will be given a commercially available pregnancy test to verify non-pregnancy. A female of child-bearing age that is currently pregnant or breastfeeding or report an unwillingness to use effective birth control (i.e., abstinence, IUD, implant, sterilization, pill, patch, ring, or barrier method such as condoms with spermicide) for the duration of the study will not be enrolled. * Individuals using other tobacco or nicotine products besides cigarettes and e-cigarettes \> once per week in the last 30 days will be excluded. * Investigators will exclude individuals with medical contraindications for varenicline use (i.e., severe renal impairment and unstable cardiac history) * Medical Conditions: Investigators will not enroll anyone with a current, serious uncontrolled medical/psychiatric condition (e.g., a condition that required a hospitalization or intensive outpatient treatment in the past year) based on review by Study Physician that would increase risk of severe adverse events and/or interfere with study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cigarette Abstinence at Week 12- Carbon Monoxide | Week 12 | 7-day point prevalence cigarette abstinence at Week 12, biochemically verified by breath carbon monoxide |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| E-Cigarette Abstinence at Week 12- Cotinine | Week 12 | 7-day point prevalence e-cigarette abstinence at Week 12, biochemically verified by urine cotinine |
| Number of cigarettes smoked per day | Baseline up to week 12 | Number of cigarettes smoked per day assessed by self-report |
| Percent days of e-cigarette usage | Baseline up to week 12 | Percent days of e-cigarette usage assessed by self-report |
| Biomarkers of tobacco-related harm exposure | Baseline up to week 12 | Primary urinary biomarkers of tobacco-related harm exposure will be assessed including NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol), a tobacco carcinogen linked to lung cancer risk. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLisa Fucito, PhD
Yale University
Outcome results
None listed