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| ID | Type | Description | Link |
|---|---|---|---|
| 2P50CA196530-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QUIT-C (Concurrent) | Experimental | Treatment in this arm will emphasize concurrent cessation of cigarettes and e-cigarettes. All participants will receive 12-weeks of varenicline, weekly individual counseling, and access to cessation resources including a guided self-change booklet and links to free text-based support. Counseling and cessation resources will emphasize concurrent cessation. |
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| QUIT-S (Sequential) | Experimental | Treatment in this arm will focus on cessation of cigarettes followed sequentially by cessation of e-cigarettes. All participants will receive 12-weeks of varenicline, weekly individual counseling, and access to cessation resources including a guided self-change booklet and links to free text-based support. Counseling and cessation resources will emphasize sequential cessation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarette Abstinence at Week 12- Carbon Monoxide | 7-day point prevalence cigarette abstinence at Week 12, biochemically verified by breath carbon monoxide | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| E-Cigarette Abstinence at Week 12- Cotinine | 7-day point prevalence e-cigarette abstinence at Week 12, biochemically verified by urine cotinine | Week 12 |
| Number of cigarettes smoked per day | Number of cigarettes smoked per day assessed by self-report |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Fucito, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D000072137 | Vaping |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D015438 |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Counseling | Behavioral | 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. |
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| Guided Self-Change Booklets | Behavioral | 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. |
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| Baseline up to week 12 |
| Percent days of e-cigarette usage | Percent days of e-cigarette usage assessed by self-report | Baseline up to week 12 |
| Biomarkers of tobacco-related harm exposure | 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. | Baseline up to week 12 |
| Health Behavior |
| D011810 | Quinoxalines |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |