Effects of E-cigs vs Pouches on Cigarette Smoking and Addiction
Study Details
Study Description
Brief Summary
The study will recruit an anticipated 256 adults who currently smoke cigarettes and report a willingness to try switching to alternative, non-combustible products. Participants will be randomized to receive either e-cigarettes or nicotine pouches for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco/unflavored available or tobacco/unflavored only available, and nicotine concentration is either higher (5% Vuse Alto e-cig, 6mg Zyn pouch) or lower (3% Vuse Alto e-cig, 3mg Zyn pouch). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. Participants will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided. The investigators expect to observe which products and constituents lead to greater smoking reduction.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The study includes 5 visit and assessments over 6 weeks. The intake visit will take approximately 60 minutes and subsequent visits will take approximately 30 minutes. The study is proposed to run for 5 years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: E-cigarettes Adults who smoke cigarettes will be randomized to receive e-cigarettes for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco/unflavored available or tobacco/unflavored only available, and nicotine concentration is either higher (5% Vuse Alto e-cig) or lower (3% Vuse Alto e-cig). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. They will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided. |
Behavioral: Vuse Alto E-cigarette with 3% Nicotine with Menthol and Tobacco Flavors
Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.
Behavioral: Vuse Alto E-cigarette with 3% Nicotine with Tobacco Flavor Only
Flavor availability is tobacco/unflavored only with lower nicotine concentration.
Behavioral: Vuse Alto E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors
Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.
Behavioral: Vuse Alto E-cigarette with 5% Nicotine with Tobacco Flavor Only
Flavor availability is tobacco/unflavored only with higher nicotine concentration.
|
| Experimental: Nicotine Pouches Adults who smoke cigarettes will be randomized to receive nicotine pouches for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco/unflavored available or tobacco/unflavored only available, and nicotine concentration is either higher (6mg Zyn pouch) or lower (3mg Zyn pouch). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. They will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided. |
Behavioral: Zyn Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors
Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.
Behavioral: Zyn Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only
Flavor availability is tobacco/unflavored only with lower nicotine concentration.
Behavioral: Zyn Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors
Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.
Behavioral: Zyn Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only
Flavor availability is tobacco/unflavored only with higher nicotine concentration.
|
Outcome Measures
Primary Outcome Measures
- Aim 1: Average number of cigarettes smoked per day [From baseline to week 4]
Participants will report the total number of cigarettes consumed each day using a well-validated timeline follow-back (TLFB) interview method to assess number of cigarettes smoked per day continuously over the 4-week observational period for each product condition.
- Aim 2: Percent of days using non-combustible product [From baseline to week 4]
Participants will report daily use of e-cigarettes or nicotine pouches using a well-validated timeline follow-back (TLFB) interview method continuously over the 4-week observational period to determine the total percent days use of the non-combustible product for each product condition.
Secondary Outcome Measures
- Aim 1: Percent of days abstinent from cigarettes [From baseline to week 4]
Participants will report the total number of cigarettes consumed each day using a well-validated timeline follow-back (TLFB) interview method to assess number of cigarettes smoked per day continuously over the 4-week observational period to determine the total percent days abstinent (smoke-free) for each product condition.
- Aim 1: Biochemically verified 7 day point-prevalent abstinence from cigarettes [Week 4]
Complete switching from cigarettes will be assessed at the end of the study period using self-reported TLFB methods and biochemical verification with expired breath carbon monoxide (CO) testing (CO < 5ppm) to determine rates of 7-day point-prevalent abstinence
- Aim 1: Cigarette Dependence [From baseline to week 4]
Cigarette dependence will be measured using the 4-item PROMIS® Short Form v1.0 - Smoking Nicotine Dependence for All Smokers 4a. Each item is scored from 1-5 with the range of scores from 4-20 with higher scores representing greater cigarette dependence.
- Aim 2: Average use of non-combustible products per day [From baseline to week 4]
Participants will report daily e-cigarette and nicotine pouch quantity and frequency consumed using a well-validated timeline follow-back (TLFB) interview method to use continuously over the 4-week observational period for each product condition.
- Aim 2: Continued use of non-combustible products [Week 4 to 6]
Participants will report daily use of e-cigarettes or nicotine pouches using a well-validated timeline follow-back (TLFB) interview method to determine the total percent days use of the non-combustible product for each product condition during the follow-up period.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
21+ years old
-
English literate
-
Currently smoking cigarettes, biochemically confirmed
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Not planning a smoking cessation attempt or to use smoking cessation pharmacotherapies (NRT, bupropion, varenicline) in the next month.
Exclusion Criteria:
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Currently using any smoking cessation services and/or pharmacotherapies
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Currently pregnant or breastfeeding
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Significant current medical or psychiatric condition
-
Known hypersensitivity to propylene glycol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale University | New Haven | Connecticut | United States | 06520 |
Sponsors and Collaborators
- Yale University
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Lisa Fucito, PhD, Yale University
- Principal Investigator: Krysten Bold, PhD, Yale University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2000035286
- U54DA036151