Cigarette Smoking Among Young Adults

Study Overview
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Brief Summary
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This study will examine perceptions and smoking behavior of menthol and non-menthol very low nicotine cigarettes in young adult smokers. The aims are to examine perceptions and smoking behavior in the laboratory and in the natural environment. A separate sub-sample of men and women who identify as LGBTQ2S+ will also be recruited.

Detailed Description
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This proposal includes three different aspects of assessment for menthol smoking young adults. The laboratory phase includes three separate sessions of laboratory smoking through a machine designed to measure puff behavior; the EMA phase includes 21 days of monitoring smoking behavior and attitudes related to smoking when smoking one's usual brand cigarette, the assigned menthol low nicotine cigarette, and the assigned non-menthol low nicotine cigarette in the participant's natural environment. The order of administration of smoking menthol and non-menthol VLNC will be counterbalanced. There will be a 7-day wash-out period between each 7-day period of using low nicotine cigarettes. The final phase includes a virtual marketplace where participants can purchase and use the research cigarettes in the context of other available tobacco products on the market, or purchase no tobacco products at all. There will be a final assessment, over the phone or in-person, 30-days after the final study visit (at week 8), to assess tobacco use behavior and attitudes about tobacco use. Participants will be enrolled for approximately 9 weeks. Week 1 will consist of smoking one's usual brand of cigarette in the laboratory and then in their home environment for 7-days. Week 2 will consist of smoking the first very low nicotine cigarette in the home environment for 7 days and then in the laboratory. Week three will consist of a 7-day wash-out period where participants can smoke their usual brand again, as they normally would. Week 4 will consist of smoking the second very low nicotine cigarette at home for 7 days and then in the laboratory. Week 5 will consist of returning to the laboratory for a final study visit and complete a hypothetical experimental tobacco marketplace. One month (4 weeks) after the final study visit (week 9), participants will complete a 30-day follow-up of cigarette smoking and other tobacco use behavior.

Official Title
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Impact of a Reduced Nicotine Standard on Young Adult Appeal for Menthol and Non-menthol Cigarettes

Conditions
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Cigarette Smoking, Smoking Behaviors

Intervention / Treatment
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* Other: Very low nicotine cigarettes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages18 to 34; Smoke cigarettes somedays or everyday for at least the past 3-months; A strong preference for menthol cigarettes (i.e., smoke menthol >80% of the time); and Ability to read English at an 8th grade level or higher; No immediate plans to quit smoking. Exclusion Criteria: Current use of nicotine replacement therapy (NRT); Pregnant or planning to become pregnant, or currently breastfeeding; Past or current self-reported clinically significant heart disease or hypertension, or other smoking-related disease (by history) that preclude successful study completion; Serious psychiatric disorder; Inability to abstain from nicotine/tobacco products; Strong preference for non-menthol cigarettes (smoke non-menthol > 80% of the time)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Menthol very low nicotine cigarette<br>Participants will smoke menthol flavored very low nicotine cigarettes in their home environment for 7 days. At the end of 7-days, they will also smoke one menthol flavored very low nicotine cigarette in the laboratory. | Other: Very low nicotine cigarettes<br>* Participants will be randomized to smoke menthol and non-menthol flavored very low nicotine cigarettes in their home environment for 7 days and in the laboratory<br>|
| Other: Non-menthol very low nicotine cigarette<br>Participants will smoke non-menthol flavored very low nicotine cigarettes in their home environment for 7 days. At the end of 7-days, they will also smoke one non-menthol flavored very low nicotine cigarette in the laboratory. | Other: Very low nicotine cigarettes<br>* Participants will be randomized to smoke menthol and non-menthol flavored very low nicotine cigarettes in their home environment for 7 days and in the laboratory<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in puff topography | total inhalation volume from smoking behavior in the laboratory | Baseline to week 4 | 
| Change in Cigarette Evaluation Scale (CES) | Subjective response to smoking | Baseline to week 9 | 
| Hypothetical Purchasing of Tobacco Products | Purchasing of cigarettes and other tobacco products across changing prices in Experimental Tobacco Marketplace task | Assessed during tobacco purchase tasks completed at week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CO boost | measures expired alveolar carbon monoxide level | Baseline to week 4 |