Cigarette Smoking Among Young Adults

University of Oklahoma171 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

171

Conditions

Cigarette Smoking Smoking Behaviors

Interventions

Very low nicotine cigarette: mentholOTHER

Participants will be randomized to smoke either menthol non-menthol flavored very low nicotine cigarettes in their home environment for 7 days and in the laboratory first and then crossed over to receive the opposite intervention. The study consists of two treatment periods of 7 days separated by a 1 week wash-out period

Very low nicotine cigarette: non-mentolOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 34 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Ages18 to 34; 2. Smoke cigarettes "somedays" or "everyday" for at least the past 3-months; 3. A strong preference for menthol cigarettes (i.e., smoke menthol \>80% of the time); and 4. Ability to read English at an 8th grade level or higher; 5. No immediate plans to quit smoking. Exclusion Criteria: 1. Current use of nicotine replacement therapy (NRT); 2. Pregnant or planning to become pregnant, or currently breastfeeding; 3. Past or current self-reported clinically significant heart disease or hypertension, or other smoking-related disease (by history) that preclude successful study completion; 4. Serious psychiatric disorder; 5. Inability to abstain from nicotine/tobacco products; 6. Strong preference for non-menthol cigarettes (smoke non-menthol \> 80% of the time)

Locations (1)

Health Promotion Research Center

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Puff Topography

total inhalation volume from smoking behavior in the laboratory

Time frame: Baseline to week 4

Ratings of Psychological Reward

Subjective response to smoking, as measured by self-reported psychological reward (scale) of the modified Cigarette Evaluation Scale, administered after smoking. The minimum value is 1 and the maximum value is 7; with 7 indicating greater psychological reward.

Time frame: Baseline to week 9

Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs)

Purchasing of non-menthol very low nicotine cigarettes in the Experimental Tobacco Marketplace (ETM) task 1 and 2. Product units purchased per cigarette price displayed in the ETM, displayed as milligrams of nicotine. Prices are $0.12, $0.25, $0.5, $1, $2, $4, $8, and $16 per cigarette. Data are presented as units purchased on a log scale, per recommended best practices.

Time frame: Assessed during tobacco purchase tasks completed at week 5

Secondary Outcomes

Exhaled CO Boost

measures expired alveolar carbon monoxide (CO) level before smoking and after smoking; measured in parts per million (ppm)

Time frame: Baseline to week 4

Data from ClinicalTrials.gov

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