Impact of Low Nicotine Cigarette Messaging on Perceptions and Cigarette Choices

Study Overview
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Brief Summary
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The purpose of this research is to evaluate the effects of low nicotine content cigarette (LNC) educational messaging on perceptions of low nicotine cigarettes, tobacco/nicotine product choice preferences (hypothetical), LNC cigarette subjective ratings, and LNC cigarette abuse liability among adult smokers.

Detailed Description
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This randomized single-site study will assess the subject's risk perceptions and hypothetical tobacco product choices based on their exposure to an educational messaging condition related to nicotine content in cigarettes. Subjects (N=40 in each group) will be given a pack of low nicotine content cigarettes (LNC; 0.4 mg/g) and will be randomly assigned to read one of two messaging conditions on low nicotine cigarettes. Smokers will undergo a telephone screening to assess eligibility, then move on to the next steps of the study depending on eligibility: Virtual Zoom Screening - Completed after telephone screen: Informed consent is obtained and then an interview where data is collected and eligibility is further assessed. Curbside Visit - Completed after the screening and if eligible: Breath test, and if necessary a urine test, is performed to assess smoking levels and urine pregnancy test is attained (if applicable). If eligible, randomization to messaging condition occurs and participants provided a pack of low nicotine content cigarettes. Virtual Zoom Home Session - Completed after curbside and if eligible based on curbside: Surveys assessing main outcome variables assessed. Follow-up - Completed 1 week after the virtual Zoom session: Interview where assessment of health and product usage is assessed. Except for the initial telephone screening, participants will receive compensation for each part of the study.

Official Title
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Impact of Low Nicotine Cigarette Messaging on Risk Perceptions and Hypothetical Tobacco and Nicotine Product Choices.

Conditions
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Smoking, Cigarette

Intervention / Treatment
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* Drug: Low Nicotine Content Cigarettes
* Other: Control message
* Other: Test message


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female At least 21 years of age Biochemically confirmed smoker Exclusion Criteria: Unstable health condition Unstable medications Pregnant or nursing Unreliable access to a computer, smart phone or tablet without working camera and internet access for telehealth visits and online questionnaires

Ages Eligible for Study
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Minimum Age: 21 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control message on low nicotine cigarettes<br> | Drug: Low Nicotine Content Cigarettes<br>* Low Nicotine Content Cigarettes 0.4 mg/g nicotine; 9 mg tar Other Name: Reduced Nicotine Content Cigarettes<br>Other: Control message<br>* Participants will read control message<br>|
| Experimental: Test message on low nicotine cigarettes<br> | Drug: Low Nicotine Content Cigarettes<br>* Low Nicotine Content Cigarettes 0.4 mg/g nicotine; 9 mg tar Other Name: Reduced Nicotine Content Cigarettes<br>Other: Test message<br>* Participants will read test message<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants that choose ANDS or no tobacco | Proportion of participants who select to use ANDS or no tobacco if LNC cigarettes were the only cigarettes available will be compared in arm 1 versus arm 2 | Within 17 days of virtual screening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Nicotine Content, Educational Messaging, Cigarette, Smoking