NCT04740008

Impact of Low Nicotine Cigarette Messaging on Perceptions and Cigarette Choices

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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

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: 1. Virtual Zoom Screening - Completed after telephone screen: Informed consent is obtained and then an interview where data is collected and eligibility is further assessed. 2. 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. 3. Virtual Zoom Home Session - Completed after curbside and if eligible based on curbside: Surveys assessing main outcome variables assessed. 4. 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.

Conditions

• Smoking
• Cigarette

Interventions

Type	Name	Description
DRUG	Low Nicotine Content Cigarettes	Low Nicotine Content Cigarettes 0.4 mg/g nicotine; 9 mg tar Other Name: Reduced Nicotine Content Cigarettes
OTHER	Control message	Participants will read control message
OTHER	Test message	Participants will read test message

Timeline

• Start date: 2021-04-20
• Primary completion: 2022-08-24
• Completion: 2022-08-24
• First posted: 2021-02-05
• Last updated: 2024-02-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study