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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
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04740008
Enrollment
64
Registered
2021-02-05
Start date
2021-04-20
Completion date
2022-08-24
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking, Cigarette

Keywords

Low Nicotine Content, Educational Messaging, Cigarette, Smoking

Brief 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.

Interventions

DRUGLow Nicotine Content Cigarettes

Low Nicotine Content Cigarettes 0.4 mg/g nicotine; 9 mg tar Other Name: Reduced Nicotine Content Cigarettes

Participants will read control message

OTHERTest message

Participants will read test message

Sponsors

Masonic Cancer Center, University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of participants that choose ANDS or no tobaccoWithin 17 days of virtual screeningProportion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026