Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cigarette
  • Smoking
Type
Interventional
Phase
Early Phase 1
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 21 years and 125 years
Gender
Both males and females

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 ci...

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.

Tracking Information

NCT #
NCT04740008
Collaborators
Not Provided
Investigators
Principal Investigator: Dana Mowls Carroll, Ph.D., M.P.H Masonic Cancer Center, University of Minnesota