Impact of Low Nicotine Cigarette Messaging on Perceptions and Cigarette Choices

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04740008
• Other study ID #: SPH-2020-29384
• Secondary ID: 2020LS214
• Status: Completed
• Phase: Early Phase 1
• Start date: April 20, 2021
• Est. completion date: August 24, 2022

Study information

• Verified date: February 2024
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 24, 2022
• Est. primary completion date: August 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette
• Smoking

Intervention

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
• Test message
Participants will read test message

Locations

Country	Name	City	State
United States	University of Minnesota, Tobacco Research Program, 717 Delaware St., SE	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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