Impact of Low Nicotine Cigarette Messaging on Perceptions and Cigarette Choices

Early Phase 1

Completed

• Conditions: Smoking; Cigarette
• Interventions: Drug: Low Nicotine Content Cigarettes; Other: Control message; Other: Test message

• Registration Number: NCT04740008
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Study Timeline

• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-05
• Study Start: 2021-04-20
• Primary Completion: 2022-08-24
• Study Completion: 2022-08-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control message on low nicotine cigarettes	Low Nicotine Content Cigarettes	-
Control message on low nicotine cigarettes	Control message	-
Test message on low nicotine cigarettes	Low Nicotine Content Cigarettes	-
Test message on low nicotine cigarettes	Test message	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants that choose ANDS or no tobacco	Within 17 days of virtual screening	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

Trial Locations

Locations (1)

University of Minnesota, Tobacco Research Program, 717 Delaware St., SE; 🇺🇸 Minneapolis, Minnesota, United States