Impact of Low Nicotine Cigarette Messaging on Perceptions and Cigarette Choices

NCT ID: NCT04740008

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2022-08-24

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.

Conditions

Smoking; Cigarette

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control message on low nicotine cigarettes

Group Type: EXPERIMENTAL

Low Nicotine Content Cigarettes

Intervention Type: DRUG

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

Control message

Intervention Type: OTHER

Participants will read control message

Test message on low nicotine cigarettes

Group Type: EXPERIMENTAL

Low Nicotine Content Cigarettes

Intervention Type: DRUG

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

Test message

Intervention Type: OTHER

Participants will read test message

Interventions

Low Nicotine Content Cigarettes

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

Intervention Type: DRUG

Control message

Participants will read control message

Intervention Type: OTHER

Test message

Participants will read test message

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana Mowls Carroll, Ph.D., M.P.H

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

University of Minnesota, Tobacco Research Program, 717 Delaware St., SE

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

2020LS214

Identifier Type: OTHER

Identifier Source: secondary_id

SPH-2020-29384

Identifier Type: -

Identifier Source: org_study_id