Impact of Low Nicotine Cigarette Messaging on Perceptions and Cigarette Choices

Sponsor

Masonic Cancer Center, University of Minnesota (Other)

Overall Status

Recruiting

CT.gov ID

NCT04740008

Collaborator

(none)

Enrollment

Location

Arms

26.3

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cigarette	Drug: Low Nicotine Content Cigarettes Other: Control message Other: Test message	Early Phase 1

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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 20, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Control message on low nicotine cigarettes	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
Experimental: Test message on low nicotine cigarettes	Drug: Low Nicotine Content Cigarettes Low Nicotine Content Cigarettes 0.4 mg/g nicotine; 9 mg tar Other Name: Reduced Nicotine Content Cigarettes Other: Test message Participants will read test message

Arm

Intervention/Treatment

Experimental: Control message on low nicotine cigarettes

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

Experimental: Test message on low nicotine cigarettes

Drug: Low Nicotine Content Cigarettes

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

Other: Test message

Participants will read test message

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota, Tobacco Research Program, 717 Delaware St., SE	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

Investigators

Principal Investigator: Dana Mowls Carroll, Ph.D., M.P.H, Masonic Cancer Center, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Masonic Cancer Center, University of Minnesota

ClinicalTrials.gov Identifier:

NCT04740008

Other Study ID Numbers:

SPH-2020-29384
2020LS214

First Posted:

Feb 5, 2021

Last Update Posted:

Jun 24, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Masonic Cancer Center, University of Minnesota

Low Nicotine Content

Educational Messaging

Cigarette

Smoking

Additional relevant MeSH terms:

Nicotine

Study Results

No Results Posted as of Jun 24, 2022