Clinical trial NCT04740008: Impact of Low Nicotine Cigarette Messaging on Perceptions and Cigarette Choices
Official title: Impact of Low Nicotine Cigarette Messaging on Risk Perceptions and Hypothetical Tobacco and Nicotine Product Choices.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Smoking
Cigarette
Keywords: Low Nicotine Content
Educational Messaging
Cigarette
Smoking
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Proportion of participants that choose ANDS or no tobacco
timeFrame: Within 17 days of virtual screening
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, Tobacco Research Program, 717 Delaware St., SE
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Dana Mowls Carroll, Ph.D., M.P.H
role: PRINCIPAL_INVESTIGATOR
References: