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Impact of Low Nicotine Cigarette Messaging on Perceptions and Cigarette Choices

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status and phase

Completed
Early Phase 1

Conditions

Smoking
Cigarette

Treatments

Other: Control message
Drug: Low Nicotine Content Cigarettes
Other: Test message

Study type

Interventional

Funder types

Other

Identifiers

NCT04740008
2020LS214 (Other Identifier)
SPH-2020-29384

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

64 participants in 2 patient groups

Control message on low nicotine cigarettes
Experimental group
Treatment:
Drug: Low Nicotine Content Cigarettes
Other: Control message
Test message on low nicotine cigarettes
Experimental group
Treatment:
Drug: Low Nicotine Content Cigarettes
Other: Test message

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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