N/A N=115 Randomized Prevention

Effects of Filter Ventilation and Ventilation Information on Product Use Behaviors in Cigarette Smokers

Cigarette Smoking-Related Carcinoma

Bottom Line

View on ClinicalTrials.gov: NCT04744285 ↗

Enrolled (actual)

115

Serious AEs

0.0%

Results posted

Dec 2023

Primary outcome: Primary: Subjective Questionnaires of Product Evaluation — 4.27; 3.86; 4.16; 4.9 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cigarette packaging (Other); Data capture (Other); Questionnaire administration (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Roswell Park Cancer Institute
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Subjective Questionnaires of Product Evaluation	4.27; 3.86; 4.16; 4.9; 4.27; 3.82	—
PRIMARY Readiness to Quit	6.27; 5.79; 6.58; 6.24	—
PRIMARY Withdrawal	13.2; 12.3; 8.8; 13.9	—
SECONDARY Level of Exhaled Carbon Monoxide (CO)	21.3; 15.0; 22.6; 27.6	—

Summary

This clinical trial collects data to see how filter ventilation and ventilation information affects product use behaviors in cigarette smokers. Providing ventilation information on the cigarette package may affect smokers' rating of product appeal, perceptions of health risk, and changes in cigarette consumption.

Eligibility Criteria

Inclusion Criteria

Aged 21-69 years old
Currently smoking daily, at least 5 cigarettes per day, for the past year:
Primarily using factory-made filtered cigarettes
Fair and above self-rated physical health (self-rated)
Fair and above self-rated mental health (self-rated)
Not planning to quit smoking in the next 30 days
Able to converse, read, and write in English
Access to smartphone (e.g., iPhone, Android) for Ecological Momentary Assessment (EMA) component
Access to a smartphone/tablet/computer with video capabilities and internet access for remote videoconferencing (EMA check-ins)
Alcohol Use Disorders Identification Test (AUDIT)-C 69
Using roll-your-own cigarettes or usual brand of cigarettes is unfiltered
Planning to quit smoking in the next 30 days
Adults unable to consent
Minors (any persons under age 21)
Prisoners
Poor physical health by self-report
Poor mental health by self-report:
Exclude Dx psychosis, Dx bipolar, K6 score indicating serious psychological distress
AUDIT-C score >=7 (i.e. problematic alcohol consumption)
Cannabis use >5 days in past month
Other illegal drug use in past month
Pregnant or breastfeeding by self-report
No access to smartphone or videoconferencing

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04744285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.