Feasibility Study - Filter Ventilation

Tobacco Use Clinical Trial

Official title:

Feasibility of Conducting a Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04514471
• Other study ID #: 2020LS110
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2021
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This open label, between-subject, randomized multi-center pilot study will assess the feasibility of conducting a study remotely with telehealth visits to assess the effect of cigarettes with minimal filter ventilation vs. moderate filter ventilation on smoking behavior and biomarkers of tobacco toxicant exposure. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes per a day will be collected remotely. Biological samples will be collected at home and mailed to the study clinic.

Description:

Smokers of cigarettes with about 16-30% ventilation in their conventional cigarettes who meet eligibility criteria will enter 3 weeks of monitoring of usual brand smoking. Subjects will then be randomly assigned for a period of 6 weeks to one of two conditions: 1) ventilated cigarettes; or 2) unventilated cigarettes. Subjects in each condition will be unblinded to simulate real world conditions. Subjects are provided with a debit card (ClinCard) that has been loaded with the appropriate amount of money to cover self-purchased usual brand cigarette in baseline and the assigned study cigarettes during intervention. Weekly telehealth visits will be conducted during baseline and the 6 weeks on study cigarettes to collect study measures, followed by a one month follow-up.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 21 years of age or older

• Regular cigarette smoker

• Currently smoking an eligible brand

• Generally good health

• Access to smartphone or tablet and a device with a functioning camera for telehealth visits. Also must have internet access.

Exclusion Criteria:

• Unstable health

• Uncontrolled high blood pressure

• Pregnant or breast-feeding

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Other:
• Unventilated filter cigarettes
Currently marketed unventilated cigarettes
• Ventilated filter cigarettes
Currently marketed ventilated cigarettes

Locations

Country	Name	City	State
United States	The Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota	Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of approach - Drop outs	Percent of drop-outs in baseline and post-randomization.	Baseline through Week 6
Primary	Feasibility of approach - Missing Data	Extent (percent) of missing data	Baseline through Week 6
Primary	Feasibility of approach - Participant Satisfaction	Degree of difficulty collecting data through telehealth visits, mailing in biosamples and self-purchase of cigarettes (descriptive statistics (e.g., percent or mean responses)	Baseline through Week 6
Secondary	Change in Total Nicotine Equivalents (TNE)	The sum of nicotine and its metabolite concentrations used for evaluating nicotine exposure.	effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference
Secondary	Change in 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)	One of the tobacco specific nitrosamines, one of the most important groups of carcinogens in tobacco products, which are formed from nicotine during the curing and processing of tobacco.	effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference
Secondary	Change in mean cigarettes per day (CPD)	The change in mean cigarettes per day (CPD) based on 7 day ITR data before visit 00 and week 6 visit.	effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference