Feasibility Study - Filter Ventilation

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Tobacco Use
• Intervention / Treatment: Other: Unventilated filter cigarettes; Other: Ventilated filter cigarettes

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55405
      • University of Minnesota
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unventilated Filter Cigarette; Conventional cigarette with approximately 6-7% (non-menthol) and 5-6% filter ventilation (menthol).	Other: Unventilated filter cigarettes; Currently marketed unventilated cigarettes
Active Comparator: Ventilated Filter Cigarette; Conventional cigarette with approximately 22-26% (non-menthol) and 35-38% filter ventilation (menthol).	Other: Ventilated filter cigarettes; Currently marketed ventilated cigarettes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of approach - Drop outs	Percent of drop-outs in baseline and post-randomization.	Baseline through Week 6
Feasibility of approach - Missing Data	Extent (percent) of missing data	Baseline through Week 6
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborators: Ohio State University
• Investigators: Principal Investigator: Dorothy Hatsukami, PH.D, Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020LS110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No