Remote Trial - Tobacco Product Standard (VLNC)

Fully Remote Randomized Controlled Trial Exploring the Role of Non-combustible Tobacco Products in the Context of a Nicotine Product Standard for Cigarettes

The goal of this pilot project is to explore the feasibility of a real-world marketplace study design examining the effects of a reduced nicotine product standard for cigarettes on smoking in the context of a flavor restriction vs. no restriction on e-cigarettes in smokers switched to very low nicotine content cigarettes.

Study Overview

• Status: Terminated
• Conditions: Tobacco Use
• Intervention / Treatment: Other: Tobacco and non-tobacco e-cigarettes; Other: Tobacco only e-cigarettes

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Self-report of daily smoking of at least 5 to 25 cigarettes for >3 months by self-report.
• Carbon monoxide indicative of regular smoking (CO > 6ppm) prior to randomization.
• Has regular access to a smartphone, tablet or computer with functioning camera and internet access for telehealth visits and surveys and to take photos of receipts.
• Lives in an area where VLN® cigarettes are being marketed (these locations may vary during the course of the study).

Exclusion Criteria:

• Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, liver or kidney disease, COPD, bronchitis, within the past 3 months, seizure disorder and cancer (cancer-free <5 years except some skin cancers can be within 5 years), or a COVID-19 positive test or COVID-19 symptoms in the last 14 days or as determined by the licensed medical professional at each site).
• Unstable mental health (to be determined by medical history, Patient Health Questionnaire-2 (Prime-MD) and GAD-2 after review by the licensed medical professional).
• Excessive drinking or problems with drinking or drugs-including marijuana (assessed by PI or licensed medical professional).
• Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy.
• Taking exclusionary medications, unstable dosing of medications, or unstable control of symptoms for ongoing medical conditions (medications or conditions that would impact patient safety to be determined by the licensed medical professional).
• Recent experience with VLNC cigarettes (purchasing of the VLNC cigarettes in the past year)
• Household member enrolled in the study concurrently.
• Participated in prior research study during the past three months that would impact baseline smoking or response to study products.
• Inability to independently read and comprehend the consent form and follow other written study instructions, materials or measures or behavior indicating inability to fully participate in study procedures. Participants are required to complete the protocol at home independently and must show ability to comply with directions.
• Unstable living environment that would compromise the ability to sequester study products or complete study procedures.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VLNC cigarettes plus access to tobacco and non-tobacco flavored e-cigarettes; Smokers who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Participants will then be randomly assigned to a 4-week intervention	Other: Tobacco and non-tobacco e-cigarettes; Participants with no e-cigarette restrictions.
Experimental: VLNC cigarettes plus access to only tobacco flavored e-cigarettes; Smokers who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Participants will then be randomly assigned to a 4-week intervention	Other: Tobacco only e-cigarettes; Participants restricted to tobacco flavored e-cigarettes only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of participants that drop-out by 4 week visit	Percent of participants that drop-out by 4 week visit	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean cigarettes per day (CPD)	Change in mean cigarettes per day (CPD) based on 7 day ITR data before visit 00 and week 4 visits	Baseline to 4 weeks
Number of participants experiencing smoke free days		4 weeks

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Actual): April 7, 2025
• Study Completion (Actual): April 7, 2025

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: reducing nicotine cigarettes
• Other Study ID Numbers: 2023LS188

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No