Remote Trial - Tobacco Product Standard (VLNC)

NCT06442384 | Terminated DMC

• 1 other identifier: 2023LS188
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco Use

Keywords

reducing nicotine cigarettes

Outcome Measures

Primary Outcomes (1)

• Percent of participants that drop-out by 4 week visit

  Percent of participants that drop-out by 4 week visit

  4 weeks

Secondary Outcomes (2)

• Change in mean cigarettes per day (CPD)

  Baseline to 4 weeks

• Number of participants experiencing smoke free days

  4 weeks

Study Arms (2)

VLNC cigarettes plus access to tobacco and non-tobacco flavored e-cigarettes

EXPERIMENTAL

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

VLNC cigarettes plus access to only tobacco flavored e-cigarettes

EXPERIMENTAL

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

Interventions

Tobacco and non-tobacco e-cigarettes OTHER

Participants with no e-cigarette restrictions.

VLNC cigarettes plus access to tobacco and non-tobacco flavored e-cigarettes

Tobacco only e-cigarettes OTHER

Participants restricted to tobacco flavored e-cigarettes only.

VLNC cigarettes plus access to only tobacco flavored e-cigarettes

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tobacco Use

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: September 11, 2024
• Primary Completion: April 7, 2025
• Study Completion: April 7, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

US (1)