Remote Trial - Tobacco Product Standard (VLNC)

Tobacco Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06442384
• Other study ID #: 2023LS188
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: May 2024
• Source: Masonic Cancer Center, University of Minnesota
• Contact: Dorothy Hatsukami, PhD
• Phone: 612-626-2121
• Email: hatsu001[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Other:
• Tobacco and non-tobacco e-cigarettes
Participants with no e-cigarette restrictions.
• Tobacco only e-cigarettes
Participants restricted to tobacco flavored e-cigarettes only.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of participants that drop-out by 4 week visit	Percent of participants that drop-out by 4 week visit	4 weeks
Secondary	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
Secondary	Number of participants experiencing smoke free days		4 weeks