Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace

Nicotine Dependence Clinical Trial

Official title:

Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace Part of "Evaluating New Nicotine Standards for Cigarettes"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272685
• Other study ID #: 2017NTLS107
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2018
• Est. completion date: January 10, 2023

Study information

• Verified date: January 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project will examine the impact of very low nicotine content (VLNC) cigarettes in a complex tobacco and nicotine product marketplace. We will compare the number of cigarettes smoked and cigarette-free days in an experimental marketplace that contains VLNC cigarettes versus normal nicotine content (NNC) cigarettes.

Description:

This randomized, open label, controlled, multi-site study will simulate a "real world" tobacco environment by providing participants access to an experimental marketplace where they will be given vouchers for a specified number of points that can be exchanged for study cigarettes (varying in nicotine content described below) and non-combusted tobacco/nicotine products (smokeless tobacco, snus, electronic cigarette, medicinal nicotine replacement) and at the end of the study can exchange unspent points for money. Subjects (N=200 in each group) will be randomly assigned to: 1) very low nicotine content cigarettes (VLNC; 0.4 mg/g) along with non-combusted tobacco/nicotine products or 2) normal nicotine content cigarettes (NNC; 15.8 mg/g) along with non-combusted tobacco/nicotine products. Smokers will undergo an orientation visit for screening and then enter a three phase experimental trial: 1. Phase 1 - Baseline: Two week baseline assessment period during usual brand cigarette smoking. 2. Phase 2 - Marketplace Adaptation: Two week period where subjects have access to the marketplace that provides their preferred usual brand cigarettes and selected non-combusted tobacco products to allow the subject to adjust to the marketplace prior to randomization; 3. Phase 3 - Intervention: Randomization to a marketplace with access to either VLNC or NNC cigarettes plus non-combusted products for a 12 week period. Biomarker samples are collected at baseline, end of Phase 2 and end of week Phase 3 (week 12).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 799
• Est. completion date: January 10, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Male or female;

2. At least 21 years of age;

3. Biochemically confirmed smoker.

Exclusion Criteria:

1. Unstable health condition;

2. Unstable medications; d) Pregnant or nursing.

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Smoking
• Tobacco Use Disorder

Intervention

Drug:
• Very Low Nicotine Content Cigarettes
0.4 mg/g nicotine; 9 mg tar
• Normal Nicotine Content Cigarettes
15.8 mg/g nicotine; 9 mg tar

Locations

Country	Name	City	State
United States	The Center for Addiction Science and Technology	Durham	North Carolina
United States	Tobacco Research Programs	Minneapolis	Minnesota
United States	Center for Interdisciplinary Research on Nicotine Addiction	Philadelphia	Pennsylvania
United States	Brown University Center for Alcohol and Addiction Studies School of Public Health	Providence	Rhode Island
United States	Tobacco Research Center	San Francisco	California
United States	Wake Forest Tobacco Control Center of Excellence	Winston-Salem	North Carolina

Sponsors (6)

Lead Sponsor	Collaborator
University of Minnesota	Brown University, Duke University, University of California, San Francisco, University of Pennsylvania, Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarettes Per Day (CPD)	The mean cigarettes (study and non-study cigarettes) smoked per day based on 7 days Daily Interactive Voice Response (IVR) data at the end of Phase 3 (experimental marketplace with study cigarettes) compared to Phase 2 (experimental marketplace with usual brand cigarettes).	7 days prior to end of Phase 2 and the end of Week 12 (12 weeks on study cigarettes)
Primary	Smoke-free Days	Rate of smoke-free days, defined as no cigarettes smoked in the past 24 hours calculated as the proportion of smoke-free days out of the total number of days in Phase 3.	12 weeks on study cigarettes
Secondary	Percent Change in 2-cyanoethyl-mercapturic Acid (CEMA)	Change in CEMA (biomarker for the mercapturic acid acrylonitrile) from end of Phase 2 (experimental marketplace with usual brand cigarettes) to end of Phase 3 (experimental marketplace with study cigarettes).	12 weeks (Phase 3) on study cigarettes
Secondary	Study Cigarettes Per Day	The mean study cigarettes smoked per day based on 7 days Daily Interactive Voice Response (IVR) data at the end of Phase 3 (experimental marketplace with study cigarettes) compared to Phase 2 (experimental marketplace with usual brand cigarettes).	12 weeks (Phase 3) on study cigarettes
Secondary	Seven-day Abstinence from Cigarettes	Total cigarettes per day equal to 0 for all 7 days before the week 12 visit and carbon monoxide (CO) = 6ppm at week 12.	7 days