Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace

Phase 3

Completed

• Conditions: Nicotine Dependence; Tobacco Smoking
• Interventions: Drug: Very Low Nicotine Content Cigarettes; Drug: Normal Nicotine Content Cigarettes

• Registration Number: NCT03272685
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed 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 nicotine/g tobacco) along with non-combusted tobacco/nicotine products or 2) normal nicotine content cigarettes (NNC; 15.8 mg nicotine/g tobacco) 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).

Study Timeline

• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-09-01
• Study First Posted: 2017-09-05
• Study Start: 2018-06-01
• Primary Completion: 2022-09-30
• Study Completion: 2023-01-10
• Results First Submitted: 2023-10-23
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-24
• Last Update Submitted: 2024-07-24
• Results First Posted: 2024-08-20
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 799

Inclusion Criteria

1. Male or female;
2. 18/21 (legal age to purchase tobacco at site);
3. Biochemically confirmed smoker.

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Exclusion Criteria

1. Unstable health condition;
2. Unstable medications;
3. Pregnant or nursing.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Very Low Nicotine Content Cigarettes	Very Low Nicotine Content Cigarettes	Very Low Nicotine Content Cigarettes (0.4 mg nicotine/g tobacco; 9 mg of tar): Median nicotine content, averaged across menthol and non-menthol cigarettes:
Normal Nicotine Content Cigarettes	Normal Nicotine Content Cigarettes	Normal (Conventional) Nicotine Content (15.8 mg nicotine/g tobacco; 9 mg of tar): Median nicotine content, averaged across menthol and non-menthol cigarettes

Primary Outcome Measures

Name	Time	Method
Cigarettes Per Day (CPD)	7 days prior to week 12 visit	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).
Number of Smoke-free Days	day 1 of study until day before week 12 visit	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.; Number of smoke free days based on the interactive voice response (IVR)

Secondary Outcome Measures

Name	Time	Method
Seven Day Point-prevalence CO-verified Abstinence	7 days before week 12 visit	Total cigarettes per day equal to 0 for all 7 days before the week 12 visit and carbon monoxide (CO) ≤ 6ppm at week 12.
Percent Change in 2-cyanoethyl-mercapturic Acid (CEMA)	The last visit in Phase 2 is the end of the baseline	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).
Study Cigarettes Per Day	12 weeks (Phase 3) on study cigarettes	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).

Trial Locations

Locations (6)

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

Tobacco Research Programs; 🇺🇸 Minneapolis, Minnesota, United States

The Center for Addiction Science and Technology; 🇺🇸 Durham, North Carolina, United States

Center for Interdisciplinary Research on Nicotine Addiction; 🇺🇸 Philadelphia, Pennsylvania, United States

Wake Forest Tobacco Control Center of Excellence; 🇺🇸 Winston-Salem, North Carolina, United States