Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace

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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Smoking; Nicotine Dependence
• Intervention / Treatment: Drug: Very Low Nicotine Content Cigarettes; Drug: Normal Nicotine Content 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 Type: Interventional
• Enrollment (Actual): 799
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Tobacco Research Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Tobacco Research Programs
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • The Center for Addiction Science and Technology
    • Winston-Salem, North Carolina, United States, 27175
      • Wake Forest Tobacco Control Center of Excellence
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Center for Interdisciplinary Research on Nicotine Addiction
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University Center for Alcohol and Addiction Studies School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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:	Drug: Very Low Nicotine Content Cigarettes; 0.4 mg nicotine/g tobacco; 9 mg tar; Other Names: Reduced Nicotine Content Cigarettes
Active Comparator: 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	Drug: Normal Nicotine Content Cigarettes; 15.8 mg nicotine/g tobacco; 9 mg tar; Other Names: Conventional Nicotine Content Cigarettes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 week 12 visit
Number of 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. Number of smoke free days based on the interactive voice response (IVR)	day 1 of study until day before week 12 visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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).	The last visit in Phase 2 is the end of the baseline
Seven Day Point-prevalence CO-verified Abstinence	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 before week 12 visit

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: University of Pennsylvania; Brown University; Duke University; University of California, San Francisco; Wake Forest University
• Investigators: Principal Investigator: Dorothy Hatsukami, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 5, 2017

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Reduced nicotine cigarettes; Alternative nicotine products; Biomarkers of tobacco exposure
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2017NTLS107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Intend to share findings from this research through publications and presentations. Institutions and individuals wishing to access any resources or data must contact the Principal Investigator (Hatsukami). Data will be available in two formats. One will be a summary of the data, with graphs and tables, posted as pdf files and as raw individual-level data for analysis. Data generated by this grant will be made to outside investigators, according to NIH Guidance. When data are shared, there will be no limits placed on how the data will be used. Users will agree, however, that the recipient must not transfer the data to other users and that the data are only to be used for research purposes. A record of transfer of data and a copy of the dataset that was distributed will be kept by University of Minnesota.
• IPD Sharing Time Frame: Data will not be available until primary and secondary papers are accepted for publication.
• IPD Sharing Access Criteria: Persons requesting data must do so in writing, identifying their affiliation and how the data will be used. Upon review, access will be determined.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No