Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace

Sponsor
University of Minnesota (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03272685
Collaborator
Duke University (Other), University of California, San Francisco (Other), Wake Forest University (Other), University of Pennsylvania (Other), Brown University (Other)
440
6
2
56.9
73.3
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Very Low Nicotine Content Cigarettes
  • Drug: Normal Nicotine Content Cigarettes
Phase 3

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/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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
440 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Phase III randomized, open label, multi-center study that will examine the impact of very low nicotine content (VLNC) cigarettes using an experimental marketplace that contains tobacco and nicotine products, simulating a real world environment. There are three phases: Phase 1 is smoking usual brand cigarettes. Phase 2 is access to a marketplace with usual brand cigarettes and other non-combusted nicotine and tobacco products. Phase 3 involves access to a marketplace with study cigarettes and other non-combusted nicotine and tobacco products.Phase III randomized, open label, multi-center study that will examine the impact of very low nicotine content (VLNC) cigarettes using an experimental marketplace that contains tobacco and nicotine products, simulating a real world environment. There are three phases: Phase 1 is smoking usual brand cigarettes. Phase 2 is access to a marketplace with usual brand cigarettes and other non-combusted nicotine and tobacco products. Phase 3 involves access to a marketplace with study cigarettes and other non-combusted nicotine and tobacco products.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace Part of "Evaluating New Nicotine Standards for Cigarettes"
Actual Study Start Date :
Jun 1, 2018
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Very Low Nicotine Content Cigarettes

Very low nicotine content cigarettes (0.4 mg/g nicotine; 9 mg of tar)

Drug: Very Low Nicotine Content Cigarettes
0.4 mg/g nicotine; 9 mg tar
Other Names:
  • Reduced Nicotine Content Cigarettes
  • Active Comparator: Normal Nicotine Content Cigarettes

    Normal (Conventional) Nicotine Content (15.8 mg/g nicotine; 9 mg of tar)

    Drug: Normal Nicotine Content Cigarettes
    15.8 mg/g nicotine; 9 mg tar
    Other Names:
  • Conventional Nicotine Content Cigarettes
  • Outcome Measures

    Primary Outcome Measures

    1. Cigarettes Per Day (CPD) [7 days prior to end of Phase 2 and the end of Week 12 (12 weeks on study cigarettes)]

      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).

    2. Smoke-free Days [12 weeks on study cigarettes]

      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.

    Secondary Outcome Measures

    1. Percent Change in 2-cyanoethyl-mercapturic Acid (CEMA) [12 weeks (Phase 3) on study cigarettes]

      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).

    2. 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).

    3. Seven-day Abstinence from Cigarettes [7 days]

      Total cigarettes per day equal to 0 for all 7 days before the week 12 visit and carbon monoxide (CO) ≤ 6ppm at week 12.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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;

    1. Pregnant or nursing.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tobacco Research Center San Francisco California United States 94110
    2 Tobacco Research Programs Minneapolis Minnesota United States 55414
    3 Tobacco Durham North Carolina United States 27705
    4 Wake Forest Tobacco Control Center of Excellence Winston-Salem North Carolina United States 27175
    5 Center for Interdisciplinary Research on Nicotine Addiction Philadelphia Pennsylvania United States 19104
    6 Brown University Center for Alcohol and Addiction Studies School of Public Health Providence Rhode Island United States 02912

    Sponsors and Collaborators

    • University of Minnesota
    • Duke University
    • University of California, San Francisco
    • Wake Forest University
    • University of Pennsylvania
    • Brown University

    Investigators

    • Principal Investigator: Dorothy Hatsukami, PHD, University of Minnesota

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT03272685
    Other Study ID Numbers:
    • 2017NTLS107
    First Posted:
    Sep 5, 2017
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by University of Minnesota
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 21, 2022