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Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace

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ClinicalTrials.gov Identifier: NCT03272685
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : October 23, 2018
Sponsor:
Collaborators:
Duke University
University of California, San Francisco
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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
Tobacco Smoking Nicotine Dependence 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=350 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 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.
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 : June 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Conventional Nicotine Content Cigarettes




Primary Outcome Measures :
  1. Cigarettes Per Day (CPD) [ Time Frame: 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. Cigarette-free Days [ Time Frame: 12 weeks on study cigarettes ]
    Rate of cigarette-free days, defined as no cigarettes smoked in the past 24 hours calculated as the proportion of cigarette-free days out of the total number of days in Phase 3.


Secondary Outcome Measures :
  1. Percent Change in Total Nicotine Equivalents (TNE) [ Time Frame: 12 weeks (Phase 3) on study cigarettes ]
    Percent change in TNE, measure of nicotine and it's metabolites, from the end of Phase 2 (experimental marketplace with usual brand cigarettes) to end of Phase 3 (experimental marketplace with study cigarettes).

  2. Percent Change in 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) [ Time Frame: 12 weeks (Phase 3) on study cigarettes ]
    Change in total NNAL pmol/mg creatinine, (a measure of the exposure to NNK, a tobacco specific nitrosamine) from the end of Phase 2 (experimental marketplace with usual brand cigarettes) to end of Phase 3 (experimental marketplace with study cigarettes).

  3. Percent Change in 2-cyanoethyl-mercapturic Acid (CEMA) [ Time Frame: 12 weeks (Phase 3) on study cigarettes ]
    Change in CEMA (biomarker for the mercapturic acid acrolonitrile) from end of Phase 2 (experimental marketplace with usual brand cigarettes) to end of Phase 3 (experimental marketplace with study cigarettes).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female;
  2. At least 18 years at University of MN or Duke University or 21 years of age at University of California, San Francisco;
  3. Biochemically confirmed smoker.

Exclusion Criteria:

  1. Unstable health condition;
  2. Unstable medications;
  3. Positive drug screen (except for marijuana);
  4. Pregnant or nursing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272685


Contacts
Contact: Lori Strayer, MS 612-626-5189 strayer@umn.edu
Contact: Joni Jensen, MPH 612-624-5178 jense010@umn.edu

Locations
United States, California
Tobacco Research Center Recruiting
San Francisco, California, United States, 94110
Contact: Natalie Program Manager, PhD    415-514-1450    Natalie.Nardone@ucsf.edu   
Contact: Jennifer Coordinator    514    KoJ@medsfgh.ucsf.edu   
Principal Investigator: Neal Benowitz, MD         
United States, Minnesota
Tobacco Research Programs Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Joni Jensen, MPH    612-624-5178    jense010@umn.edu   
Contact: Laura Coordinator    612-623422    byexx099@umn.edu   
Principal Investigator: Dorothy Hatsukami, PhD         
United States, North Carolina
Tobacco Recruiting
Durham, North Carolina, United States, 27705
Contact: Rachel Program Manager    919-668-2963    Rachel.kozink@duke.edu   
Contact: Alicia Coordinator       Alicia.holloway@duke.edu   
Principal Investigator: F J McClernon, PhD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Duke University
University of California, San Francisco
Investigators
Principal Investigator: Dorothy Hatsukami, PHD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03272685     History of Changes
Other Study ID Numbers: 2017NTLS107
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Time Frame: Data will not be available until primary and secondary papers are accepted for publication.
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.

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 - Clinical and Translational Science Institute:
Reduced nicotine cigarettes
Alternative nicotine products
Biomarkers of tobacco exposure

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action