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Completed

NCT Number: NCT02000921

Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors

The main focus of this study is to determine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted and/or non-combusted tobacco, or cessation of all tobacco containing products.

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Key information

Conditions

Tobacco Addiction Behavior Cigarette Smoking Dual Tobacco Use Smoking Tobacco Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota Tobacco Research Program

Minneapolis, Minnesota, 55414, United States

About this study

This is a single site, single-blind, randomized trial with three experimental conditions tested for a period of 8 weeks: 1) Very low nicotine content (VLNC) cigarettes (0.07 nicotine yield) with access to combusted (except cigarettes) and non-combusted tobacco and medicinal nicotine products; 2) VLNC cigarettes with access to only non-combusted tobacco and medicinal nicotine products; and 3) conventional nicotine (CN) content experimental cigarettes (0.8 mg nicotine) with access to combusted and non-combusted products. This study will examine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted (e.g., little cigars, large cigars, pipes) and/or non-combusted tobacco products (e.g., conventional smokeless tobacco, snus for smokers, dissolvables, e-cigarettes, medicinal nicotine), or cessation of all tobacco containing products. Toxicant exposure across the three conditions will also be examined.

Eligible subjects will be provided very low nicotine content cigarettes and are told to use the product ad lib for 8 weeks. Subjects will complete questionnaires on demographics, smoking and health history, drug and alcohol use history, mood and perceptions of the study tobacco product. Biomarker samples will be analyzed for exposure levels of nicotine and tobacco-related toxicants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects who are at least 18 years of age with a history of regular smoking for at least 1 year and no serious quit attempts in the last 3 months
  • No unstable and significant medical or psychiatric conditions, including lack of stabilization of medications.
  • Subject has provided written informed consent to participate in the study

Exclusion criteria

  • Regular use of tobacco products (including e-cigarettes) other than cigarettes
  • Regular use of nicotine replacement or other tobacco cessation products for purpose of quitting.
  • Pregnant or breastfeeding (due to toxic effects from tobacco products).
  • Planned quit date within the next two months.
  • Does not have a way that the research team can communicate with them by phone or e-mail.
  • Not able to read and write English well enough to complete study activities without translation.

Treatment and study plan

VLNC cigarettes

Other

Modified risk tobacco product

Other names: Very Low Nicotine Content Cigarettes

Combusted Products

Other

Options for combusted tobacco products include cigars, cigarillos, and little cigars, .

Non-combusted products

Other

Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.

CN cigarettes

Other

Experimental cigarettes with conventional nicotine content.

Primary outcomes

  1. Number of Days Using Alternative Products

    Time frame: 8 week intervetnion period

    The primary aim of the study is to determine the rate of use of alternative nicotine-containing products across the three experimental conditions.

  2. Number of Combusted Products Smoked

    Time frame: At weeks 6-8 (last two weeks of intervention period)

    Number of combusted products smoked per day during the last two weeks of the intervention period.

Secondary outcomes

  1. Rate of 24 Hour Quit Attempts

    Time frame: 8 week intervention period

    Rate of 24 hour quit attempts during the intervention period

  2. Carcinogen Exposure Biomarker: Total NNAL

    Time frame: Week 8 (end of intervention)

    Total NNAL (pmol/mg creatinine) is a measure of carcinogen exposure assessed at the end of intervention.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Models for Tobacco Productive Evaluation: Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Dec 4, 2013
Registry last updated
Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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