Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors

February 14, 2017 updated by: University of Minnesota

Models for Tobacco Productive Evaluation: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota Tobacco Research Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CN + combusted & non-combusted products
Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Other: Combusted Products
Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Other: Non-combusted products
Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
Other: CN cigarettes
Experimental cigarettes with conventional nicotine content.
EXPERIMENTAL: VLNC + combusted & non-combusted products
Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Other: Combusted Products
Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Other: Non-combusted products
Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
Other: VLNC cigarettes
Modified risk tobacco product
Other Names:
  • Very Low Nicotine Content Cigarettes
EXPERIMENTAL: VLNC with non-combusted products
Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
Other: Non-combusted products
Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
Other: VLNC cigarettes
Modified risk tobacco product
Other Names:
  • Very Low Nicotine Content Cigarettes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 week intervetnion period
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.
At weeks 6-8 (last two weeks of intervention period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of 24 Hour Quit Attempts
Time Frame: 8 week intervention period
Rate of 24 hour quit attempts during the intervention period
8 week intervention period
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.
Week 8 (end of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Dorothy K Hatsukami, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (ESTIMATE)

December 4, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013NTLS012
  • U19CA157345 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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