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Trial record 1 of 1 for:    NCT02000921
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Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors

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ClinicalTrials.gov Identifier: NCT02000921
Recruitment Status : Completed
First Posted : December 4, 2013
Results First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tobacco Addiction Dual Tobacco Use Other: VLNC cigarettes Other: Combusted Products Other: Non-combusted products Other: CN cigarettes Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Models for Tobacco Productive Evaluation: Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors
Study Start Date : December 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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: VLNC cigarettes
Modified risk tobacco product
Other Name: Very Low Nicotine Content Cigarettes

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.

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: VLNC cigarettes
Modified risk tobacco product
Other Name: Very Low Nicotine Content Cigarettes

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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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:

  • 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.

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): NCT02000921


Locations
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United States, Minnesota
University of Minnesota Tobacco Research Program
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Dorothy K Hatsukami, PhD University of Minnesota
Publications:
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02000921    
Other Study ID Numbers: 2013NTLS012
U19CA157345 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2013    Key Record Dates
Results First Posted: March 31, 2017
Last Update Posted: March 31, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Minnesota:
Cigarette Smoking
Very Low Nicotine Content cigarettes (VLNC)
Dual Tobacco Use
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
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