Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors

Not Applicable

Completed

• Conditions: Tobacco Addiction; Dual Tobacco Use
• Interventions: Other: Combusted Products; Other: VLNC cigarettes; Other: Non-combusted products; Other: CN cigarettes

• Registration Number: NCT02000921
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-11-27
• Study First Submitted QC: 2013-11-27
• Study Start: 2013-12
• Study First Posted: 2013-12-04
• Primary Completion: 2015-09
• Study Completion: 2016-09
• Results First Submitted: 2016-11-30
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-14
• Last Update Submitted: 2017-02-14
• Results First Posted: 2017-03-31
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CN + combusted & non-combusted products	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.
VLNC with non-combusted products	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.
VLNC + combusted & non-combusted products	VLNC cigarettes	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.
VLNC with non-combusted products	VLNC cigarettes	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.
CN + combusted & non-combusted products	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.
CN + combusted & non-combusted products	CN cigarettes	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.
VLNC + combusted & non-combusted products	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.
VLNC + combusted & non-combusted products	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.

Primary Outcome Measures

Name	Time	Method
Number of Days Using Alternative Products	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.
Number of Combusted Products Smoked	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

Name	Time	Method
Rate of 24 Hour Quit Attempts	8 week intervention period	Rate of 24 hour quit attempts during the intervention period
Carcinogen Exposure Biomarker: Total NNAL	Week 8 (end of intervention)	Total NNAL (pmol/mg creatinine) is a measure of carcinogen exposure assessed at the end of intervention.

Trial Locations

Locations (1)

University of Minnesota Tobacco Research Program; 🇺🇸 Minneapolis, Minnesota, United States