Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors

N/ACompletedNCT02000921

University of Minnesota136 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

136

Conditions

Tobacco Addiction Dual Tobacco Use

Interventions

VLNC cigarettesOTHER

Modified risk tobacco product

Combusted ProductsOTHER

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

Non-combusted productsOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Minnesota Tobacco Research Program

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Number of Days Using Alternative Products

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

Time frame: 8 week intervetnion period

Number of Combusted Products Smoked

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

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

Secondary Outcomes

Rate of 24 Hour Quit Attempts

Rate of 24 hour quit attempts during the intervention period

Time frame: 8 week intervention period

Carcinogen Exposure Biomarker: Total NNAL

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

Time frame: Week 8 (end of intervention)

Data from ClinicalTrials.gov

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