Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors

University of Minnesota (UMN)

Status: Completed

Conditions: Dual Tobacco Use; Tobacco Addiction

Treatments: Other: CN cigarettes; Other: VLNC cigarettes; Other: Combusted Products; Other: Non-combusted products

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02000921

2013NTLS012

U19CA157345 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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136 participants in 3 patient groups

CN + combusted & non-combusted products

Experimental group

Description:

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.

Treatment:

Other: CN cigarettes

Other: Combusted Products

Other: Non-combusted products

VLNC + combusted & non-combusted products

Experimental group

Description:

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.

Treatment:

Other: VLNC cigarettes

Other: Combusted Products

Other: Non-combusted products

VLNC with non-combusted products

Experimental group

Description:

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.

Treatment:

Other: VLNC cigarettes

Other: Non-combusted products