Clinical trial NCT02000921: Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors
Official title: Models for Tobacco Productive Evaluation: Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Addiction
Dual Tobacco Use
Keywords: Cigarette Smoking
Very Low Nicotine Content cigarettes (VLNC)
Dual Tobacco Use
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-12-04
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Number of Days Using Alternative Products
timeFrame: 8 week intervetnion period
measure: Number of Combusted Products Smoked
timeFrame: At weeks 6-8 (last two weeks of intervention period)
Secondary outcomes:
measure: Rate of 24 Hour Quit Attempts
timeFrame: 8 week intervention period
measure: Carcinogen Exposure Biomarker: Total NNAL
timeFrame: Week 8 (end of intervention)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Tobacco Research Program
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy K Hatsukami, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hatsukami DK, Luo X, Dick L, Kangkum M, Allen SS, Murphy SE, Hecht SS, Shields PG, al'Absi M. Reduced nicotine content cigarettes and use of alternative nicotine products: exploratory trial. Addiction. 2017 Jan;112(1):156-167. doi: 10.1111/add.13603. Epub 2016 Nov 2.