Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors

Tobacco Addiction Clinical Trial

Official title:

Models for Tobacco Productive Evaluation: Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02000921
• Other study ID #: 2013NTLS012
• Status: Completed
• Phase: N/A
• First received: November 27, 2013
• Last updated: October 20, 2015
• Start date: December 2013
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Dual Tobacco Use
• Tobacco Addiction

Intervention

Other:
• VLNC cigarettes
Modified risk tobacco product
• Combusted Products
Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
• Non-combusted products
Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
• CN cigarettes
Experimental cigarettes with conventional nicotine content.

Locations

Country	Name	City	State
United States	University of Minnesota Tobacco Research Program	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of nicotine product switching	The primary aim of the study is to determine the rate of use of nicotine-containing products across the three experimental conditions.	8 weeks	No