Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors
Models for Tobacco Productive Evaluation: Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors
2 other identifiers
interventional
136
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedFirst Posted
Study publicly available on registry
December 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
March 31, 2017
CompletedMarch 31, 2017
February 1, 2017
1.8 years
November 27, 2013
November 30, 2016
February 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
At weeks 6-8 (last two weeks of intervention period)
Secondary Outcomes (2)
Rate of 24 Hour Quit Attempts
8 week intervention period
Carcinogen Exposure Biomarker: Total NNAL
Week 8 (end of intervention)
Study Arms (3)
CN + combusted & non-combusted products
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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.
Interventions
Modified risk tobacco product
Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
Experimental cigarettes with conventional nicotine content.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Minnesota Tobacco Research Program
Minneapolis, Minnesota, 55414, United States
Related Publications (1)
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.
PMID: 27614097BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Exploratory study due to small number of participants. Only used first generation of electronic cigarette products.
Results Point of Contact
- Title
- Dorothy Hatsukami
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Dorothy K Hatsukami, PhD
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2013
First Posted
December 4, 2013
Study Start
December 1, 2013
Primary Completion
September 1, 2015
Study Completion
September 1, 2016
Last Updated
March 31, 2017
Results First Posted
March 31, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share