Novel Determinants and Measures of Smokeless Tobacco Use: Study 2
2 other identifiers
interventional
278
1 country
2
Brief Summary
The research project will determine the level of nicotine in ST products that will lead to the greatest reduction in toxicant exposure
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2010
CompletedFirst Posted
Study publicly available on registry
February 11, 2010
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFebruary 26, 2018
February 1, 2018
3.4 years
February 10, 2010
February 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1. To determine if switching to ST products with reduced toxicant levels will result in reduction of biomarkers of exposure and toxicity. 2. To determine the nicotine levels of ST that would lead to the greatest reduction in tobacco toxicant exposure.
8 weeks
Secondary Outcomes (1)
To determine the extent to which varying low nicotine ST products leads to compensatory tobacco use.
8 weeks
Study Arms (3)
Low nicotine
ACTIVE COMPARATORConventional smokeless tobacco product with 1) NNN plus NNK of \<2 μg/gram and nicotine levels of \>5 mg/g wet weight
Medium nicotine
ACTIVE COMPARATORConventional smokeless tobacco product with ) NNN plus NNK of \<2 μg/gram and nicotine levels of 3-5 mg/g wet weight.
High nicotine
ACTIVE COMPARATORConventional smokeless tobacco product with NNN plus NNK of \<2 μg/gram and nicotine levels of \<3 mg/g wet weight
Interventions
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
Eligibility Criteria
You may qualify if:
- Using a consistent and daily amount of ST with specific nicotine and tobacco-specific nitrosamine (TSNA) levels for the past year;
- In good physical health (no unstable medical condition);
- Stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).
You may not qualify if:
- Subjects must not be currently using other tobacco or nicotine products.
- Female subjects cannot be pregnant or nursing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- National Cancer Institute (NCI)collaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (2)
University of Minnesota
Minneapolis, Minnesota, 55414, United States
Oregon Research Institute
Eugene, Oregon, 97403, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dorothy Hatsukami, PhD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2010
First Posted
February 11, 2010
Study Start
March 1, 2012
Primary Completion
August 1, 2015
Study Completion
October 1, 2016
Last Updated
February 26, 2018
Record last verified: 2018-02