Novel Determinants and Measures of Smokeless Tobacco Use: Study 2

ID: NCT01067599
Status: Completed
Phase: N/A
Start Date: March 01, 2012
First Submitted: February 10, 2010
Last Updated: February 22, 2018
Results: N/A
Sponsors & Collaborators: University of Minnesota - Clinical and Translational Science Institute, National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)
Location: United States
Conditions: Tobacco Use Disorder, Nicotine Dependence
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Study Description

Brief Summary

The research project will determine the level of nicotine in ST products that will lead to the greatest reduction in toxicant exposure

Detailed Description

This is a randomized, multi-site trial determining the effects of switching smokeless tobacco (ST) users to lower toxicant ST products which vary in nicotine levels on biomarkers of exposure and patterns of use. ST users will undergo a two week baseline assessment period and then randomly assigned to one of three oral tobacco products (lower NNK plus NNN product with three different levels of nicotine) for a period of 8-weeks. Follow-up will occur at 9 and 20 weeks.
Condition or disease Intervention/treatment Phase

Nicotine Dependence

Tobacco Use Disorder

Other: Low nicotine
Other Names
Other: Medium nicotine
Other Names
Other: High nicotine
Other Names
N/A

Tracking Information

First Submitted DateFebruary 10, 2010
Last Update Posted DateFebruary 22, 2018
Actual Start DateMarch 01, 2012
Actual Completion DateOctober 01, 2016
Actual Primary Completion DateAugust 01, 2015
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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. [Time Frame: 8 weeks]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • To determine the extent to which varying low nicotine ST products leads to compensatory tobacco use. [Time Frame: 8 weeks]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleNovel Determinants and Measures of Smokeless Tobacco Use: Study 2
Official TitleNovel Determinants and Measures of Smokeless Tobacco Use: Study 2 Effects of Switching Levels of Nicotine and TSNA in Products on Smokeless Tobacco Use
Brief Summary

The research project will determine the level of nicotine in ST products that will lead to the greatest reduction in toxicant exposure

Detailed Description

This is a randomized, multi-site trial determining the effects of switching smokeless tobacco (ST) users to lower toxicant ST products which vary in nicotine levels on biomarkers of exposure and patterns of use. ST users will undergo a two week baseline assessment period and then randomly assigned to one of three oral tobacco products (lower NNK plus NNN product with three different levels of nicotine) for a period of 8-weeks. Follow-up will occur at 9 and 20 weeks.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
278
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
Primary Purpose
Treatment
Conditions
Nicotine Dependence
Tobacco Use Disorder
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Other: Low nicotine

Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.

Other Names
Other: Medium nicotine

Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.

Other Names
Other: High nicotine

Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.

Other Names
Study Groups/Cohorts
Low nicotine
Conventional smokeless tobacco product with 1) NNN plus NNK of <2 μg/gram and nicotine levels of >5 mg/g wet weight

Medium nicotine
Conventional smokeless tobacco product with ) NNN plus NNK of <2 μg/gram and nicotine levels of 3-5 mg/g wet weight.

High nicotine
Conventional smokeless tobacco product with NNN plus NNK of <2 μg/gram and nicotine levels of <3 mg/g wet weight

Study Arms
Active Comparator High nicotine
Conventional smokeless tobacco product with NNN plus NNK of <2 μg/gram and nicotine levels of <3 mg/g wet weight
Other : High nicotine
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.

Active Comparator Low nicotine
Conventional smokeless tobacco product with 1) NNN plus NNK of <2 μg/gram and nicotine levels of >5 mg/g wet weight
Other : Low nicotine
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.

Active Comparator Medium nicotine
Conventional smokeless tobacco product with ) NNN plus NNK of <2 μg/gram and nicotine levels of 3-5 mg/g wet weight.
Other : Medium nicotine
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.

Arm Intervention/Treatment
Active Comparator High nicotine
Conventional smokeless tobacco product with NNN plus NNK of <2 μg/gram and nicotine levels of <3 mg/g wet weight
Other : High nicotine
Active Comparator Low nicotine
Conventional smokeless tobacco product with 1) NNN plus NNK of <2 μg/gram and nicotine levels of >5 mg/g wet weight
Other : Low nicotine
Active Comparator Medium nicotine
Conventional smokeless tobacco product with ) NNN plus NNK of <2 μg/gram and nicotine levels of 3-5 mg/g wet weight.
Other : Medium nicotine

Recruitment Information

Recruitment Status:Completed
Enrollment278
Completion DateOctober 01, 2016
Eligibility Criteria: Inclusion Criteria:
1. Using a consistent and daily amount of ST with specific nicotine and tobacco-specific nitrosamine (TSNA) levels for the past year;
2. In good physical health (no unstable medical condition);
3. Stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).

Exclusion Criteria:
1. Subjects must not be currently using other tobacco or nicotine products.
2. Female subjects cannot be pregnant or nursing.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT01067599
Other Study ID Numbers
1R01CA141531-01
1R01CA141531
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
University of Minnesota - Clinical and Translational Science Institute
Collaborators
National Cancer Institute (NCI)
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator
Dorothy Hatsukami, PhD
University of Minnesota - Clinical and Translational Science Institute