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Novel Determinants and Measures of Smokeless Tobacco Use: Study 2

Primary Purpose

Tobacco Use Disorder, Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low nicotine
Medium nicotine
High nicotine
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Biomarkers of tobacco exposure, Smokeless Tobacco

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Minnesota
  • Oregon Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Low nicotine

Medium nicotine

High nicotine

Arm Description

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

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

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

Outcomes

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.

Secondary Outcome Measures

To determine the extent to which varying low nicotine ST products leads to compensatory tobacco use.

Full Information

First Posted
February 10, 2010
Last Updated
February 22, 2018
Sponsor
University of Minnesota
Collaborators
National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01067599
Brief Title
Novel Determinants and Measures of Smokeless Tobacco Use: Study 2
Official Title
Novel Determinants and Measures of Smokeless Tobacco Use: Study 2 Effects of Switching Levels of Nicotine and TSNA in Products on Smokeless Tobacco Use
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Nicotine Dependence
Keywords
Biomarkers of tobacco exposure, Smokeless Tobacco

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low nicotine
Arm Type
Active Comparator
Arm Description
Conventional smokeless tobacco product with 1) NNN plus NNK of <2 μg/gram and nicotine levels of >5 mg/g wet weight
Arm Title
Medium nicotine
Arm Type
Active Comparator
Arm Description
Conventional smokeless tobacco product with ) NNN plus NNK of <2 μg/gram and nicotine levels of 3-5 mg/g wet weight.
Arm Title
High nicotine
Arm Type
Active Comparator
Arm Description
Conventional smokeless tobacco product with NNN plus NNK of <2 μg/gram and nicotine levels of <3 mg/g wet weight
Intervention Type
Other
Intervention Name(s)
Low nicotine
Intervention Description
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
Intervention Type
Other
Intervention Name(s)
Medium nicotine
Intervention Description
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
Intervention Type
Other
Intervention Name(s)
High nicotine
Intervention Description
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To determine the extent to which varying low nicotine ST products leads to compensatory tobacco use.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: Subjects must not be currently using other tobacco or nicotine products. Female subjects cannot be pregnant or nursing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorothy Hatsukami, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

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Novel Determinants and Measures of Smokeless Tobacco Use: Study 2

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