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Novel Determinants and Measures of Smokeless Tobacco Use: Study 2

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by University of Minnesota - Clinical and Translational Science Institute.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01067599
First Posted: February 11, 2010
Last Update Posted: October 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
The research project will determine the level of nicotine in ST products that will lead to the greatest reduction in toxicant exposure

Condition Intervention Phase
Tobacco Use Disorder Nicotine Dependence Other: Low nicotine Other: Medium nicotine Other: High nicotine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

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 ]

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

Estimated Enrollment: 300
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067599


Contacts
Contact: Joni Jensen, MPH 612-624-5178 jense010@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Joni Jensen, MPH    612-624-5178    jense010@umn.edu   
Contact: Katie Schiller, PhD    612-624-4983    schil0534@umn.edu   
Principal Investigator: Dorothy Hatsukami, Ph.D.         
United States, Oregon
Oregon Research Institute Recruiting
Eugene, Oregon, United States, 97403
Contact: Julia Martin    541-484-2123      
Principal Investigator: Herb Severson, PhD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Cancer Institute (NCI)
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Dorothy Hatsukami, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01067599     History of Changes
Other Study ID Numbers: 1R01CA141531-01 ( U.S. NIH Grant/Contract )
1R01CA141531 ( U.S. NIH Grant/Contract )
First Submitted: February 10, 2010
First Posted: February 11, 2010
Last Update Posted: October 18, 2013
Last Verified: October 2013

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Biomarkers of tobacco exposure
Smokeless Tobacco

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Lobeline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents