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Novel Determinants and Measures of Smokeless Tobacco Use: Study 2

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ClinicalTrials.gov Identifier: NCT01067599
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : February 26, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Nicotine Dependence Other: Low nicotine Other: Medium nicotine Other: High nicotine Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
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
Actual Study Start Date : March 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  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. [ Time Frame: 8 weeks ]

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


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.

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


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
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

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 Posted: February 11, 2010    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

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