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Completed

NCT Number: NCT01067599

Novel Determinants and Measures of Smokeless Tobacco Use: Study 2

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

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Key information

Conditions

Tobacco Use Disorder Behavior Chemically-Induced Disorders Mental Disorders Nicotine Dependence Substance-Related Disorders Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low nicotine

Other

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

Medium nicotine

Other

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

High nicotine

Other

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

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.

    Time frame: 8 weeks

Secondary outcomes

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

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Feb 11, 2010
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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