Novel Determinants and Measures of Smokeless Tobacco Use: Study 2

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01067599
First received: February 10, 2010
Last updated: October 17, 2013
Last verified: October 2013

February 10, 2010
October 17, 2013
March 2012
October 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01067599 on ClinicalTrials.gov Archive Site
To determine the extent to which varying low nicotine ST products leads to compensatory tobacco use. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To determine the extent to which varying low nicotine ST products leads to compensatory tobacco use. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Novel Determinants and Measures of Smokeless Tobacco Use: Study 2
Novel Determinants and Measures of Smokeless Tobacco Use: Study 2 Effects of Switching Levels of Nicotine and TSNA in Products on Smokeless Tobacco Use

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Tobacco Use Disorder
  • Nicotine Dependence
  • Other: Low nicotine
    Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
  • Other: Medium nicotine
    Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
  • 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
    Intervention: 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.
    Intervention: Other: Medium nicotine
  • 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
    Intervention: Other: High nicotine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2014
October 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: Joni Jensen, MPH 612-624-5178 jense010@umn.edu
United States
 
NCT01067599
1R01CA141531-01, 1R01CA141531
Yes
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
  • National Cancer Institute (NCI)
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Dorothy Hatsukami, PhD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP