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Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use

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ClinicalTrials.gov Identifier: NCT00218296
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : December 19, 2013
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks associated with its use. While treatment programs that focus on stopping tobacco use may be effective, past research has shown that interventions that specifically focus on reducing tobacco use may be equally effective and may motivate individuals to eventually quit using tobacco. This study will compare the effectiveness of a ST reduction treatment program versus a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Usual Care Group Other: Reduction Group Phase 2

Detailed Description:

Individuals who use ST are at increased risk for cancer or dying from cardiovascular disease. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Many individuals who use ST recognize the health risks associated with ST, but either do not want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. By participating in a tobacco reduction program, these individuals may be motivated to eventually stop using tobacco altogether. The purpose of this study is to compare a ST reduction treatment program versus a standard tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.

This study will enroll regular users of ST. Participants will be randomly assigned to either a tobacco reduction program or to usual care, a standard tobacco cessation program during the first telephone contact. At the first clinic visit, participants assigned to the tobacco Reduction Group will replace their usual brand of ST with one of two options: an ST brand with less nicotine or nicotine lozenge. Participants will be encouraged to reduce their nicotine intake by at least 50% the first two weeks and encouraged to further reduce their nicotine intake in the following 4 weeks. Participants assigned to the Usual Care Group will be advised to quit and will be asked to set a quit date within two weeks. Telephone counseling, ideas on methods for sustaining cessation, and a self-help manual will also be provided along with a 2 week supply of nicotine patches. Study visits will occur at 2, 4, 8, 12, 26, and 32 (for reduction group) weeks. Outcome assessments will include vital signs, physiological measures related to tobacco use, levels of nicotine reduction, tobacco use status, and measures of motivation and self-efficacy to quit.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Smokeless Tobacco Users
Study Start Date : November 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Usual Care Group
Usual care for cessation with immediate quit date scheduled and two weeks of nicotine patch supplied.
Drug: Usual Care Group
Nicotine replacement therapy
Other Names:
  • 21 mg Nicotine Patch
  • Nicoderm
Experimental: Reduction Group
Reduction in nicotine exposure for 6 weeks prior to quit date using medicinal nicotine lozenge or reduced nicotine smokeless tobacco.
Other: Reduction Group
Subject selects preferred method for reduction.
Other Names:
  • Commit Nicotine Lozenge or
  • Reduced nicotine smokeless tobacco products (Skoal, Skoal Bandits)



Primary Outcome Measures :
  1. Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence) [ Time Frame: 12 weeks ]
    No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO)

  2. Percent Prolonged Abstinence From Tobacco at Week 12 [ Time Frame: 12 weeks ]
    Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO)

  3. Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence) [ Time Frame: 26 week ]
    Abstinence from tobacco 7 days prior to Week 26 (Assessed at 26 weeks for Usual Care and 20 weeks for Reduction Group post-quit date)

  4. Percent Prolonged Abstinence From Tobacco at Week 26 [ Time Frame: 26 weeks ]
    Continuous Abstinence from quit date through Week 26 (Assessed at Week 26 for Usual Care and Week 20 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).

  5. Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence) [ Time Frame: 32 Weeks ]
    Abstinence from tobacco 7 days prior to Week 26 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group. Reduction Group's quit date is 6 weeks later than Usual Care).

  6. Percent Prolonged Abstinence From Tobacco at Week 32 [ Time Frame: 32 Weeks ]
    Continuous Abstinence from quit date through Week 32 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No interest in stopping ST use within 90 days of study entry
  • Daily use of ST in the 6 months prior to study entry

Exclusion Criteria:

  • Current use of tobacco or nicotine products, other than ST
  • Current unstable medical and mental health conditions
  • Use of any medication that may affect tobacco use or be affected by a reduction in tobacco use
  • Pregnant or breastfeeding

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): NCT00218296


Locations
United States, Minnesota
Univerisity of Minnesota
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Dorothy Hatsukami, PhD University of Minnesota - Clinical and Translational Science Institute

Additional Information:
Publications of Results:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00218296     History of Changes
Other Study ID Numbers: NIDA-14404-4
R01-DA14404-4
DPMCDA
First Posted: September 22, 2005    Key Record Dates
Results First Posted: December 19, 2013
Last Update Posted: October 16, 2017
Last Verified: September 2017

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Nicotine Dependence
Tobacco Dependence

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