Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00218296
First received: September 16, 2005
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Tobacco Use Disorder
Drug: Usual Care Group
Other: Reduction Group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Smokeless Tobacco Users

Resource links provided by NLM:


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

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

  • Percent Prolonged Abstinence From Tobacco at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO)

  • Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence) [ Time Frame: 26 week ] [ Designated as safety issue: No ]
    Abstinence from tobacco 7 days prior to Week 26 (Assessed 26 weeks for Usual Care and 20 weeks for Reduction Group post-quit date)

  • Percent Prolonged Abstinence From Tobacco at Week 26 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Continuous Abstinence from quit date through Week 26 (Week 26 for Usual Care and Week 20 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).

  • Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence) [ Time Frame: 32 Weeks ] [ Designated as safety issue: No ]
    Abstinence from tobacco 7 days prior to Week 26 (Week 32 for Usual Care and Week 26 for Reduction Group. Reduction Group's quit date is 6 weeks later than Usual Care).

  • Percent Prolonged Abstinence From Tobacco at Week 32 [ Time Frame: 32 Weeks ] [ Designated as safety issue: No ]
    Continuous Abstinence from quit date through Week 32 (Week 32 for Usual Care and Week 26 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).


Enrollment: 332
Study Start Date: November 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
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
Study First Received: September 16, 2005
Results First Received: October 29, 2013
Last Updated: March 26, 2014
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014