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Using Smokeless Tobacco Products With Lower Nicotine Levels to Reduce Negative Effects of Smokeless Tobacco Use (Brandswitch)

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ClinicalTrials.gov Identifier: NCT00218244
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 10, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE September 16, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date January 10, 2017
Study Start Date  ICMJE August 2001
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
  • Percent reduction in ST use [ Time Frame: 26 weeks ]
  • Toxicity profile of carcinogen metabolites [ Time Frame: 26 weeks ]
  • Number of unsuccessful quit attempts [ Time Frame: 26 weeks ]
  • Abstinence from ST use (measured at Week 8, and 12 and 26 weeks following treatment completion) [ Time Frame: 26 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
  • Percent reduction in use
  • Toxicity profile of carcinogen metabolites
  • Number of unsuccessful quit attempts
  • Abstinence
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
Motivation and self-efficacy (measured at Week 8, and 12 and 26 weeks following treatment completion) [ Time Frame: 26 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
Motivation and self-efficacy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Smokeless Tobacco Products With Lower Nicotine Levels to Reduce Negative Effects of Smokeless Tobacco Use
Official Title  ICMJE Treatment of Smokeless Tobacco Users: Use of Nicotine Replacement Products to Reduce Smokeless Tobacco Use
Brief Summary Though spit tobacco is smokeless, it still affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. This study will assess the effectiveness of limiting smokeless tobacco (ST) nicotine intake in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.
Detailed Description

Spit tobacco presents as many health risks to its users as smoking tobacco. It affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. Long-term effects of spit tobacco use include tooth abrasion, gum recession, mouth disease, bone loss in the jaw, yellowing of the teeth, and chronic bad breath. Although a significant number of ST users recognize the importance of quitting, many either do not want to quit or feel it is impossible. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting, or as a treatment endpoint; however, approaches to help ST users reach this goal have not been studied. This study will assess the effectiveness of limiting ST nicotine intake in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.

Participants in this open-label study will be randomly assigned to one of three treatment conditions: switching to an ST brand with less concentrated nicotine and controlling for ST use; switching to an ST brand with less concentrated nicotine, combined with no limit on ST intake; or continued use of usual ST brand with no limit on intake (control group). Participants in both brand-switching conditions will use ST brands that have 50% less nicotine than their usual ST brands for the first 4 weeks. For the next 4 weeks, participants in the brand-switching conditions will use ST brands that have 75% less nicotine that their usual ST brands. Study visits will ocur once weekly during the 8-week treatment period. The number of participants who do not complete treatment, reduce nicotine intake, or quit completely will be assessed at Week 8 and at follow-up visits, which will be held 12 and 26 weeks following the completion of treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tobacco Use Disorder
Intervention  ICMJE
  • Other: Lower Nicotine Smokeless Tobacco Product
    Skoal for 50% reduction;Skoal bandits for 75% reduction.
    Other Name: Skoal and Skoal Bandits
  • Other: Behavioral Counseling
    Behavioral counseling alone for reduction in tobacco use.
Study Arms  ICMJE
  • Active Comparator: 1 Controlled use
    Reduction in tobacco toxicants by switching to a lower nicotine tobacco product under a controlled use condition.
    Intervention: Other: Lower Nicotine Smokeless Tobacco Product
  • Active Comparator: 2 Uncontrolled use
    Reduction in tobacco toxicants by switching to a lower nicotine tobacco product under an uncontrolled use condition.
    Intervention: Other: Lower Nicotine Smokeless Tobacco Product
  • Placebo Comparator: 3 Behavioral
    Reduction in smokeless tobacco use using behavioral techniques only.
    Intervention: Other: Behavioral Counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2008)
56
Original Enrollment  ICMJE
 (submitted: September 16, 2005)
40
Actual Study Completion Date  ICMJE November 2004
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Not interested in quitting ST use within 90 days of study entry
  • Has been using ST at least six times a day for 6 months prior to study entry
  • Agrees to use an effective form of contraception throughout the study

Exclusion Criteria:

  • Current use of other tobacco or nicotine products
  • Pregnant or breastfeeding
  • Any unstable medical condition
  • Use of any medication that may affect tobacco use or be affected by reduction of tobacco use
  • DSM-IV diagnosis of any psychiatric disorders or substance abuse disorders within 6 months prior to study entry
  • Use of any psychotropic medications within 6 months prior to study entry
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00218244
Other Study ID Numbers  ICMJE NIDA-14404-1
R01-14404-1
DPMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dorothy Hatuskami, University of Minnesota
Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dorothy Hatsukami, PhD University of Minnesota
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date June 2008

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