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

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

Tracking Information

• First Submitted Date: September 16, 2005
• First Posted Date: September 22, 2005
• Last Update Posted Date: January 10, 2017
• Study Start Date: August 2001
• Actual Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: September 16, 2005)

• Percent reduction in use
• Toxicity profile of carcinogen metabolites
• Number of unsuccessful quit attempts
• Abstinence

• Current Secondary Outcome Measures (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 (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: Using Smokeless Tobacco Products With Lower Nicotine Levels to Reduce Negative Effects of Smokeless Tobacco Use
• Official Title: 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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Tobacco Use Disorder

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 27, 2008): 56
• Original Enrollment (submitted: September 16, 2005): 40
• Actual Study Completion Date: November 2004
• Actual Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00218244
• Other Study ID Numbers: NIDA-14404-1; R01-14404-1; DPMC
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dorothy Hatuskami, University of Minnesota
• Study Sponsor: National Institute on Drug Abuse (NIDA)
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dorothy Hatsukami, PhD; University of Minnesota

• PRS Account: National Institute on Drug Abuse (NIDA)
• Verification Date: June 2008