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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218244
First received: September 16, 2005
Last updated: June 27, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Tobacco Use Disorder
Other: Lower Nicotine Smokeless Tobacco Product
Other: Behavioral Counseling
Phase 1
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: Use of Nicotine Replacement Products to Reduce Smokeless Tobacco Use

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Percent reduction in ST use [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Toxicity profile of carcinogen metabolites [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Number of unsuccessful quit attempts [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Abstinence from ST use (measured at Week 8, and 12 and 26 weeks following treatment completion) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Motivation and self-efficacy (measured at Week 8, and 12 and 26 weeks following treatment completion) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: August 2001
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Controlled use
Reduction in tobacco toxicants by switching to a lower nicotine tobacco product under a controlled use condition.
Other: Lower Nicotine Smokeless Tobacco Product
Skoal for 50% reduction;Skoal bandits for 75% reduction.
Other Name: Skoal and Skoal Bandits
Active Comparator: 2 Uncontrolled use
Reduction in tobacco toxicants by switching to a lower nicotine tobacco product under an uncontrolled use condition.
Other: Lower Nicotine Smokeless Tobacco Product
Skoal for 50% reduction;Skoal bandits for 75% reduction.
Other Name: Skoal and Skoal Bandits
Placebo Comparator: 3 Behavioral
Reduction in smokeless tobacco use using behavioral techniques only.
Other: Behavioral Counseling
Behavioral counseling alone for reduction in tobacco use.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00218244

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Investigators
Principal Investigator: Dorothy Hatsukami, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Dorothy Hatuskami, University of Minnesota
ClinicalTrials.gov Identifier: NCT00218244     History of Changes
Other Study ID Numbers: NIDA-14404-1, R01-14404-1, DPMC
Study First Received: September 16, 2005
Last Updated: June 27, 2008
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
Brand Switching, smokeless tobacco use

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Lobeline
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014