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

Treatment of Smokeless Tobacco Users: Use of Nicotine Replacement Products to Reduce Smokeless Tobacco Use

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Other: Lower Nicotine Smokeless Tobacco Product; Other: Behavioral Counseling

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
• Enrollment (Actual): 56
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent reduction in ST use	26 weeks
Toxicity profile of carcinogen metabolites	26 weeks
Number of unsuccessful quit attempts	26 weeks
Abstinence from ST use (measured at Week 8, and 12 and 26 weeks following treatment completion)	26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Motivation and self-efficacy (measured at Week 8, and 12 and 26 weeks following treatment completion)	26 weeks

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start: August 1, 2001
• Primary Completion (Actual): November 1, 2004
• Study Completion (Actual): November 1, 2004

Study Registration Dates

• First Submitted: September 16, 2005
• First Submitted That Met QC Criteria: September 16, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Brand Switching, smokeless tobacco use
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Respiratory System Agents; Nicotine; Lobeline
• Other Study ID Numbers: NIDA-14404-1; DPMC (Other Identifier: NIDA); R01-14404-1