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

Phase 1

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Other: Lower Nicotine Smokeless Tobacco Product; Other: Behavioral Counseling

• Registration Number: NCT00218244
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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 Timeline

• Study Start: 2001-08
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Status Verified: 2008-06
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Controlled use	Lower Nicotine Smokeless Tobacco Product	Reduction in tobacco toxicants by switching to a lower nicotine tobacco product under a controlled use condition.
2 Uncontrolled use	Lower Nicotine Smokeless Tobacco Product	Reduction in tobacco toxicants by switching to a lower nicotine tobacco product under an uncontrolled use condition.
3 Behavioral	Behavioral Counseling	Reduction in smokeless tobacco use using behavioral techniques only.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Motivation and self-efficacy (measured at Week 8, and 12 and 26 weeks following treatment completion)	26 weeks

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States