NCT00218244

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tobacco Use Disorder

Interventions

Type	Name	Description
OTHER	Lower Nicotine Smokeless Tobacco Product	Skoal for 50% reduction;Skoal bandits for 75% reduction.
OTHER	Behavioral Counseling	Behavioral counseling alone for reduction in tobacco use.

Timeline

• Start date: 2001-08-01
• Primary completion: 2004-11-01
• Completion: 2004-11-01
• First posted: 2005-09-22
• Last updated: 2017-01-10

Locations

1 site across 1 country: United States