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

Tobacco Use Disorder Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218244
• Other study ID #: NIDA-14404-1
• Secondary ID: R01-14404-1DPMC
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 16, 2005
• Last updated: January 9, 2017
• Start date: August 2001
• Est. completion date: November 2004

Study information

• Verified date: June 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Other:
• Lower Nicotine Smokeless Tobacco Product
Skoal for 50% reduction;Skoal bandits for 75% reduction.
• Behavioral Counseling
Behavioral counseling alone for reduction in tobacco use.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction in ST use		26 weeks	No
Primary	Toxicity profile of carcinogen metabolites		26 weeks	No
Primary	Number of unsuccessful quit attempts		26 weeks	No
Primary	Abstinence from ST use (measured at Week 8, and 12 and 26 weeks following treatment completion)		26 weeks	No
Secondary	Motivation and self-efficacy (measured at Week 8, and 12 and 26 weeks following treatment completion)		26 weeks	No