Clinical trial NCT00218244: Using Smokeless Tobacco Products With Lower Nicotine Levels to Reduce Negative Effects of Smokeless Tobacco Use
Official title: Treatment of Smokeless Tobacco Users: Use of Nicotine Replacement Products to Reduce Smokeless Tobacco Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Tobacco Use Disorder
Keywords: Brand Switching, smokeless tobacco use
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2005-09-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percent reduction in ST use
timeFrame: 26 weeks
measure: Toxicity profile of carcinogen metabolites
timeFrame: 26 weeks
measure: Number of unsuccessful quit attempts
timeFrame: 26 weeks
measure: Abstinence from ST use (measured at Week 8, and 12 and 26 weeks following treatment completion)
timeFrame: 26 weeks
Secondary outcomes:
measure: Motivation and self-efficacy (measured at Week 8, and 12 and 26 weeks following treatment completion)
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, PhD
role: PRINCIPAL_INVESTIGATOR
References: