Tobacco Use Disorder
Conditions
Keywords
Brand Switching, smokeless tobacco use
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.
Interventions
OTHERLower Nicotine Smokeless Tobacco Product
Skoal for 50% reduction;Skoal bandits for 75% reduction.
Behavioral counseling alone for reduction in tobacco use.
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| Motivation and self-efficacy (measured at Week 8, and 12 and 26 weeks following treatment completion) | 26 weeks |
Countries
United States
Outcome results
None listed