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

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.

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