Effectiveness of Using Tobacco Free Snuff in Reducing Negative Effects of Smokeless Tobacco Use

Spit tobacco presents as many health risks to its users as smoking tobacco. 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 using tobacco-free snuff 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 will be randomly assigned to receive either treatment with tobacco-free snuff
or treatment without it. All participants will be encouraged to reduce nicotine intake by
50% during the first four weeks and by 75% the following four weeks. Participants receiving
the tobacco-free snuff will be asked to alternate the use of their usual brand of ST with
tobacco-free snuff in order to achieve the targeted reduction. Participants not receiving
the tobacco-free snuff will only be informed to try to cut down their tobacco use to the
targeted reduction. Study visits will occur once weekly during the 8-week treatment period.
Assessments will include vital signs, physiological measures related to tobacco use, and
measures of motivation and self-efficacy to quit ST. The number of participants who either
do not complete treatment, reduce nicotine intake, or quit completely will be assessed at
the Week 8 study visit and at follow-up visits, which will be held at Weeks 12 and 26.

Inclusion Criteria:

- Not interested in quitting smokeless tobacco use within 90 days of study entry

- Used smokeless tobacco at least six times a day for 6 months prior to study entry

- Agree to use an effective form of contraception throughout the study

Exclusion Criteria:

- Current use of tobacco or nicotine products other than ST

- 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