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

Study Overview
=================
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. Long-term effects of smokeless tobacco (ST) include tooth abrasion, gum recession, mouth disease, loss of bone in the jaw, yellowing of teeth, and chronic bad breath. 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.

Detailed Description
-----------------
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.

Official Title
-----------------
Treatment of Smokeless Tobacco Users

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Drug: Tobacco free snuff


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Reduction of tobacco use by substituting tobacco free snuff. | Drug: Tobacco free snuff<br>* Tobacco free snuff<br>* Other names: Smokey Mountain;|
| Placebo Comparator: 2<br>Reduction of tobacco use by using behavioral techniques. | Drug: Tobacco free snuff<br>* Tobacco free snuff<br>* Other names: Smokey Mountain;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in use |  | Week 8, 12, and 26 | 
| Toxicity profile of carcinogen metabolites |  | Week 8, 12, and 26 | 
| Number of unsuccessful quit attempts |  | Week 8, 12, and 26 | 
| Abstinence (measured at Weeks 8, 12, and 26) |  | Week 8, 12, and 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation and self-efficacy (measured at Weeks 8, 12, and 26) |  | Week 8, 12, and 26 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smokeless tobacco, harm reduction