Nicotine Lozenge to Reduce Smokeless Tobacco Use

Study Overview
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Brief Summary
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Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has as many health risks associated with its use as cigarettes. While there are many treatment programs that focus on stopping tobacco use, there are no interventions that specifically focus on reducing tobacco use. This study will evaluate the effectiveness of nicotine lozenge at reducing tobacco use in ST users.

Detailed Description
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Individuals who use ST are at risk for developing heart disease, stroke, high blood pressure, and cancer. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Many individuals who use ST recognize the health risks associated with ST, but either do not want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. The need exists for a program specifically aimed towards reducing, rather than quitting, tobacco use. The purpose of this study is to evaluate the effectiveness of nicotine gum at reducing ST use, as well as assessing the motivation to either quit or sustain lower levels of ST use. This 8-week study will enroll frequent users of ST. Participants will be randomly assigned to receive either nicotine lozenge plus behavioral counseling or behavioral counseling alone. All participants will be asked to alternate use of their usual ST brand with nicotine lozenge or placebo in order to reduce nicotine intake by 50% during the first 4 weeks and by 75% the following 4 weeks. Participants will be required to maintain a daily tobacco use diary. Study visits will occur once a week. Tobacco levels will be monitored with urine tests, and questionnaires will be completed to assess tobacco use. Follow-up evaluations will occur 12 and 26 weeks following the end of treatment.

Official Title
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Treatment of Smokeless Tobacco Users

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Drug: Nicotine Lozenge
* Behavioral: Behavioral Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No interest in stopping ST use within 90 days of study entry Using ST at least 6 times a day in the 6 months prior to study entry Willing to use contraception throughout the study Exclusion Criteria: Current use of tobacco or nicotine products, other than ST Current unstable medical condition Use of any medication that may affect tobacco use or be affected by a reduction in tobacco use Meets DSM-IV diagnostic criteria for any psychiatric disorder or substance abuse disorder within 6 months of study entry Use of any psychotropic medication within 6 months of study entry Pregnant or breastfeeding

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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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 - Nicotine Lozenge<br>Use of nicotine lozenge plus behavioral counseling to help reduce tobacco use prior to quit date. | Drug: Nicotine Lozenge<br>* Oral Nicotine replacement product<br>* Other names: Commite Nicotine lozenge;|
| Placebo Comparator: 2 Behavioral counseling<br>Use of behavioral counseling alone to help reduce tobacco use prior to quit date. | Behavioral: Behavioral Counseling<br>* Use of behavioral counseling to reduce tobacco use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in tobacco use (measured by tobacco daily diary at Week 8, and the 12- and 26-week follow-up evaluations) |  | 8, 12 and 26 weeks | 
| Toxicity profile of carcinogen metabolites (measured by urine screens at Week 8, and the 12- and 26-week follow-up evaluations) |  | 8, 12 and 26 weeks | 
| Number of unsuccessful attempts to quit using tobacco (measured by tobacco use questionnaire at Week 8, and the 12- and 26-week follow-up evaluations) |  | 8, 12 and 26 weeks | 
| Abstinence from tobacco (measured by tobacco use questionnaire at Week 8, and the 12- and 26-week follow-up evaluations) |  | 8, 12 and 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation and self-efficacy (measured by a questionnaire at Week 8, and the 12- and 26-week follow-up evaluations) |  | 8, 12 and 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine Dependence, Tobacco Dependence