Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use

Study Overview
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Brief Summary
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The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco.

Official Title
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A Randomized, Multicenter, Double Blind, Placebo Controlled Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use

Conditions
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Tobacco Use Cessation

Intervention / Treatment
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* Drug: Varenicline Tartrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female daily smokeless tobacco users aged 18 years and older, who are motivated to stop use of all tobacco products. Subjects must be daily users of nicotine containing smokeless tobacco and using smokeless tobacco on at least 8 occasions per day averaged over a week. Have used smokeless tobacco for at least 1 year prior to screening with no period of abstinence >3 months in the past year. Exclusion Criteria: Subjects using nicotine containing products (including smoking tobacco) other than smokeless tobacco for 3 months prior to screening. Subjects with exhaled Carbon Monoxide (CO) >10 ppm at baseline. Subjects who have used varenicline, bupropion, or NRT within 3 months of screening. Subjects currently or within the past 12 months requiring treatment for depression or have a current or prior history of panic disorder, psychosis, bipolar disorder or any other serious mental illness.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Drug: Varenicline Tartrate<br>* Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.<br>* Other names: Champix, Chantix, CP-526,555;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco | Number of subjects who reported no use of nicotine-containing products by answering No to the nicotine use inventory (NUI) question: Has the subject used any nicotine-containing products in the last 7 days (Week 9) or since last study visit (Week 10 through 12) and confirmed salivary cotinine <= 15 ng/mL. | Weeks 9 through 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Continuous Abstinence (CA) of Smokeless Tobacco Use | Number of subjects who remainded abstinent from the period defined as start of the primary endpoint (Week 9) through the end of follow up (Week 26) by reporting no use of nicotine-containing products and confirmed salivary cotinine <= 15 ng/mL. | Week 9 through 12, Week 26 | 
| Number of Subjects With Long Term Quit Rate (LTQR) of Smokeless Tobacco | Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of using nicotine containing products from Week 12 through Week 26. | Week 26 | 
| Number of Subjects With 7-day Point Prevalence (PP) of Abstinence at the End of Treatment (Week 12) and at the End of Study (Week 26) | Number of subjects at Week 12 and Week 26 reporting no use of nicotine-containing products in the last 7 days and confirmed salivary cotinine <= 15 ng/mL. | Week 12, Week 26 |