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

Phase 4

Completed

• Conditions: Tobacco Use Cessation
• Interventions: Drug: Placebo; Drug: Varenicline Tartrate

• Registration Number: NCT00717093
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-15
• Study First Submitted QC: 2008-07-15
• Study First Posted: 2008-07-16
• Study Start: 2008-08
• Primary Completion: 2009-04
• Study Completion: 2009-07
• Results First Submitted: 2010-04-15
• Results First Submitted QC: 2010-04-15
• Results First Posted: 2010-05-18
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-30
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 432

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Active	Varenicline Tartrate	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco	Weeks 9 through 12	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Continuous Abstinence (CA) of Smokeless Tobacco Use	Week 9 through 12, Week 26	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.
Number of Subjects With Long Term Quit Rate (LTQR) of Smokeless Tobacco	Week 26	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.
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)	Week 12, 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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇪 Umea, Sweden