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

Tobacco Use Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717093
• Other study ID #: A3051104
• Status: Completed
• Phase: Phase 4
• First received: July 15, 2008
• Last updated: June 30, 2015
• Start date: August 2008
• Est. completion date: July 2009

Study information

• Verified date: June 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 432
• Est. completion date: July 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Drug:
• Varenicline Tartrate
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.
• Placebo
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.

Locations

Country	Name	City	State
Norway	Pfizer Investigational Site	Floro
Norway	Pfizer Investigational Site	Hafrsfjord
Norway	Pfizer Investigational Site	Hamar
Norway	Pfizer Investigational Site	Hønefoss
Norway	Pfizer Investigational Site	Oslo
Norway	Pfizer Investigational Site	Radal
Norway	Pfizer Investigational Site	Trondheim
Sweden	Pfizer Investigational Site	Göteborg
Sweden	Pfizer Investigational Site	Helsingborg
Sweden	Pfizer Investigational Site	Jarfalla
Sweden	Pfizer Investigational Site	Karlstad
Sweden	Pfizer Investigational Site	Orebro
Sweden	Pfizer Investigational Site	Sodertalje
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Sundsvall
Sweden	Pfizer Investigational Site	Umea

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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