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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Tobacco Use Cessation

Treatments: Drug: Placebo; Drug: Varenicline Tartrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00717093

A3051104

Details and patient eligibility

About

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

Enrollment: 432 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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432 participants in 2 patient groups, including a placebo group

Active

Experimental group

Treatment:

Drug: Varenicline Tartrate

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo