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Completed

NCT Number: NCT00717093

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

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

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Key information

Conditions

Tobacco Use Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Florø, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

varenicline tartrate

Drug

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.

Other names: Champix, Chantix, CP-526,555

Placebo

Drug

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.

Primary outcomes

  1. Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco

    Time frame: 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 outcomes

  1. Number of Subjects With Continuous Abstinence (CA) of Smokeless Tobacco Use

    Time frame: 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.

  2. Number of Subjects With Long Term Quit Rate (LTQR) of Smokeless Tobacco

    Time frame: 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.

  3. 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 16, 2008
Registry last updated
Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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