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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00717093
First received: July 15, 2008
Last updated: July 13, 2010
Last verified: July 2010
  Purpose

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


Condition Intervention Phase
Tobacco Use Cessation
Drug: Varenicline Tartrate
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double Blind, Placebo Controlled Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco [ Time Frame: Weeks 9 through 12 ] [ Designated as safety issue: No ]
    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:
  • Number of Subjects With Continuous Abstinence (CA) of Smokeless Tobacco Use [ Time Frame: Week 9 through 12, Week 26 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 12, Week 26 ] [ Designated as safety issue: No ]
    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.


Enrollment: 432
Study Start Date: August 2008
Study Completion Date: July 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active 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.
Other Name: Champix, Chantix, CP-526,555
Placebo Comparator: Placebo Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717093

Locations
Norway
Pfizer Investigational Site
Hamar, 2317, Norway
Pfizer Investigational Site
5235 Radal, Norway
Pfizer Investigational Site
Floro, Norway, 6900
Pfizer Investigational Site
Hafrsfjord, Norway, 4042
Pfizer Investigational Site
Hønefoss, Norway, 3515
Pfizer Investigational Site
Oslo, Norway, 0407
Pfizer Investigational Site
Trondheim, Norway, 7034
Sweden
Pfizer Investigational Site
Göteborg, Sweden, 413 45
Pfizer Investigational Site
Helsingborg, Sweden, 254 52
Pfizer Investigational Site
Jarfalla, Sweden, 177 31
Pfizer Investigational Site
Karlstad, Sweden, 652 24,
Pfizer Investigational Site
Orebro, Sweden, 701 85
Pfizer Investigational Site
Sodertalje, Sweden, 151 87
Pfizer Investigational Site
Stockholm, Sweden, 118 91
Pfizer Investigational Site
Sundsvall, Sweden, 852 31
Pfizer Investigational Site
Umea, Sweden, 901 85
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00717093     History of Changes
Other Study ID Numbers: A3051104
Study First Received: July 15, 2008
Results First Received: April 15, 2010
Last Updated: July 13, 2010
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Lobeline
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014