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

A Randomized, Multicenter, Double Blind, Placebo Controlled 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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Cessation
• Intervention / Treatment: Drug: Varenicline Tartrate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 432
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Floro, Norway, 6900
    • Pfizer Investigational Site
  • Hafrsfjord, Norway, 4042
    • Pfizer Investigational Site
  • Hamar, Norway, 2317
    • Pfizer Investigational Site
  • Hønefoss, Norway, 3515
    • Pfizer Investigational Site
  • Oslo, Norway, 0407
    • Pfizer Investigational Site
  • Radal, Norway, 5235
    • Pfizer Investigational Site
  • Trondheim, Norway, 7034
    • Pfizer Investigational Site
• Sweden
  • 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
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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 Names: Champix, Chantix, CP-526,555

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Fagerstrom K, Gilljam H, Metcalfe M, Tonstad S, Messig M. Stopping smokeless tobacco with varenicline: randomised double blind placebo controlled trial. BMJ. 2010 Dec 6;341:c6549. doi: 10.1136/bmj.c6549.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: July 15, 2008
• First Submitted That Met QC Criteria: July 15, 2008
• First Posted (Estimate): July 16, 2008

Study Record Updates

• Last Update Posted (Estimate): July 23, 2015
• Last Update Submitted That Met QC Criteria: June 30, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: A3051104