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

NCT00717093 | Completed Phase 4 Results

• 1 other identifier: A3051104
• Study Type: interventional
• Target: 432
• Locations: 2 countries
• Sites: 16

Brief Summary

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

Conditions

Tobacco Use Cessation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Week 9 through 12, Week 26

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

  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)

  Week 12, Week 26

Study Arms (2)

Active

EXPERIMENTAL

Drug: Varenicline Tartrate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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.

Also known as: Champix, Chantix, CP-526,555

Active

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (16)

Pfizer Investigational Site

Florø, 6900, Norway

Location

Pfizer Investigational Site

Hafrsfjord, 4042, Norway

Location

Pfizer Investigational Site

Hamar, 2317, Norway

Location

Pfizer Investigational Site

Hønefoss, 3515, Norway

Location

Pfizer Investigational Site

Oslo, 0407, Norway

Location

Pfizer Investigational Site

Rådal, 5235, Norway

Location

Pfizer Investigational Site

Trondheim, 7034, Norway

Location

Pfizer Investigational Site

Gothenburg, 413 45, Sweden

Location

Pfizer Investigational Site

Helsingborg, 254 52, Sweden

Location

Pfizer Investigational Site

Jarfalla, 177 31, Sweden

Location

Pfizer Investigational Site

Karlstad, 652 24,, Sweden

Location

Pfizer Investigational Site

Örebro, 701 85, Sweden

Location

Pfizer Investigational Site

Södertälje, 151 87, Sweden

Location

Pfizer Investigational Site

Stockholm, 118 91, Sweden

Location

Pfizer Investigational Site

Sundsvall, 852 31, Sweden

Location

Pfizer Investigational Site

Umeå, 901 85, Sweden

Location

Related Publications (2)

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

  PMID: 37142273 DERIVED

• 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.

  PMID: 21134997 DERIVED

Related Links

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

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 16, 2008
• Study Start: August 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 23, 2015
• Results First Posted: May 18, 2010

Record last verified: 2015-06

Locations

NO (7); SE (9)