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

NCT00717093

Last updated date
Study Location
Pfizer Investigational Site
Floro, , 6900, Norway
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tobacco Use Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Tobacco Use CessationStudy Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use
NCT00717093
  1. Floro,
  2. Hafrsfjord,
  3. Hamar,
  4. Hønefoss,
  5. Oslo,
  6. Radal,
  7. Trondheim,
  8. Göteborg,
  9. Helsingborg,
  10. Jarfalla,
  11. Karlstad,
  12. Orebro,
  13. Sodertalje,
  14. Stockholm,
  15. Sundsvall,
  16. Umea,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use
Official Title  ICMJE A Randomized, Multicenter, Double Blind, Placebo Controlled Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use
Brief Summary The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tobacco Use Cessation
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: Active
    Intervention: Drug: Varenicline Tartrate
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Fagerström 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2008)
432
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00717093
Other Study ID Numbers  ICMJE A3051104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP