An Alternative Dosing Schedule of Varenicline for Smoking Cessation

NCT00835900

Last updated date
Study Location
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- currently smoking at least 15 cigarettes daily

- in good health

- able to read and speak English fluently

- have a home telephone and plan to reside in Western New York for 6 months

- willing to make quit attempt

- signed informed consent

- who planned quit attempt.

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


- serious medical condition


- depression or mental health condition requiring treatment in the past year


- history of panic disorder, psychosis, bipolar disorder


- alcohol or drug abuse in the past year


- use of tobacco products other than cigarettes


- current use of other cessation pharmacotherapies


- pregnancy/planned pregnancy.

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Advanced Information
Descriptive Information
Brief Title  ICMJE An Alternative Dosing Schedule of Varenicline for Smoking Cessation
Official Title  ICMJE Extended Varenicline for Smoking Cessation: A Pilot Study
Brief Summary The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.
Detailed Description This pilot study will utilize a two group randomized design. Adult smokers who are motivated to quit smoking will be randomized to one of two treatment groups. Both groups will receive brief support counseling. During a one-week baseline and the 4-week pre-quit period smoking rate, smoking satisfaction, withdrawal, and craving will be assessed on a daily basis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: varenicline
    variable dosing schedule
    Other Name: Chantix
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Experimental: varenicline
    drug plus counseling.
    Intervention: Drug: varenicline
  • Active Comparator: placebo
    placebo plus counseling
    Intervention: Drug: placebo
Publications * Not Provided

*   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: February 3, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • currently smoking at least 15 cigarettes daily
  • in good health
  • able to read and speak English fluently
  • have a home telephone and plan to reside in Western New York for 6 months
  • willing to make quit attempt
  • signed informed consent
  • who planned quit attempt.

Exclusion Criteria:

  • serious medical condition
  • depression or mental health condition requiring treatment in the past year
  • history of panic disorder, psychosis, bipolar disorder
  • alcohol or drug abuse in the past year
  • use of tobacco products other than cigarettes
  • current use of other cessation pharmacotherapies
  • pregnancy/planned pregnancy.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00835900
Other Study ID Numbers  ICMJE I 136208
Pfizer IIR-GA30523
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Martin C Mahoney, MD, PhDRoswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date April 2017

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