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Trial record 1 of 1 for:    NCT00595868
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Efficacy of Varenicline in Ambivalent Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00595868
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : November 22, 2011
Last Update Posted : December 2, 2011
Information provided by (Responsible Party):
John Hughes, University of Vermont Medical Center

Tracking Information
First Submitted Date  ICMJE January 4, 2008
First Posted Date  ICMJE January 16, 2008
Results First Submitted Date  ICMJE September 7, 2011
Results First Posted Date  ICMJE November 22, 2011
Last Update Posted Date December 2, 2011
Study Start Date  ICMJE March 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2011)
Number of Participants With a Quit Attempt [ Time Frame: 6 months ]
A quit attempt was defined as a self-reported attempt to quit smoking on a given day reported on a Time Line Follow Back (TLFB) obtained at each visit for the first 2 months and via monthly phone calls during months 3-6. The TLFB collected information for each day since the previous visit/call on number of cigarettes smoked that day, whether medication (varenicline or placebo) was used that day, and whether a quit attempt occured that day.
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
Among ambivalent smokers, use of Varenicline for 2 months will increase the incidence of a quit attempt more than use of placebo. Self-report will be verified with CO via breath. [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2011)
7 Day Point Prevalent Abstinence Verified by Breath Carbon Monoxide of Less Than 10 Parts Per Million [ Time Frame: 6 months ]
7 day point prevalent abstinence 6 months after enrolling in the study was determined by two steps: (1) A report of no days of smoking for the 7 days prior to the 6 month on the Time Line Follow Back obtained at a telephone call 6 months after enrollment; (2) Those who reported no smoking for the prior 7 days came to our lab for breath carbon monoxide (CO) measurement to confirm abstinence. Breath CO had to be less than 10 parts per million for the participant to be classified as abstinent.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Efficacy of Varenicline in Ambivalent Smokers
Official Title  ICMJE Efficacy of Varenicline in Ambivalent Smokers
Brief Summary The purpose of this study is to test whether Varenicline can help ambivalent smokers (those who are interested in quitting at some point in the future but have no current plans to quit) to reduce their smoking and eventually quit.
Detailed Description

Many smokers want to quit but have no plans to do so in the near future. Recent studies indicate that helping such smokers reduce the number of cigarettes they smoke each day, try medications to see that medications can help control their cravings, can make it easier for them to try to quit. This study tests whether a new medication (generic name = varenicline; brand name = Chantix) can help smokers in these ways.

The investigators will recruit 110 smokers in Vermont and 110 in Omaha, Nebraska, all of whom are interested in quitting some time in the future but have no current plans to quit. These smokers will be assigned by chance to receive either varenicline or a placebo. Neither the participants nor the scientists will know what the participants are receiving. Varenicline is a medication approved for smoking cessation in smokers who already have decided to quit. Varenicline both acts like nicotine to relieve craving and withdrawal when smokers try to quit and, importantly, also blocks the effects of nicotine from cigarettes. When smokers take varenicline and smoke, their cigarettes seem weaker and less beneficial. The investigators believe that making cigarettes less pleasing will make it easier for smokers to reduce, give them more control over their smoking, reduce their addiction to cigarettes, and make it easier for them to quit. After screening and giving consent, smokers will attend a first session to receive medication or placebo and to be instructed in how to use it to reduce their smoking. Smokers will be told they should use the medicine for at least 2 weeks and can use the medication for up to 2 months and, if they try to quit, they can receive an additional 3 months of medication after their quit date. Participants will be seen again at 2 weeks, 4 weeks and 2 months for brief help in reducing. After the first 2 months , they will be contacted by phone monthly for four more months. If participants are abstinent at 6 months they will be asked to return to provide a breath sample to verify abstinence. Participants will be asked to complete either written surveys or answer phone interviews and provide breath tests for which they will be reimbursed. The investigators will test, whether after 6 months, more smokers in the varenicline group tried to quit than in the placebo group.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Tobacco Use Disorder
  • Tobacco Use Cessation
  • Nicotine Dependence
Intervention  ICMJE
  • Drug: Varenicline
    0.5 milligrams two times per day for 3 days, then 1.0 milligrams two times per day for an addition 11 days - 2 months
    Other Name: Chantix
  • Drug: Placebo
    same as Varenicline arm
Study Arms  ICMJE
  • Experimental: Varenicline
    Intervention: Drug: Varenicline
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Hughes JR, Rennard SI, Fingar JR, Talbot SK, Callas PW, Fagerstrom KO. Efficacy of varenicline to prompt quit attempts in smokers not currently trying to quit: a randomized placebo-controlled trial. Nicotine Tob Res. 2011 Oct;13(10):955-64. doi: 10.1093/ntr/ntr103. Epub 2011 Jun 7.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2008)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years old
  • Able to get to research lab in Burlington, Vermont or Omaha, Nebraska
  • Daily smoker
  • Smoke at least 8 cigarettes per day
  • No reduction in smoking in last 30 days
  • No intention to quit in the next 30 days
  • Never used Varenicline before
  • Not currently using smoking cessation medications or nicotine replacement therapy
  • Willing to use Varenicline for at least 2 weeks
  • Fluent in English

Exclusion Criteria:

  • Cannot be currently pregnant or breastfeeding
  • Kidney disease
  • Frequent nausea
  • On certain medications for asthma and/or depression
  • Another household member in study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT00595868
Other Study ID Numbers  ICMJE IIR GA3051DO
IIR GA3051DO ( Other Grant/Funding Number: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Hughes, University of Vermont Medical Center
Study Sponsor  ICMJE University of Vermont Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: John R Hughes, MD University of Vermont
PRS Account University of Vermont Medical Center
Verification Date November 2011

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