Efficacy of Varenicline in Ambivalent Smokers

NCT00595868

Last updated date
Study Location
Nebraska Medical Center
Omaha, Nebraska, 68198, 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.
Tobacco Use Disorder, Tobacco Use Cessation, Nicotine Dependence
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

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


- Cannot be currently pregnant or breastfeeding


- Kidney disease


- Frequent nausea


- On certain medications for asthma and/or depression


- Another household member in study

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Tobacco Use Disorder, Tobacco Use Cessation, Nicotine DependenceEfficacy of Varenicline in Ambivalent Smokers
NCT00595868
  1. Omaha, Nebraska
  2. Burlington, Vermont
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2008)
220
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, MDUniversity 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