Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
220 participants
INTERVENTIONAL
2008-03-31
2010-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Varenicline
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
Placebo
Placebo
same as Varenicline arm
Interventions
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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
Placebo
same as Varenicline arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Kidney disease
* Frequent nausea
* On certain medications for asthma and/or depression
* Another household member in study
18 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
University of Vermont Medical Center
OTHER
Responsible Party
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John Hughes
Professor
Principal Investigators
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John R Hughes, MD
Role: PRINCIPAL_INVESTIGATOR
University of Vermont
Locations
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Nebraska Medical Center
Omaha, Nebraska, United States
University of Vermont
Burlington, Vermont, United States
Countries
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References
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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.
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.
Other Identifiers
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IIR GA3051DO
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IIR GA3051DO
Identifier Type: -
Identifier Source: org_study_id