NCT00595868

Efficacy of Varenicline in Ambivalent Smokers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: University of Vermont Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tobacco Use Disorder
• Tobacco Use Cessation
• Nicotine Dependence

Interventions

Type	Name	Description
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
DRUG	Placebo	same as Varenicline arm

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-01-16
• Last updated: 2011-12-02
• Results posted: 2011-11-22

Locations

2 sites across 1 country: United States