NCT01771627

Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

Pilot Study of Varenicline vs. Nicotine Patch Delivered by a Telephone Quitline to Promote Smoking Cessation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies varenicline or nicotine patch in promoting smoking cessation among current smokers. Varenicline or nicotine patch may help people stop smoking

Detailed description

PRIMARY OBJECTIVES: I. To determine if mail delivery of 12 weeks of varenicline results in improved smoking cessation outcomes relative to nicotine replacement therapy (NRT) in 300 smokers. II. To determine if delivery of varenicline is cost-effective as compared to nicotine patch. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo general smoking cessation counseling and receive varenicline orally (PO) twice daily (QD) on days 1-28. Courses repeat every 28 days for up to 12 weeks. ARM II: Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks. After completion of study treatment, patients are followed up at 4 months.

Conditions

• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	varenicline	Given PO
DRUG	nicotine patch

Timeline

• Start date: 2012-10-22
• Primary completion: 2014-09-28
• Completion: 2015-08-28
• First posted: 2013-01-18
• Last updated: 2020-09-28
• Results posted: 2020-09-28

Locations

1 site across 1 country: United States