Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers
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|ClinicalTrials.gov Identifier: NCT01771627|
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Disorder||Drug: varenicline Drug: nicotine patch||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Varenicline vs. Nicotine Patch Delivered by a Telephone Quitline to Promote Smoking Cessation|
|Actual Study Start Date :||October 22, 2012|
|Actual Primary Completion Date :||September 28, 2014|
|Actual Study Completion Date :||August 28, 2015|
Experimental: Arm I (varenicline)
Patients undergo general smoking cessation counseling and receive varenicline PO QD on days 1-28. Courses repeat every 28 days for up to 12 weeks.
Active Comparator: Arm II (nicotine patch)
Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.
Drug: nicotine patch
- Quit rate [ Time Frame: 4 months ]The quit rate at 4 months will be compared between the 2 groups, using a logistic regression analysis with a 2-side 95% confidence interval.
- Incremental cost per quit [ Time Frame: Up to 4 months ]Will be calculated by comparing the quit rates between the 2 conditions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771627
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Martin Mahoney||Roswell Park Cancer Institute|