Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity
|ClinicalTrials.gov Identifier: NCT00664755|
Recruitment Status : Completed
First Posted : April 23, 2008
Results First Posted : May 24, 2018
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Drug: varenicline Device: transdermal nicotine patch||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Participant randomized to receive active varenicline and placebo transdermal nicotine patch.
Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID
Varenicline is taken for a duration of 4 weeks in this study.
Other Name: Chantix
Active Comparator: Transdermal Nicotine Patch
Participant randomized to receive active transdermal nicotine patch and placebo varenicline.
Device: transdermal nicotine patch
Weeks 0-3: 21mg patch
Transdermal nicotine patch is used for a duration of 3 weeks in this study.
Other Name: Nicoderm CQ
- End-of-treatment Abstinence [ Time Frame: 2 weeks ]Carbon monoxide (≤10 parts per million) verified abstinence during the last two weeks of treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664755
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Kevin Gray, MD||Medical University of South Carolina|
|Principal Investigator:||Michael E Saladin, PhD||Medical University of South Carolina|