Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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): 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|