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Sponsored by: |
Medical University of South Carolina |
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Information provided by: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT00664755 |
This study is looking to see if female smokers who quit within the luteal phase of their menstrual cycle will have shorter relapse latency than female smokers with a quit date in the follicular phase.
In addition, this study is looking at the relationship between subjective and physiological responses to smoking cues in a human laboratory paradigm.
Condition | Intervention | Phase |
---|---|---|
Nicotine Dependence |
Drug: varenicline Device: transdermal nicotine patch |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity |
Estimated Enrollment: | 224 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | July 2012 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Quit date in follicular phase receiving active varenicline
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Drug: varenicline
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 12 weeks. |
2: Active Comparator
Quit date in follicular receiving active transdermal nicotine patch
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Device: transdermal nicotine patch
Weeks 0-12: 21mg patch Weeks 13-14: 14mg patch Week 15: 7mg patch
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3: Experimental
Quit date in luteal phase receiving active varenicline
|
Drug: varenicline
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 12 weeks. |
4: Active Comparator
Quit date in luteal phase receiving active transdermal nicotine patch
|
Device: transdermal nicotine patch
Weeks 0-12: 21mg patch Weeks 13-14: 14mg patch Week 15: 7mg patch
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, South Carolina | |
Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29403 | |
Contact: Ashley McCullough, BS 843-792-5842 mccullos@musc.edu | |
Contact: Christine Horne, BS 843-792-5807 hornechr@musc.edu | |
Principal Investigator: Himanshu P Upadhyaya, MBBS, MS |
Principal Investigator: | Himanshu P Upadhyaya, MBBS, MS | Medical University of South Carolina |
Responsible Party: | Medical University of South Carolina ( Himanshu P. Upadhyaya, MBBS, MS ) |
Study ID Numbers: | P50DA016511 |
Study First Received: | April 21, 2008 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00664755 |
Health Authority: | United States: Institutional Review Board |
Menstrual Cycle effects Cue Reactivity Smoking Cessation Impulsivity |
Nicotine polacrilex Smoking Nicotine Mental Disorders |
Tobacco Use Disorder Substance-Related Disorders Disorders of Environmental Origin |