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Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity
This study is currently recruiting participants.
Verified by Medical University of South Carolina, April 2008
Sponsored by: Medical University of South Carolina
Information provided by: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00664755
  Purpose

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

MedlinePlus related topics: Menstruation Quitting Smoking Smoking
Drug Information available for: Varenicline Nicotine polacrilex Nicotine tartrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title: Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Time to relapse. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

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
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
Device: transdermal nicotine patch
Weeks 0-12: 21mg patch Weeks 13-14: 14mg patch Week 15: 7mg patch
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-45. Individuals over the age of 45 will not be included as we are examining the effects of menstrual cycle and ovarian hormones.
  • Daily smokers who smoke at least 10 cigarettes per day for at least past 6 months.
  • Post menarche and pre menopausal
  • Regular menstrual cycle between 25 and 35 days
  • At least three months post delivery and breast feeding
  • Desire to quit smoking and willingness to participate in a research study.
  • Women with a history of depression (but not current MDE) and current PMDD will be included. Excluding women with these diagnoses would have a major impact on feasibility, but because both disorders might impact treatment outcome, individuals will be stratified across randomization groups.

Exclusion Criteria:

  • Any unstable major axis I psychiatric disorder in the past month
  • Current substance use disorders other than nicotine and caffeine use, in the past 30 days.
  • Any medication that may interfere with psychophysiological monitoring
  • Unstable medical or serious medical condition in the past 6 months
  • Hypersensitivity to varenicline or TNP
  • Use of other tobacco products
  • Use of other medications with smoking cessation efficacy within 30 days prior to enrollment
  • BMI less than 15 since this could alter hormone levels that affect menstrual phase
  • Pregnancy
  • Breast feeding
  • Status post hysterectomy
  • Birth control or HRT medication that would effect the menstrual cycle. Currently available oral contraceptives contain either a combination of a synthetic estrogen and synthetic progestin, or a progestin alone. Estrogen and/or progestin inhibit ovulation and alter cervical mucus and the endometrium by suppressing the production of follicle-stimulating hormone and the luteinizing hormone surge (Bucci & Carson, 1997)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00664755

Locations
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            
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Himanshu P Upadhyaya, MBBS, MS Medical University of South Carolina
  More Information

Related Info  This link exits the ClinicalTrials.gov site

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

Keywords provided by Medical University of South Carolina:
Menstrual Cycle effects
Cue Reactivity
Smoking Cessation
Impulsivity

Study placed in the following topic categories:
Nicotine polacrilex
Smoking
Nicotine
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 16, 2009