Status:
COMPLETED
Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity
Lead Sponsor:
Medical University of South Carolina
Conditions:
Nicotine Dependence
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
This is a brief smoking cessation trial in women, comparing transdermal nicotine patch (TNP) versus varenicline.
Detailed Description
This component builds directly upon the results of the previously funded project in systematically investigating the impact of short-term ovarian hormone fluctuation on females as they try to quit smo...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00664755
Start Date
July 1 2007
End Date
December 1 2013
Last Update
May 24 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425