Phase 2
N=140
Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00664755 ↗Enrolled (actual)
140
Serious AEs
0.7%
Results posted
May 2018
Primary outcome: Primary: End-of-treatment Abstinence — 25; 13 Participants — p=0.011
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- varenicline (Drug); transdermal nicotine patch (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Medical University of South Carolina
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY End-of-treatment Abstinence |
25; 13 | 0.011 sig |
Summary
This is a brief smoking cessation trial in women, comparing transdermal nicotine patch (TNP) versus varenicline.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00664755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.