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Phase 2 N=140 Randomized Single-blind Treatment

Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

Nicotine Dependence

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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

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