Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

Nicotine Dependence Clinical Trial

Official title:

Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00664755
• Other study ID #: P50DA016511
• Status: Completed
• Phase: Phase 2
• Start date: July 2007
• Est. completion date: December 2013

Study information

• Verified date: April 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a brief smoking cessation trial in women, comparing transdermal nicotine patch (TNP) versus varenicline.

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 smoking with the aid of either transdermal nicotine patch (TNP) or varenicline. Each participant will receive a standardized impulsivity evaluation and a laboratory-based cue reactivity assessment before the initiation of smoking cessation. Progesterone and estrogen levels will be measured at each of nine visits, thereby providing an index of reproductive hormone variation over the course of each participant's quit attempt. This novel approach of integrating a human laboratory cue reactivity paradigm directly with a treatment outcome study will permit us to assess whether or not smoking cue reactivity has predictive utility with respect to cessation outcome. Subjects will be randomized to receive one of two active pharmacotherapeutic interventions for smoking cessation: TNP vs. varenicline in a randomized, single-blind, double dummy design. While TNP has demonstrated modest efficacy in improving smoking cessation outcomes, there is some evidence that its efficacy may be more robust in men as compared to women. This project will provide important information about a) the impact of ovarian hormone levels on smoking cessation outcomes, b) the relationship between smoking cue reactivity and smoking cessation, and c) comparison between a new pharmacotherapeutic agent and TNP in women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

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 4 weeks in this study.

Device:
• transdermal nicotine patch
Weeks 0-3: 21mg patch Transdermal nicotine patch is used for a duration of 3 weeks in this study.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End-of-treatment Abstinence	Carbon monoxide (=10 parts per million) verified abstinence during the last two weeks of treatment	2 weeks