Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

NCT ID: NCT00664755

Last Updated: 2018-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2013-12-31

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 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.

Conditions

Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Varenicline

Participant randomized to receive active varenicline and placebo transdermal nicotine patch.

Group Type: EXPERIMENTAL

varenicline

Intervention Type: DRUG

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.

Transdermal Nicotine Patch

Participant randomized to receive active transdermal nicotine patch and placebo varenicline.

Group Type: ACTIVE_COMPARATOR

transdermal nicotine patch

Intervention Type: DEVICE

Weeks 0-3: 21mg patch

Transdermal nicotine patch is used for a duration of 3 weeks in this study.

Interventions

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.

Intervention Type: DRUG

transdermal nicotine patch

Weeks 0-3: 21mg patch

Transdermal nicotine patch is used for a duration of 3 weeks in this study.

Intervention Type: DEVICE

Other Intervention Names

Chantix; Nicoderm CQ

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Kevin Gray, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin Gray, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Michael E Saladin, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

Saladin ME, McClure EA, Baker NL, Carpenter MJ, Ramakrishnan V, Hartwell KJ, Gray KM. Increasing progesterone levels are associated with smoking abstinence among free-cycling women smokers who receive brief pharmacotherapy. Nicotine Tob Res. 2015 Apr;17(4):398-406. doi: 10.1093/ntr/ntu262.

Reference Type: DERIVED

PMID: 25762749 (View on PubMed)

Gray KM, McClure EA, Baker NL, Hartwell KJ, Carpenter MJ, Saladin ME. An exploratory short-term double-blind randomized trial of varenicline versus nicotine patch for smoking cessation in women. Addiction. 2015 Jun;110(6):1027-34. doi: 10.1111/add.12895. Epub 2015 Mar 29.

Reference Type: DERIVED

PMID: 25727442 (View on PubMed)

Other Identifiers

P50DA016511

Identifier Type: NIH

Identifier Source: org_study_id

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