Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

April 23, 2018 updated by: Kevin Gray, MD, Medical University of South Carolina
This is a brief smoking cessation trial in women, comparing transdermal nicotine patch (TNP) versus varenicline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Varenicline
Participant randomized to receive active varenicline and placebo transdermal nicotine patch.
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.

Other Names:
  • Chantix
Active Comparator: Transdermal Nicotine Patch
Participant randomized to receive active transdermal nicotine patch and placebo varenicline.
Device: transdermal nicotine patch

Weeks 0-3: 21mg patch

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

Other Names:
  • Nicoderm CQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
End-of-treatment Abstinence
Time Frame: 2 weeks
Carbon monoxide (≤10 parts per million) verified abstinence during the last two weeks of treatment
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Michael E Saladin, PhD, Medical University of South Carolina
  • Principal Investigator: Kevin Gray, MD, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 21, 2008

First Submitted That Met QC Criteria

April 22, 2008

First Posted (Estimate)

April 23, 2008

Study Record Updates

Last Update Posted (Actual)

May 24, 2018

Last Update Submitted That Met QC Criteria

April 23, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P50DA016511 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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