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Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
varenicline
transdermal nicotine patch
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Menstrual Cycle effects, Cue Reactivity, Smoking Cessation, Impulsivity

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Varenicline

Transdermal Nicotine Patch

Arm Description

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

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

Outcomes

Primary Outcome Measures

End-of-treatment Abstinence
Carbon monoxide (≤10 parts per million) verified abstinence during the last two weeks of treatment

Secondary Outcome Measures

Full Information

First Posted
April 21, 2008
Last Updated
April 23, 2018
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT00664755
Brief Title
Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity
Official Title
Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
Menstrual Cycle effects, Cue Reactivity, Smoking Cessation, Impulsivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Varenicline
Arm Type
Experimental
Arm Description
Participant randomized to receive active varenicline and placebo transdermal nicotine patch.
Arm Title
Transdermal Nicotine Patch
Arm Type
Active Comparator
Arm Description
Participant randomized to receive active transdermal nicotine patch and placebo varenicline.
Intervention Type
Drug
Intervention Name(s)
varenicline
Other Intervention Name(s)
Chantix
Intervention Description
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
Device
Intervention Name(s)
transdermal nicotine patch
Other Intervention Name(s)
Nicoderm CQ
Intervention Description
Weeks 0-3: 21mg patch Transdermal nicotine patch is used for a duration of 3 weeks in this study.
Primary Outcome Measure Information:
Title
End-of-treatment Abstinence
Description
Carbon monoxide (≤10 parts per million) verified abstinence during the last two weeks of treatment
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Gray, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael E Saladin, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25762749
Citation
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.
Results Reference
derived
PubMed Identifier
25727442
Citation
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.
Results Reference
derived

Learn more about this trial

Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

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