Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Medical University of South Carolina.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00664755
First received: April 21, 2008
Last updated: August 4, 2011
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Nicotine Dependence
Drug: varenicline
Device: transdermal nicotine patch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Time to relapse. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 214
Study Start Date: July 2007
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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 Name: Chantix
Active Comparator: 2
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 Name: Nicoderm CQ

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664755

Contacts
Contact: Ashley McCullough, MSW (843) 792-5842 mccullos@musc.edu
Contact: Jessica H. Olsen, BS (843) 792-4009 olsenj@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Ashley McCullough, MSW    843-792-5842    mccullos@musc.edu   
Contact: Jessica H. Olsen, BS    (843) 792-4009    olsenj@musc.edu   
Principal Investigator: Kevin Gray, MD         
Principal Investigator: Michael Saladin, PhD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Kevin Gray, MD Medical University of South Carolina
Principal Investigator: Michael E Saladin, PhD Medical University of South Carolina
  More Information

Additional Information:
No publications provided

Responsible Party: Kevin Gray, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00664755     History of Changes
Other Study ID Numbers: P50DA016511
Study First Received: April 21, 2008
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Menstrual Cycle effects
Cue Reactivity
Smoking Cessation
Impulsivity

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014