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Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

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ClinicalTrials.gov Identifier: NCT00664755
Recruitment Status : Completed
First Posted : April 23, 2008
Results First Posted : May 24, 2018
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Kevin Gray, MD, Medical University of South Carolina

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

Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: varenicline Device: transdermal nicotine patch Phase 2

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  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity
Study Start Date : July 2007
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Nicoderm CQ




Primary Outcome Measures :
  1. End-of-treatment Abstinence [ Time Frame: 2 weeks ]
    Carbon monoxide (≤10 parts per million) verified abstinence during the last two weeks of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664755


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kevin Gray, MD, Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00664755     History of Changes
Other Study ID Numbers: P50DA016511 ( U.S. NIH Grant/Contract )
First Posted: April 23, 2008    Key Record Dates
Results First Posted: May 24, 2018
Last Update Posted: May 24, 2018
Last Verified: April 2018

Keywords provided by Kevin Gray, MD, 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
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action