Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity - Full Text View

Sponsored by:	Medical University of South Carolina
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00664755

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 IV

MedlinePlus related topics: Menstruation Quitting Smoking Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex Varenicline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment
Official Title:	Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

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
1: Experimental 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.
2: Active Comparator 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.

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

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

Locations

United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29403
Contact: Ashley McCullough, BS 843-792-5842 mccullos@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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical University of South Carolina ( Kevin Gray, MD )
Study ID Numbers:	P50DA016511
Study First Received:	April 21, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00664755 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:

Menstrual Cycle effects
Cue Reactivity
Smoking Cessation
Impulsivity

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Neurotransmitter Agents
Nicotine
Mental Disorders
Nicotinic Agonists

Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin
Peripheral Nervous System Agents
Cholinergic Agents
Varenicline

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Tobacco Use Disorder
Nicotinic Agonists
Physiological Effects of Drugs
Disorders of Environmental Origin
Cholinergic Agents

Pharmacologic Actions
Mental Disorders
Nicotine
Autonomic Agents
Substance-Related Disorders
Ganglionic Stimulants
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009