Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

• 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: Medical University of South Carolina
• Information provided by (Responsible Party): Kevin Gray, MD, Medical University of South Carolina

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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)

Contacts and Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Kevin Gray, MD, Principal Investigator, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT00664755
• Other Study ID Numbers: P50DA016511 ( U.S. NIH Grant/Contract )
• First Posted: April 23, 2008
• 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