Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

NCT00664755 | Completed Phase 2 Results DMC

• 1 other identifier: P50DA016511
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nicotine Dependence

Keywords

Menstrual Cycle effects; Cue Reactivity; Smoking Cessation; Impulsivity

Outcome Measures

Primary Outcomes (1)

• End-of-treatment Abstinence

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

  2 weeks

Study Arms (2)

Varenicline

EXPERIMENTAL

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

Drug: varenicline

Transdermal Nicotine Patch

ACTIVE COMPARATOR

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

Device: transdermal nicotine patch

Interventions

varenicline DRUG

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.

Also known as: Chantix

Varenicline

transdermal nicotine patch DEVICE

Weeks 0-3: 21mg patch Transdermal nicotine patch is used for a duration of 3 weeks in this study.

Also known as: Nicoderm CQ

Transdermal Nicotine Patch

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

• 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.

  PMID: 25762749 DERIVED

• 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.

  PMID: 25727442 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation; Impulsive Behavior

Interventions

Varenicline; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Therapeutics

Results Point of Contact

• Title: Kevin M. Gray, M.D.
• Organization: Medical University of South Carolina

graykm@musc.edu

843-792-6330

Study Officials

• Kevin Gray, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Michael E Saladin, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 23, 2008
• Study Start: July 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 24, 2018
• Results First Posted: May 24, 2018

Record last verified: 2018-04

Locations

US (1)