Clinical trial NCT00664755: Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity
Official title: Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nicotine Dependence
Keywords: Menstrual Cycle effects
Cue Reactivity
Smoking Cessation
Impulsivity
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2008-04-23
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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)

Primary outcomes:
measure: End-of-treatment Abstinence
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Kevin Gray, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Michael E Saladin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.