Nicotine Dependence
Conditions
Keywords
Menstrual Cycle effects, Cue Reactivity, Smoking Cessation, Impulsivity
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.
Interventions
DRUGvarenicline
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.
DEVICEtransdermal nicotine patch
Weeks 0-3: 21mg patch Transdermal nicotine patch is used for a duration of 3 weeks in this study.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End-of-treatment Abstinence | 2 weeks | Carbon monoxide (≤10 parts per million) verified abstinence during the last two weeks of treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenicline Participant randomized to receive active varenicline and placebo transdermal nicotine patch.
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. | 67 |
| Transdermal Nicotine Patch Participant randomized to receive active transdermal nicotine patch and placebo varenicline.
transdermal nicotine patch: Weeks 0-3: 21mg patch
Transdermal nicotine patch is used for a duration of 3 weeks in this study. | 73 |
| Total | 140 |
Baseline characteristics
| Characteristic | Transdermal Nicotine Patch | Total | Varenicline |
|---|---|---|---|
| Age, Continuous | 33.0 years STANDARD_DEVIATION 7.4 | 31.9 years STANDARD_DEVIATION 7.7 | 30.7 years STANDARD_DEVIATION 7.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 30 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 57 Participants | 110 Participants | 53 Participants |
| Sex: Female, Male Female | 73 Participants | 140 Participants | 67 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 73 |
| other Total, other adverse events | 67 / 67 | 73 / 73 |
| serious Total, serious adverse events | 0 / 67 | 1 / 73 |
Outcome results
Primary
End-of-treatment Abstinence
Carbon monoxide (≤10 parts per million) verified abstinence during the last two weeks of treatment
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Varenicline | End-of-treatment Abstinence | 25 Participants |
| Transdermal Nicotine Patch | End-of-treatment Abstinence | 13 Participants |
p-value: 0.01195% CI: [1.17, 6.59]Regression, Logistic