The investigators aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology during ad libitum smoking and (2) determine the association between Prog, Allo, and E2/P with the changes in smoking-related symptomatology and response to nicotine following overnight abstinence
The sample population will consist of oral contraceptive users, both "low" and "high" dose levels of exogenous progesterone with a consistent dose of exogenous estrogen. Participants will complete data collection procedures including providing saliva (cortisol to measure stress), urine (cotinine and 3-Hydroxycotinine to measure nicotine exposure), and blood (progesterone, allopregnanolone, and estradiol) samples, as well as ecological momentary assessments (EMA) daily for seven-days. Participants will also complete a 3-hour smoking topography lab session after overnight abstinence and a 4.5-hour nicotine nasal spray lab session after a 14-hour abstinence. These sessions will contain a nicotine challenge via smoking a cigarette or nasal spray with timed-series physiological, subjective, and behavioral responses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
95
The "low" progesterone dose is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM).
The "high" progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM).
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Change in Smoking Urges
Questionnaire on Smoking Urges-Brief (QSU-Brief): This ten-item version of the original form (QSU) was developed by Tiffany and Drobes and has an excellent level of reliability (α = .97). Total QSU-Brief. Scores can average between 1-7. A higher scores means more urges.
Time frame: after overnight abstinence on day 8
Change in Positive and Negative Affect Scale Following Overnight Abstinence
Positive and Negative Affect Scale (PANAS): Participants rate 20 words associated with positive or negative affect using a five-point Likert-type scale. This scale has been shown to have high internal consistency. Positive PANAS scores can range from 10-50. A higher score means greater positive affect. Negative PANAS score can range from 10-50. A higher score means greater negative affect.
Time frame: after overnight abstinence on day 8
Change in Cohen Perceived Stress Scale
Cohen Perceived Stress Scale (PSS): This ten-item questionnaire has been validated in a variety of populations including pregnant and postpartum women. It uses five-items to assess ten questions resulting in two factors negative feelings and inability to handle stress. It has high internal reliability (alpha = 0.75). Score range from 0-56. A higher score means more perceived stress.
Time frame: after overnight abstinence on day 8
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