Smoking, Sex Hormones, and Pregnancy
Sample 1 will consist of pregnant women and Sample 2 will be oral contraceptive users.
Sample 2 will be testing "low" and "high" dose levels of exogenous progesterone with a
consistent dose of exogenous estrogen. All participants will complete identical 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 three-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.
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Change in Minnesota Nicotine Withdrawal Scale
Measured an average of three times a day for six days -Participants rate their nicotine withdrawal symptoms on eight-items on a scale of '0' (not present) to '4' (severe) resulting in summary scores overall withdrawal and craving.
Day 0 and Day 6
Sharon S. Allen, M.D.
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|