Smoking, Sex Hormones, and Pregnancy
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 6/30/2017 |
| Start Date: | December 2012 |
| End Date: | June 2017 |
Using two clinical models - pregnancy (Sample 1) and oral contraceptives (OC; Sample 2) - we
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
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
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.
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.
Inclusion Criteria:
- Sample 1
- females 18-35 years old,
- has established prenatal care,
- currently pregnant,
- English fluency, and able to provide informed consent.
- Sample 2
- females 18-35 years old,
- currently taking oral contraceptives,
- English fluency, and able to provide informed consent.
Exclusion Criteria:
- Sample 1
- < 18 or > 35 years of age,
- or pregnancy complications.
- Sample 2
- < 18 or > 35 years of age,
- use of progestin only contraceptive.
We found this trial at
1
site
425 E River Pkwy # 754
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
612-624-2620
Principal Investigator: Sharon S. Allen, M.D.
Phone: 612-624-5377
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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