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Smoking, Sex Hormones, and Pregnancy


N/A
18 Years
35 Years
Open (Enrolling)
Female
The Association Between Progesterone Levels and Smoking-related Symptomatology and Nicotine Cravings.

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Change in Minnesota Nicotine Withdrawal Scale

Outcome Description:

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.

Outcome Time Frame:

Day 0 and Day 6

Safety Issue:

No

Principal Investigator

Sharon S. Allen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

2012NTLS018

NCT ID:

NCT01811225

Start Date:

December 2012

Completion Date:

March 2017

Related Keywords:

  • The Association Between Progesterone Levels and Smoking-related Symptomatology and Nicotine Cravings.
  • Women
  • Pregnancy
  • Smoking
  • Smoking

Name

Location
Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455