Smoking, Sex Hormones, and Pregnancy

Smoking, Sex Hormones, and Pregnancy

Sponsors

Lead Sponsor: University of Minnesota

Source University of Minnesota
Brief Summary

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

Detailed Description

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.

Overall Status Completed
Start Date December 2012
Completion Date June 2017
Primary Completion Date June 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Minnesota Nicotine Withdrawal Scale Day 0 and Day 6
Secondary Outcome
Measure Time Frame
Change in Smoking Urges Day 0 and Day 6
Change in Modified Cigarette Evaluation Questionnaire Responses Day 0 and Day 6
Change in Positive and Negative Affect Scale Day 0 and Day 6
Change in Cohen Perceived Stress Scale Day 0 and Day 6
Change in Depression (Center for Epidemiologic Studies) Day 0 and Day 6
Change in Leisure Time Exercise Questionnaire Responses Day 0 and Day 6
Monitoring Subjective State Scale Responses Day 5
Salivary cortisol level Day 5
Enrollment 204
Condition
Intervention

Intervention Type: Drug

Intervention Name: Low dose progesterone

Description: The "low" dose progesterone is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM).

Arm Group Label: Sample 2 - Oral Contraceptive Users

Intervention Type: Drug

Intervention Name: High dose progesterone

Description: The "high" progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM).

Arm Group Label: Sample 2 - Oral Contraceptive Users

Eligibility

Criteria:

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.

Gender: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Sharon S. Allen, M.D. Principal Investigator Masonic Cancer Center, University of Minnesota
Location
Facility: Masonic Cancer Center, University of Minnesota
Location Countries

United States

Verification Date

June 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Sample 1 - Pregnant Women

Type: No Intervention

Description: Females 18-35 years old, in stable physical/mental health with confirmed pregnancy, 16-36 weeks gestation

Label: Sample 2 - Oral Contraceptive Users

Type: Experimental

Description: Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment.

Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov