Smoking, Sex Hormones, and Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01811225
First received: February 21, 2013
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
The Association Between Progesterone Levels and Smoking-related Symptomatology and Nicotine Cravings.
Drug: Low dose progesterone
Drug: High dose progesterone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Smoking, Sex Hormones, and Pregnancy

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Change in Minnesota Nicotine Withdrawal Scale [ Time Frame: Day 0 and Day 6 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Smoking Urges [ Time Frame: Day 0 and Day 6 ] [ Designated as safety issue: No ]
    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). Two factors are obtained: 'Factor 1' is a measure of primary intention and desire to smoke and 'Factor 2' is a desire to smoke in anticipation of relief from negative affect.

  • Change in Modified Cigarette Evaluation Questionnaire Responses [ Time Frame: Day 0 and Day 6 ] [ Designated as safety issue: No ]
    Modified Cigarette Evaluation Questionnaire (mCEQ): This 12-item questionnaire uses a seven-point Likert-type scale to assess the reinforcing effects of smoking resulting in five domains including smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations and craving reduction.

  • Change in Positive and Negative Affect Scale [ Time Frame: Day 0 and Day 6 ] [ Designated as safety issue: No ]
    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.

  • Change in Cohen Perceived Stress Scale [ Time Frame: Day 0 and Day 6 ] [ Designated as safety issue: No ]
    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).

  • Change in Depression (Center for Epidemiologic Studies) [ Time Frame: Day 0 and Day 6 ] [ Designated as safety issue: No ]
    Center for Epidemiologic Studies - Depression (CES-D): This form contains ten-items to assess symptoms typically associated with depression. The items are ranked using a four-point Likert-type scale. It has high levels of sensitivity and specificity. 50-51 We have opted to use this item rather pregnancy-specific item to ensure that all participants had comparable data.

  • Change in Leisure Time Exercise Questionnaire Responses [ Time Frame: Day 0 and Day 6 ] [ Designated as safety issue: No ]
    Leisure Time Exercise Questionnaire (LTEQ): This questionnaire has four-items to assess strenuous, moderate and mild exercise completed during leisure time and has high reliability (r=0.83, 0.85).

  • Monitoring Subjective State Scale Responses [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    Monitoring Subjective State Scale (mSSS, Day 5 only): This form is identical to the Subjective State Scale (SSS) except it also includes variables to assess possible confounders such as coffee consumption. Participants will be asked to mark each rating scale at the point that best describes how they felt over the past 30 minutes.

  • Salivary cortisol level [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    Salivary Cortisol (Day 5 only): Five saliva samples over the course of the day given that cortisol, a physiological measure of stress released by the hypothalamic-pituitary adrenal axis (HPAA), has a clear diurnal variation. Its peak activity occurs about 8:00 am in the normal sleeper, followed by steady decline until noon. The lowest activity occurs around 8:00 pm. The frequent sampling in the morning will be used to assess free cortisol responses to awakening. Awakening cortisol increase is considered a promising marker of adrenocortical functional status.


Estimated Enrollment: 204
Study Start Date: December 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Sample 1 - Pregnant Women
Females 18-35 years old, in stable physical/mental health with confirmed pregnancy, 16-36 weeks gestation
Experimental: Sample 2 - Oral Contraceptive Users
Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment.
Drug: Low dose progesterone
The "low" dose progesterone is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM).
Drug: High dose progesterone
The "high" progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01811225

Contacts
Contact: Nicole L Tosun, M.S. 612-624-5350 tosun004@umn.edu

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Nicole L. Tosun, M.S.    612-624-5350    tosun004@umn.edu   
Principal Investigator: Sharon S. Allen, M.D.         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Sharon S. Allen, M.D. Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01811225     History of Changes
Other Study ID Numbers: 2012NTLS018
Study First Received: February 21, 2013
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Women
Pregnancy
Smoking

Additional relevant MeSH terms:
Contraceptives, Oral
Hormones
Progesterone
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hormones, Hormone Substitutes, and Hormone Antagonists
Progestins

ClinicalTrials.gov processed this record on August 28, 2014