Smoking, Sex Hormones, and Pregnancy
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
The Association Between Progesterone Levels and Smoking-related Symptomatology and Nicotine Cravings.
Drug: Low dose progesterone
Drug: High dose progesterone
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Smoking, Sex Hormones, and Pregnancy|
- 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.
- 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.
|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)|
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01811225
|Contact: Nicole L Tosun, M.S.||firstname.lastname@example.org|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Nicole L. Tosun, M.S. 612-624-5350 email@example.com|
|Principal Investigator: Sharon S. Allen, M.D.|
|Principal Investigator:||Sharon S. Allen, M.D.||Masonic Cancer Center, University of Minnesota|