Smoking, Stress & Allopregnanolone Response

Effect of Smoking on Stress-Induced Allopregnanolone Response in Women by Menstrual Phase

This study aims to characterize the effect of smoking on stress-induced allopregnanolone (ALLO) response in women by menstrual phase. The investigators hypothesize that women who smoke will have a blunted ALLO response to stress.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: F phase lab session; Behavioral: L phase lab session

Detailed Description

Cigarette smoking persists as the leading cause of preventable morbidity and mortality. Thus, finding ways to maximize quitting behavior is critical. Women have a more difficult time achieving smoking abstinence than men. The risk for smoking relapse appears to vary by menstrual phase such that the follicular phase is associated with greater risk compared to the luteal phase. Women are also more likely to smoke in response to stressful stimuli than men. Allopregnanolone (ALLO) is a stress-reducing neuroactive steroid that is primarily metabolized from the sex hormone progesterone and, therefore, varies by menstrual phase in women. Recent preclinical literature has indicated that ALLO may protect against drug abuse behaviors. Unfortunately, ALLO remains largely unexplored in clinical samples containing women.

In this study we aim to characterize the effect of smoking on stress-induced ALLO response in women by menstrual phase. To achieve this goal, we will recruit a sample of premenopausal women who smoke (n=30) and do not smoke (n=30) to participate in a controlled cross-over study. All participants will complete two four-hour lab sessions timed to occur in the Follicular (F; low ALLO) and Luteal (L; high ALLO) menstrual phases. Each lab session will contain an acute stressor along with a timed series of assessments including blood samples (for ALLO measurement) and self-report of mood and perceived stress.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Tobacco Research Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women between the ages of 18 and 40 who either smoke or do not smoke.

Description

Inclusion Criteria:

• Female between the ages of 18-40 years old
• Stable physical/mental health,
• Self-report of regular menstrual cycles,
• Self-report of either smoking either current or never smoking,
• English fluency,
• Ability to provide informed consent

Exclusion Criteria:

• Self-report of current use of illicit drugs, other tobacco products, nicotine, or smoking cessation medications,
• Current or recent pregnancy or breastfeeding,
• Current or recent use of exogenous hormones (including birth control pills),
• Current or recent use of psychotropic medications.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
F Phase Lab session; Potential participants will complete an interview over the phone, followed by an in clinic office visit, to assess eligibility. Those who meet eligibility criteria will be invited to attend two four-hour lab sessions. Lab sessions will occur in the F (F phase lab session) and L phases (L phase lab session) of menses. In this arm, the F phase lab session will be first. Followed by the L phase lab session.	Behavioral: F phase lab session; F phase sessions will occur three to seven days post the onset of menses. It will include blood draws, an acute stressor and completion of questionnaires.; Behavioral: L phase lab session; L phase sessions will occur six to ten days prior to the onset of the next expected menses. It will include blood draws, an acute stressor and completion of questionnaires.
L Phase Lab Session; Potential participants will complete an interview over the phone, followed by an in clinic office visit, to assess eligibility. Those who meet eligibility criteria will be invited to attend two four-hour lab sessions. Lab sessions will occur in the F (F phase lab session) and L phases (L phase lab session) of menses. In this arm, the L phase lab session will be first. Followed by the F phase lab session.	Behavioral: F phase lab session; F phase sessions will occur three to seven days post the onset of menses. It will include blood draws, an acute stressor and completion of questionnaires.; Behavioral: L phase lab session; L phase sessions will occur six to ten days prior to the onset of the next expected menses. It will include blood draws, an acute stressor and completion of questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in allopregnanolone levels	The change in ALLO after delivery of the acute stressor will be analyzed.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mood	We will analyze ALLO levels and mood to see if there is an association between the two.	6 weeks
Change in stress level	We will analyze ALLO levels and perceived stress level to see if there is an association and whether stress changes as ALLO levels change.	6 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: March 12, 2014
• First Submitted That Met QC Criteria: March 13, 2014
• First Posted (ESTIMATE): March 14, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): November 30, 2015
• Last Update Submitted That Met QC Criteria: November 25, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: smoking cessation; allopregnanolone; smoking abstinence
• Other Study ID Numbers: 2013NTLS120