Smoking, Stress & Allopregnanolone Response

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: F phase lab session; Behavioral: L phase lab session

• Registration Number: NCT02087800
• Lead Sponsor: University of Minnesota

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-14
• Study Start: 2014-04
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-11-25
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
L Phase Lab Session	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.
L Phase Lab Session	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 L phase lab session will be first. Followed by the F phase lab session.
F Phase Lab session	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.
F Phase Lab session	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 F phase lab session will be first. Followed by the L phase lab session.

Primary Outcome Measures

Name	Time	Method
Change in allopregnanolone levels	6 weeks	The change in ALLO after delivery of the acute stressor will be analyzed.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota Tobacco Research Program; 🇺🇸 Minneapolis, Minnesota, United States