Smoking, Stress & Allopregnanolone Response

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087800
• Other study ID #: 2013NTLS120
• Status: Completed
• Phase: N/A
• First received: March 12, 2014
• Last updated: November 25, 2015
• Start date: April 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota Tobacco Research Program	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in allopregnanolone levels	The change in ALLO after delivery of the acute stressor will be analyzed.	6 weeks	No
Secondary	Change in mood	We will analyze ALLO levels and mood to see if there is an association between the two.	6 weeks	No
Secondary	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	No