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Smoking, Stress & Allopregnanolone Response

NCT ID: NCT02087800

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Smoking Cessation

Keywords

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smoking cessation smoking abstinence allopregnanolone

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

F phase lab session

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alicia Allen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota Tobacco Research Program

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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2013NTLS120

Identifier Type: -

Identifier Source: org_study_id