Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

April 19, 2018 updated by: James Abelson, University of Michigan
Cortisol is a stress hormone that can be measured in saliva. This has provided a convenient way to evaluate the biological impact of day-to-day stressors that people encounter as they go about their lives, since saliva is so easy to collect. However, the biological meaning of saliva cortisol measures has never been carefully examined. The goal of this study is to collect saliva from a large group of people as they go about their every-day lives, to measure their cortisol levels, and then study them in the laboratory where Investigators can learn more about how their stress response system (which produces cortisol) is really functioning. Investigators can then determine much more precisely what saliva cortisol levels really mean in terms of stress system biology. This will allow investigators to obtain much more useful information from the next decade of research on naturalistic stress and its biological impact using saliva cortisol measures, helping investigators to understand how stress undermines health and how to combat this effect.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medically healthy volunteers, ages 18 to 50 years

Exclusion Criteria:

  • Pregnancy
  • Irregular menses, medications or drugs that effect HPA axis
  • Most psychiatric disorders
  • Medical problems that effect HPA axis or increase risks involved in participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: laboratory HPA probes

All subjects will be studied with multiple probes of HPA axis function over the course of one to two months:

Metyrapone, oral, 750 mg, administered twice 3.5 hrs apart; Dexamethasone, oral, 1.5 mg administered once; oral, 0.25 mg administered once; Corticorelin ovine triflutate (CRH), intravenous, 100 mcg, administered once over 30 seconds; Cortrosyn (ACTH), intravenous, 250 mcg, administered once by bolus.
Drug: Metyrapone
750 mcg, oral, administered twice, 3.5 hours apart
Other Names:
  • Metopirone
Drug: Dexamethasone

Administered twice:

1.5 mg, oral, at 11 pm And 0.25 mg, oral, at bedtime at least one week before or after other administration.

Other Names:
  • Decadron
Drug: Cortrosyn
250 mcg, IV, bolus, in the afternoon.
Other Names:
  • Cosyntropin
Drug: Corticorelin ovine triflutate
100 mcg, IV, over 30 seconds, in the afternoon.
Other Names:
  • Acthrel
  • Corticotropin-Releasing Hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cortisol levels
Time Frame: Primarily measuring change from pre-drug baseline to peak occuring about 20 minutes to an hour later
cortisol measured in saliva and in blood.
Primarily measuring change from pre-drug baseline to peak occuring about 20 minutes to an hour later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corticotropin (ACTH)
Time Frame: Primarily measuring change from pre-drug baseline to peak occuring about 10 minutes to an hour later
ACTH will be measured in blood using chemoluminescence detection.
Primarily measuring change from pre-drug baseline to peak occuring about 10 minutes to an hour later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: James L Abelson, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

August 15, 2017

Study Completion (Actual)

August 15, 2017

Study Registration Dates

First Submitted

August 16, 2012

First Submitted That Met QC Criteria

August 24, 2012

First Posted (Estimate)

August 27, 2012

Study Record Updates

Last Update Posted (Actual)

April 23, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01MH093486-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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