We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01673087
Recruitment Status : Completed
First Posted : August 27, 2012
Last Update Posted : April 23, 2018
Information provided by (Responsible Party):
James Abelson, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stress Drug: Metyrapone Drug: Dexamethasone Drug: Cortrosyn Drug: Corticorelin ovine triflutate Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures
Study Start Date : October 2012
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : August 15, 2017

Resource links provided by the National Library of Medicine

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 Name: 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 Name: Decadron

Drug: Cortrosyn
250 mcg, IV, bolus, in the afternoon.
Other Name: Cosyntropin

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673087

Layout table for location information
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Layout table for investigator information
Principal Investigator: James L Abelson, MD University of Michigan
Layout table for additonal information
Responsible Party: James Abelson, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01673087    
Other Study ID Numbers: 1R01MH093486-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2012    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James Abelson, University of Michigan:
stress biology
salivary biomarkers
Additional relevant MeSH terms:
Layout table for MeSH terms
Adrenocorticotropic Hormone
Corticotropin-Releasing Hormone
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors