Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
James Abelson, University of Michigan
ClinicalTrials.gov Identifier:
NCT01673087
First received: August 16, 2012
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Stress
Drug: Metyrapone
Drug: Dexamethasone
Drug: Cortrosyn
Drug: Corticorelin ovine triflutate
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • cortisol levels [ Time Frame: Primarily measuring change from pre-drug baseline to peak occuring about 20 minutes to an hour later ] [ Designated as safety issue: No ]
    cortisol measured in saliva and in blood.


Secondary Outcome Measures:
  • corticotropin (ACTH) [ Time Frame: Primarily measuring change from pre-drug baseline to peak occuring about 10 minutes to an hour later ] [ Designated as safety issue: No ]
    ACTH will be measured in blood using chemoluminescence detection.


Estimated Enrollment: 350
Study Start Date: October 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673087

Contacts
Contact: Hedieh Briggs, MSW 734-764-5349 hedieh@umich.edu
Contact: Erin McRobert, MSW 734-232-0200 erinmcro@umich.edu

Locations
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: James L Abelson, MD    734-764-5348    jabelson@umich.edu   
Principal Investigator: James L Abelson, MD         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: James L Abelson, MD University of Michigan
  More Information

No publications provided

Responsible Party: James Abelson, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01673087     History of Changes
Other Study ID Numbers: 1R01MH093486-01A1
Study First Received: August 16, 2012
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
stress biology
cortisol
adrenocorticotropin
salivary biomarkers

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Corticotropin-Releasing Hormone
BB 1101
Metyrapone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites

ClinicalTrials.gov processed this record on September 22, 2014