Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

NCTNCT01673087Other id1R01MH093486-01A1

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 256 participants (actual)
Sponsor: University of Michigan · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Oct 2012
Primary completion: 15 Aug 2017
Completion: 15 Aug 2017
First posted: 27 Aug 2012 (estimated)
Last update posted: 23 Apr 2018
Conditions: Stress

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2012201320142015201620172018

Ph 1
Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures
NCT01673087
Oct 2012 to 15 Aug 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

MetyraponeDrug
DexamethasoneDrug
CortrosynDrug
Corticorelin ovine triflutateDrug

Arms1

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.

Primary outcomes1

Outcomes the sponsor listed as primary.

cortisol levels
Time frame · Primarily measuring change from pre-drug baseline to peak occuring about 20 minutes to an hour later
Registry description
cortisol measured in saliva and in blood.

Secondary outcomes(1)

corticotropin (ACTH)
Time frame · Primarily measuring change from pre-drug baseline to peak occuring about 10 minutes to an hour later
Registry description
ACTH will be measured in blood using chemoluminescence detection.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 50 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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