Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

Study Overview
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Brief Summary
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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.

Official Title
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Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

Conditions
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Stress

Intervention / Treatment
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* Drug: Metyrapone
* Drug: Dexamethasone
* Drug: Cortrosyn
* Drug: Corticorelin ovine triflutate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laboratory HPA probes<br>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<br>* 750 mcg, oral, administered twice, 3.5 hours apart<br>* Other names: Metopirone;Drug: Dexamethasone<br>* 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.<br>* Other names: Decadron;Drug: Cortrosyn<br>* 250 mcg, IV, bolus, in the afternoon.<br>* Other names: Cosyntropin;Drug: Corticorelin ovine triflutate<br>* 100 mcg, IV, over 30 seconds, in the afternoon.<br>* Other names: Corticotropin-Releasing Hormone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cortisol levels | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress biology, cortisol, adrenocorticotropin, salivary biomarkers