Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT01673087

Collaborator

(none)

256

Enrollment

Location

Arm

58.4

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Oct 1, 2012

Actual Primary Completion Date :

Aug 15, 2017

Actual Study Completion Date :

Aug 15, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

cortisol levels [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

corticotropin (ACTH) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

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