Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

University of Michigan

Status and phase: Completed; Phase 1

Conditions: Stress

Treatments: Drug: Dexamethasone; Drug: Cortrosyn; Drug: Metyrapone; Drug: Corticorelin ovine triflutate

Study type: Interventional

Funder types: Other

Identifiers

NCT01673087

1R01MH093486-01A1

Details and patient eligibility

About

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.

Enrollment: 256 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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256 participants in 1 patient group

laboratory HPA probes

Experimental group

Description:

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.

Treatment:

Drug: Corticorelin ovine triflutate

Drug: Metyrapone

Drug: Cortrosyn

Drug: Dexamethasone