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Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

NCT01673087 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2018-04-23

No results posted yet for this study

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.

Conditions

  • Stress

Interventions

DRUG

Metyrapone

750 mcg, oral, administered twice, 3.5 hours apart

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.

DRUG

Cortrosyn

250 mcg, IV, bolus, in the afternoon.

DRUG

Corticorelin ovine triflutate

100 mcg, IV, over 30 seconds, in the afternoon.

Sponsors & Collaborators

Principal Investigators

  • James L Abelson, MD · University of Michigan

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2017-08-15
Completion
2017-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01673087 on ClinicalTrials.gov