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Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01673087
Enrollment
256
Registered
2012-08-27
Start date
2012-10-31
Completion date
2017-08-15
Last updated
2018-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress

Keywords

stress biology, cortisol, adrenocorticotropin, salivary biomarkers

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.

Interventions

750 mcg, oral, administered twice, 3.5 hours apart

DRUGDexamethasone

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.

250 mcg, IV, bolus, in the afternoon.

DRUGCorticorelin ovine triflutate

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

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
cortisol levelsPrimarily measuring change from pre-drug baseline to peak occuring about 20 minutes to an hour latercortisol measured in saliva and in blood.

Secondary

MeasureTime frameDescription
corticotropin (ACTH)Primarily measuring change from pre-drug baseline to peak occuring about 10 minutes to an hour laterACTH will be measured in blood using chemoluminescence detection.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026