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OpenTrials
Completed

NCT Number: NCT01673087

Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metyrapone

Drug

750 mcg, oral, administered twice, 3.5 hours apart

Other names: Metopirone

Dexamethasone

Drug

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

Cortrosyn

Drug

250 mcg, IV, bolus, in the afternoon.

Other names: Cosyntropin

Corticorelin ovine triflutate

Drug

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

Other names: Acthrel, Corticotropin-Releasing Hormone

Primary outcomes

  1. cortisol levels

    Time frame: 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 outcomes

  1. corticotropin (ACTH)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Aug 27, 2012
Registry last updated
Apr 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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