Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

Stress Clinical Trial

Official title:

Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673087
• Other study ID #: 1R01MH093486-01A1
• Status: Completed
• Phase: Phase 1
• First received: August 16, 2012
• Last updated: April 19, 2018
• Start date: October 2012
• Est. completion date: August 15, 2017

Study information

• Verified date: April 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: August 15, 2017
• Est. primary completion date: August 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

Drug:
• Metyrapone
750 mcg, oral, administered twice, 3.5 hours apart
• 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.
• Cortrosyn
250 mcg, IV, bolus, in the afternoon.
• Corticorelin ovine triflutate
100 mcg, IV, over 30 seconds, in the afternoon.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cortisol levels	cortisol measured in saliva and in blood.	Primarily measuring change from pre-drug baseline to peak occuring about 20 minutes to an hour later
Secondary	corticotropin (ACTH)	ACTH will be measured in blood using chemoluminescence detection.	Primarily measuring change from pre-drug baseline to peak occuring about 10 minutes to an hour later