Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

NCT ID: NCT01673087

Last Updated: 2018-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2017-08-15

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.

Conditions

Stress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

laboratory HPA probes

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.

Group Type: EXPERIMENTAL

Metyrapone

Intervention Type: DRUG

750 mcg, oral, administered twice, 3.5 hours apart

Dexamethasone

Intervention Type: 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.

Cortrosyn

Intervention Type: DRUG

250 mcg, IV, bolus, in the afternoon.

Corticorelin ovine triflutate

Intervention Type: DRUG

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

Interventions

Metyrapone

750 mcg, oral, administered twice, 3.5 hours apart

Intervention Type: 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.

Intervention Type: DRUG

Cortrosyn

250 mcg, IV, bolus, in the afternoon.

Intervention Type: DRUG

Corticorelin ovine triflutate

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

Intervention Type: DRUG

Other Intervention Names

Metopirone; Decadron; Cosyntropin; Acthrel; Corticotropin-Releasing Hormone

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

James Abelson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James L Abelson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Health System

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

1R01MH093486-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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