Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

NCT01673087 | Completed Phase 1 FDA Drug

• 1 other identifier: 1R01MH093486-01A1
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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

Keywords

stress biology; cortisol; adrenocorticotropin; salivary biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• corticotropin (ACTH)

  Primarily measuring change from pre-drug baseline to peak occuring about 10 minutes to an hour later

Study Arms (1)

laboratory HPA probes

EXPERIMENTAL

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.

Drug: Metyrapone; Drug: Dexamethasone; Drug: Cortrosyn; Drug: Corticorelin ovine triflutate

Interventions

Metyrapone DRUG

750 mcg, oral, administered twice, 3.5 hours apart

Also known as: Metopirone

laboratory HPA probes

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.

Also known as: Decadron

laboratory HPA probes

Cortrosyn DRUG

250 mcg, IV, bolus, in the afternoon.

Also known as: Cosyntropin

laboratory HPA probes

Corticorelin ovine triflutate DRUG

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

Also known as: Acthrel, Corticotropin-Releasing Hormone

laboratory HPA probes

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Medically healthy volunteers, ages 18 to 50 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Metyrapone; Dexamethasone; Calcium Dobesilate; Cosyntropin; corticorelin ovine; Corticotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Adrenocorticotropic Hormone; Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Pituitary Hormone-Releasing Hormones

Study Officials

• James L Abelson, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 27, 2012
• Study Start: October 1, 2012
• Primary Completion: August 15, 2017
• Study Completion: August 15, 2017
• Last Updated: April 23, 2018

Record last verified: 2018-04

Locations

US (1)