Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures
|Stress||Drug: Metyrapone Drug: Dexamethasone Drug: Cortrosyn Drug: Corticorelin ovine triflutate||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
|Official Title:||Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures|
- 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.
- 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.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||June 30, 2018|
|Estimated Primary Completion Date:||June 30, 2018 (Final data collection date for primary outcome measure)|
Experimental: 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.
750 mcg, oral, administered twice, 3.5 hours apart
Other Name: MetopironeDrug: Dexamethasone
1.5 mg, oral, at 11 pm And 0.25 mg, oral, at bedtime at least one week before or after other administration.
Other Name: DecadronDrug: Cortrosyn
250 mcg, IV, bolus, in the afternoon.
Other Name: CosyntropinDrug: Corticorelin ovine triflutate
100 mcg, IV, over 30 seconds, in the afternoon.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673087
|Contact: Hedieh Briggs, MSWemail@example.com|
|Contact: Erin McRobert, MSWfirstname.lastname@example.org|
|United States, Michigan|
|University of Michigan Health System||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: James L Abelson, MD 734-764-5348 email@example.com|
|Principal Investigator: James L Abelson, MD|
|Principal Investigator:||James L Abelson, MD||University of Michigan|