Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures
|ClinicalTrials.gov Identifier: NCT01673087|
Recruitment Status : Completed
First Posted : August 27, 2012
Last Update Posted : April 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stress||Drug: Metyrapone Drug: Dexamethasone Drug: Cortrosyn Drug: Corticorelin ovine triflutate||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||256 participants|
|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|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||August 15, 2017|
|Actual Study Completion Date :||August 15, 2017|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673087
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||James L Abelson, MD||University of Michigan|