Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures
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|ClinicalTrials.gov Identifier: NCT01673087|
Recruitment Status : Completed
First Posted : August 27, 2012
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stress||Drug: Metyrapone Drug: Dexamethasone Drug: Cortrosyn Drug: Corticorelin ovine triflutate||Phase 4|
|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|
|Primary Completion Date :||August 15, 2017|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|