StressPhase 1NCT01673087
Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures
A Phase 1 study testing Metyrapone, Dexamethasone and Cortrosyn in people with Stress, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Metyrapone, Dexamethasone and Cortrosyn
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 15 Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically healthy volunteers, ages 18 to 50 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
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
- Being tested
- Metyrapone, Dexamethasone, Cortrosyn, Corticorelin ovine triflutate
- Keywords
- stress biology, cortisol, adrenocorticotropin, salivary biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetyraponeDrug
Also called Metopirone
750 mcg, oral, administered twice, 3.5 hours apart
DexamethasoneDrug
Also called Decadron
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.
CortrosynDrug
Also called Cosyntropin
250 mcg, IV, bolus, in the afternoon.
Corticorelin ovine triflutateDrug
Also called Acthrel, Corticotropin-Releasing Hormone
100 mcg, IV, over 30 seconds, in the afternoon.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Metyrapone; Drug: Dexamethasone; Drug: Cortrosyn; Drug: Corticorelin ovine triflutate |
What is being measured
The primary outcome is the main question the study is designed to answer.
cortisol levels
cortisol measured in saliva and in blood.
Measured: Primarily measuring change from pre-drug baseline to peak occuring about 20 minutes to an hour later
Secondary outcomes (1)
corticotropin (ACTH)
ACTH will be measured in blood using chemoluminescence detection.
Measured: Primarily measuring change from pre-drug baseline to peak occuring about 10 minutes to an hour later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startOct 2012
- Primary completion15 Aug 2017
- Study completion15 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Abelson, University of Michigan
- Investigators
- James L Abelson, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673087
- Sponsor's protocol ID
- 1R01MH093486-01A1
- Status last verified
- Apr 2018
- First submitted
- 16 Aug 2012
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures
- ClinicalTrials.gov ID
- NCT01673087
- Acronym / sponsor ID
- 1R01MH093486-01A1
- Conditions
- Stress
- Keywords
- stress biology, cortisol, adrenocorticotropin, salivary biomarkers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laboratory HPA probes | Experimental | Drug: Metyrapone, Drug: Dexamethasone, Drug: Cortrosyn, Drug: Corticorelin ovine triflutateAll 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Medically healthy volunteers, ages 18 to 50 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetyraponeAlso: Metopirone750 mcg, oral, administered twice, 3.5 hours apart | Drug | laboratory HPA probes |
| DexamethasoneAlso: DecadronAdministered twice: 1.5 mg, oral, at 11 pm And 0.25 mg, oral, at bedtime at least one week before or after other administration. | Drug | laboratory HPA probes |
| CortrosynAlso: Cosyntropin250 mcg, IV, bolus, in the afternoon. | Drug | laboratory HPA probes |
| Corticorelin ovine triflutateAlso: Acthrel, Corticotropin-Releasing Hormone100 mcg, IV, over 30 seconds, in the afternoon. | Drug | laboratory HPA probes |
Primary outcome
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.
1 secondary outcome
corticotropin (ACTH)
Time frame: Primarily measuring change from pre-drug baseline to peak occuring about 10 minutes to an hour later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James L Abelson, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metyrapone, Dexamethasone and Cortrosyn in people with Stress, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cortisol levels (time frame: Primarily measuring change from pre-drug baseline to peak occuring about 20 minutes to an hour later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.