Clinical Trials Related to Acthrel (Corticorelin Ovine Triflutate)
Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures [Recruiting]
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.
Corticotropin Releasing Hormone (CRH) Responsiveness in Children With Functional Dyspepsia [Not yet recruiting]
Chronic abdominal pain is the most common persistent pain condition in children and
adolescents, affecting 10-15% of children at any given time. One of the most often diagnosed
types of abdominal pain is functional dyspepsia (FD). FD is an abdominal pain or discomfort
(e. g., nausea, bloating) in the upper abdomen that does not get better by going to the
For some people it appears that stress can make FD worse. In adults, stress can cause the
release of a hormone called corticotropin releasing hormone (CRH). The release of CRH can
cause abdominal pain by affecting how fast things move through a person's stomach and
intestines. This makes the organs in the abdomen more sensitive to pain, causing tenderness
of the inside lining of the stomach and intestines.
Different people react differently when the body releases CRH. Some people have abdominal
pain without feeling any stress or anxiety while other people who have a lot of stress or
anxiety don't have any abdominal pain. Some people have neither stress, anxiety, or
abdominal pain when CRH is released into the body.
In order to see how the bodies of children with functional dyspepsia and those without
functional dyspepsia react to CRH, we will do a CRH stimulation test. A CRH stimulation
test is routinely done in endocrine patients. It is not routinely done for patients with
functional dyspepsia or for patients who do not have functional dyspepsia.
Part of the CRH stimulation test is giving a synthetic type of corticotropin, Acthrel®
(brand name for Corticorelin), as injection. Acthrel® has been approved by the Food and
Drug Administration (FDA) for use.
The purpose of this research study is to see if there are differences in how the bodies of
children with functional dyspepsia react to CRH versus children who don't have functional
Being in this study involves one clinic visit where an IV placed and a CRH stimulation
test. In this test the child will be given an injection of CRH and then observed for one
hour. During that hour the child will have five blood draws through the IV and will be
asked questions about their anxiety and abdominal pain. This visit will take about 4 hours.
The following things will happen:
- Your child will be asked to come to the clinic between 8a. m. and 10a. m. fasting. This
means your child will have had nothing to eat or drink for 8 hours before coming to the
- If your child is a female ten years of age or older, or has started having periods, a
urine pregnancy test will be done before receiving the CRH infusion.
- You and your child will each be asked to complete a survey that measures your child's
- Your child will have a biofeedback session that will measure your child's stress. In a
biofeedback session, sensors are placed on your child's fingers, wrists and forehead.
These sensors are connected to a computer that monitors your child's heartbeat, skin
temperature and electrical pulses on your child's skin.
- Your child will have an IV inserted into a vein in his/her arm. Your child may have a
cream put on their arm to help with the pain of the IV insertion. The IV will be used
to inject the CRH and draw blood. If the IV stops working and blood samples can no
longer be drawn from it, your child may have another IV started or blood samples may be
drawn by needle stick.
- Your child will then have 30 minutes to relax.
- Your child will then have CRH infused through the IV over one minute.
- Your child will have blood drawn through the IV five times; right before the CRH
stimulation test begins and 15, 30, 45 and 60 minutes after the CRH infusion. The
total amount of blood drawn for the study will be about 2 ½ tablespoons.
- Your child will be asked about their abdominal pain, nausea, bloating, stress and
anxiety at three separate times during the 60 minutes.
- Your child's heart rate will be measured throughout the CRH stimulation test.
Effects of Hormone Stimulation on Brain Scans for Cushing s Disease [Recruiting]
- Cushing s disease can be caused by a tumor of the pituitary gland, a small gland
about the size of a pea located at the base of the brain. These tumors produce high
levels of hormones, which cause obesity, diabetes, and growth problems. The cure for
this type of Cushing s disease is to have surgery that removes the tumor but leaves
the pituitary gland alone. Currently, magnetic resonance imaging scans are the best way
to find these tumors. However, many of these tumors do not show up on the scan.
- Positron emission tomography (PET) scans use radioactive chemicals to light up parts of
the body that are more active, such as tumors. Researchers want to try to make the
small Cushing s disease tumors more active to help them show up on the scans. A
special hormone will be given before the scan to make the tumors more active.
- To test the use of hormone stimulation to improve brain scans for Cushing s disease
- Individuals at least 8 years of age who will be having surgery to remove Cushing s
- Participants will be screened with a medical history, physical exam, blood and urine
tests, and imaging studies.
- They will have three brain scans before surgery. The first scan is a magnetic resonance
imaging scan to show a full picture of the brain. The second and third scans are PET
- The first PET scan will be given without the special hormone. The second PET scan will
be done more than 24 hours but less than 14 days after the first PET scan. The second
PET scan will be given with the special hormone.
- Participants will have tumor removal surgery through another study protocol.
Gender and Neural Substrates of Stress and Craving [Completed]
Cocaine dependence is an insidious disease underscored by a powerful proclivity to relapse
despite an individual's ability to recognize the deleterious consequences of continued drug
use. To date, there are only a limited number of treatments, and no FDA approved
medications for the treatment of cocaine dependence. Attempts to find reliable and
successful treatments for cocaine dependence may be marred by gender differences in brain
chemistry, structure, and function that are manifested as drug craving and relapse. For
example, cues, drug exposure, and stress promote relapse, yet females appear be more
susceptible to stress induced relapse, while males may be more susceptible to cue induced
relapse. Therefore identifying the neural substrates involved in processing the valence of
internal and external stimuli may provide further insight into cocaine dependence and
provide more effective therapeutic strategies aimed at preventing relapse.
Corticotropin releasing hormone (CRH) is a pharmacological activator of the hypothalamic
pituitary adrenal (HPA) axis, and has been implicated in stress induced drug relapse.
Corticotropin releasing hormone receptors are located at extrahypothalamic brain nuclei that
have been implicated in determining the significance of both internal (somatic) and external
(environmental) stimuli. The primary directive of this pilot project is to utilize
functional magnetic resonance imaging (fMRI) to identify possible brain nuclei associated
with with stress induced drug craving in cocaine dependent females.