Stress and the Nervous System

Description

Models of stress such as hypoglycemia have identified that stress results the next day in decreased baroreflex sensitivity. This project will test the hypothesis that these delayed changes in autonomic nervous system function are secondary to a rise in ACTH. The investigators will infuse cosyntropin versus placebo in a double-blind, crossover study in healthy adults and measure the delayed effects on the autonomic system as measured by cardiovagal baroreflex sensitivity.

Study Start Date

January 2015

Estimated Completion Date

March 2016

Interventions

  • Drug: Cosyntropin
  • Drug: Placebo

Specialties

  • Neurology: Neuro/Psych pharmacology
  • Pharmacy: Neuro/Psych pharmacology

MeSH Terms

  • Autonomic Nervous System
  • Cosyntropin

Study ID

Brigham and Women's Hospital -- 2014P002423

Status

Unknown

Trial ID

NCT02339506

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

60

Sponsor

Brigham and Women's Hospital

Inclusion Criteria

    Subjects must be currently healthy, BMI 18-30 kg/m2, and not be on any medications. This study will recruit men and women. Due to concerns about estrogen's effects on hormone levels and possible contributions of menstrual symptoms on pain sensing thresholds, we will schedule the inpatient studies to avoid the early follicular phase in normally cycling women and exclude women on oral birth control. Subjects must have normal laboratory values for: 1. Complete blood count 2. Serum creatinine, sodium, potassium, glucose, liver enzymes 3. Urinalysis 4. Urine pregnancy test (if female) 5. Normal ECG

Exclusion Criteria

    We will exclude individuals with:
  • Systolic blood pressure > 140 or < 90 mm Hg
  • Diastolic blood pressure > 90 mm Hg
  • Creatinine clearance ? 60 mL/min, as calculated by MDRD formula
  • Known DM, CHF, CAD, PVD, CVA, MI, asthma
  • Known or history of Cushing's disease or adrenal insufficiency
  • Known neurologic disease
  • Known psychiatric disease
  • Steroid use (oral or inhaled, local or systemic injections, within the past 6 months)
  • Significant concomitant medical illnesses
  • Current excessive alcohol (>10oz ethanol/week)
  • Current use of recreational drugs
  • Current smokers
  • Current pregnancy
  • Chronic use of non-steroidal anti-inflammatory or narcotic medications
  • Evidence of ischemia or heart block on screening electrocardiogram (greater than type I-second degree heart block, left bundle branch block, or ST-T wave changes in 2 or more contiguous leads)
  • Subjects taking any prescription medications (including oral birth control pills) or herbal medications will be excluded.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Gail K Adler MD PhD 617-732-6660 gadler@partners.org

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.