Does Treating Anxiety Symptoms With ACT Improve Vascular Inflammation and Function? (ACT on Anxiety)

This is an interventional treatment trial for Anxiety Read More

Inclusion Criteria:

• Willing and able to provide written, signed consent after the nature of the study has been explained, and prior to any research-related procedures.
• Age is > or = 25 and < or = 65 years of age.
• Healthy, as determined by health history questionnaire, blood chemistries, and 12-lead ECG.
• Blood chemistries indicative of normal renal (creatinine <2.0mg/dl), liver (<3 times upper limit for ALT, AST), and thyroid function (TSH between 0.4 - 5.0 mU/L) or on stable thyroid medication with no dose change for 3 months.
• If currently receiving treatment with or taking any of the following supplements, must be willing and able to discontinue taking for 2 weeks prior to each study visit and/or throughout the treatment period: Vitamin C, E or other multivitamins containing vitamin C or E; omega-3 fatty acids; Phosphodiesterase (PDE) 5 inhibitors (i.e. Viagra®, Cialis®, Levitra®, or Revatio®); PDE 3 inhibitors (e.g., cilostazol (Pletal®), milrinone, or vesnarinone).
• No history of cardiovascular disease (e.g., heart attack, stroke, heart failure, valvular heart disease, cardiomyopathy), or peripheral arterial disease.
• Non-smokers, defined as no history of smoking or no smoking for at least the past 3 months.
• Normal resting 12-lead ECG (no evidence of myocardial infarction, left ventricular hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block, atrial fibrillation/flutter. atherosclerosis).

Exclusion Criteria:

• Current diagnosis or history of cancer, liver disease, HIV/AIDS
• History of brain tumor, aneurysm or injury
• Clinical diagnosis of mental health disorders such as bipolar disorder or schizophrenia
• History of cardiovascular disease such as heart angioplasty/stent or bypass surgery, myocardial infarction, stroke, heart failure with or without LV ejection fraction <40%, cardiomyopathy, valvular heart disease, cardiomyopathy, heart transplantation, atherosclerosis.
• Current tobacco user or history of tobacco use within the past 3 months (cigarettes, cigars, chewing tobacco, Hookah).
• History of lung emphysema, chronic bronchitis or chronic obstructive pulmonary disease (COPD).
• Abnormal resting 12-lead ECG (e.g., evidence of myocardial infarction, left ventricular hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block, atrial fibrillation/flutter, atherosclerosis).
• Serious neurologic disorders including seizures.
• History of renal failure, dialysis or kidney transplant.
• Use of any investigational products or investigational medical devices within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
• Recent flu-like symptoms within the past 2 weeks.
• Pregnant or breastfeeding at screening, or planning to become pregnant (self or partner) at any time during the study. A urinary pregnancy test will be done on all females. If test is positive, the subject will be excluded.
• History of rheumatoid arthritis, Grave's disease, systemic lupus erythematosis, and Wegener's granulomatosis.
• Taking anticoagulation, anti-seizure, or antipsychotic agents.
• Start of or dose change to an antidepressant or anti-anxiety medication within the past 3 months (if no change in medication or dose in past 3 month, then subject will be eligible).
• Intention to start or current psychotherapy for anxiety and/or depression while enrolled in study.
• Immunodeficiency or systemic autoimmune disease.
• History of bleeding disorders or conditions of the microcirculation (i.e. von Willebrand disease, Raynaud's disease).
• History of co-morbid condition that would limit life expectancy to <1 year.
• Taking chronic non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, indomethacin, naproxen, acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®) and not able or willing to go off of for 2 weeks prior to each study visit.
• Taking cox-2 inhibitors (Celebrex®, Vioxx®, etc) or allopurinol (Zyloprim®, Lopurin®, Aloprim®).
• Taking steroids or biologics: corticosteroids (prednisone); methotrexate, infliximab (Remicade®), etanercept (Enbrel®); anakinra (Kineret®).
• Vulnerable populations (prisoners, etc.) will not be eligible to participate in this study.
• Current alcohol abuse.
• On weight loss drugs (i.e. orlistat (Xenical®), sibutramine (Meridia®), phenylpropanol-amine (Acutrim®)), or similar over-the-counter medications within 3 months of screening.
• Any condition that, in the view of the PI or Co-I, places the subject at high risk or poor treatment and study compliance.