Disentangling Anxiety Sensitivity and Anxiety-induced Physiological Stress Response

Completed · Phase 4 · Has a placebo group

Conditions studied: Anxiety

In brief

The proposed study aims to investigate experimentally anxiety sensitivity and physiologic sensations associated with anxiety using a paradigm combining hydrocortisone, caffeine, and a set of social stress challenges. Following informed consent, participants will be instructed to ingest either 400 milligrams of caffeine (an amount of caffeine roughly equivalent to that in two 8 oz. cups of brewed coffee from Starbucks), and 20 milligrams of hydrocortisone or two placebo capsules via stratified, random assignment. Physiologic and self-reported measures of stress and anxiety will be taken.

Key facts

Study ID

NCT02372110

Run by

University of Texas at Austin

People needed

120

Starts

2015-03-01

Expected to finish

2015-11-01

Last updated by the study team

2021-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Both male and female participants will be required to pass the telephone-screening questionnaire. All eligible participants will be 18 years and older.

You may not qualify if…

• Full physiological exclusions include: abnormal electrocardiogram (i.e., arrhythmias), allergy to hydrocortisone or caffeine, anemia, cancer, chronic pain, compromised immune system (e.g., HIV), congestive heart failure, diabetes, diverticulitis, epilepsy, gastroesophageal reflux disease, gastrointestinal disease (e.g., bleeding), heart disease, hepatic impairment, herpes virus, high blood pressure or low blood pressure, high cholesterol, history of stroke, hypothyroidism, infection/fever in the last 7 days, kidney disease, liver disease (e.g., hepatitis), migraines/chronic headaches, myasthenia gravis, ocular herpes simplex virus, osteoporosis, peptic ulcer disease, renal impairment, respiratory disease (e.g., asthma), seizure disorder, skeletal muscle disease, spastic colon, strongyloides infection, surgeries within the last 6 weeks, systemic fungal infection, thyroid disease, tuberculosis/history of positive tuberculosis test, and ulcerative colitis.
• Full medication exclusions include: ADHD medication, antibiotics in the last 7 days, antidepressants, antiplatelet drugs, anxiolytics, bipolar disorder medication, blood pressure medication, blood thinners, bronchodilators, drugs for allergies, drugs to treat hormonal disorders, estrogen, insulin, live vaccinations in the last 7 days, long-lasting decongestants, pain killers (i.e., NSAIDS: aspirin or ibuprofen), sleeping pills, statins (i.e., to lower cholesterol), steroids.
• Full psychological exclusions include current or previous diagnosis of major depression, posttraumatic stress disorder, specific phobia, anxiety disorders, or any other psychiatric condition.

Where it is running

• University of Texas at Austin — Austin, Texas, United States

Full record on ClinicalTrials.gov

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