Disentangling Anxiety Sensitivity and Anxiety-induced Physiological Stress Response

NCT02372110 | Completed Phase 4

• 1 other identifier: 2015010023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Heart Rate

  continuous heart rate monitoring

  180 minutes

Study Arms (2)

HPA, ANS stimulation

EXPERIMENTAL

Oral administration of 400mg caffeine and 20mg hydrocortisone will stimulate HPA axis and ANS activity, respectively

Drug: HPA, ANS stimulation

Two cellulose placebo capsules

PLACEBO COMPARATOR

two cellulose capsule filled with acidophilus powder will be administered orally

Drug: Placebo

Interventions

HPA, ANS stimulation DRUG

Oral administration of Hydrocortisone will increase HPA axis activity. Oral administration of Caffeine will boost ANS activity

Also known as: vivarin, cortef

HPA, ANS stimulation

Placebo DRUG

Two cellulose placebo capsules filled with acidophilus powder will be administered to subjects who are randomly assigned to the placebo condition

Also known as: fake pill

Two cellulose placebo capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Caffeine; Hydrocortisone

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Robert A Josephs, Ph.D

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 26, 2015
• Study Start: March 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

US (1)