NCT03893617

Brief Stresses Experimental Study

Brief Stresses and DNA Integrity: An Experimental Analysis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Dana Bovbjerg · Academic / Other
• Sex: All
• Age: 20 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to examine the impact of psychological stress on DNA integrity by conducting an experiment under controlled conditions with healthy volunteers to directly test the extent to which acute stress increases DNA damage, while simultaneously testing the blocking effects of pre-treatment with propranolol, and exploring key hypothesized mediators and moderators of the severity of the DNA damage.

Conditions

• DNA Damage
• Psychological Stress

Interventions

Type	Name	Description
DRUG	Propranolol	A single oral dose (80mg) of propranolol will be administered in a blinded capsule at the start of the baseline monitoring period of the acute stress study visit.
DRUG	Placebo oral capsule	A single blinded capsule containing no active medication will be administered at the start of the baseline monitoring period of the acute stress study visit.
BEHAVIORAL	Acute stress task	Participants will complete speech and arithmetic tasks, performed in front of an audience (e.g., researcher staff members) and recorded by a video camera to assess non-verbal behaviors and evaluate performance. The task will be initiated following completion of baseline sample collection during the acute stress study visit and will take approximately 15 minutes.
BEHAVIORAL	No stress task	Participants will sit quietly for 5 minutes, read a short passage aloud for 5 minutes, and read a list of numbers aloud for 5 minutes. The task will be initiated following completion of baseline sample collection during the no stress study visit and will take approximately 15 minutes.

Timeline

• Start date: 2017-10-05
• Primary completion: 2022-01-27
• Completion: 2022-01-27
• First posted: 2019-03-28
• Last updated: 2023-07-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study