Brief Stresses Experimental Study

NCT03893617 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2023-07-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Dana Bovbjerg

    lead OTHER

Principal Investigators

  • Dana Bovbjerg, PhD · University of Pittsburgh

  • Frank Jenkins, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2022-01-27
Completion
2022-01-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03893617 on ClinicalTrials.gov