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Brief Stresses Experimental Study

Primary Purpose

DNA Damage, Psychological Stress

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Propranolol

Placebo oral capsule

Acute stress task

No stress task

About this trial

This is an interventional basic science trial for DNA Damage

Eligibility Criteria

20 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 20-59
Weigh at least 110 pounds
Fasting blood sugar below 150 mg/dL, or random blood sugar below 200 mg/dL
Thyroid stimulating hormone level between 0.25 mU/L and 6.0 mU/L
Resting blood pressure below 160/100 mm Hg
If female, have either regular menstrual periods (21-35 days) or are post-menopausal

Exclusion Criteria:

Use of illicit drugs or nicotine-containing products other than cigarettes in the past month
Current alcohol abuse
Diagnosed with any of the following: cancer (other than basal cell skin cancer), chronic obstructive pulmonary disorder (COPD), multiple sclerosis (MS), severe traumatic brain injury, hypertension (high blood pressure), coronary artery disease, congestive heart failure, or other serious heart disease
Current diabetes, asthma, depression, bipolar disorder, anxiety, or schizophrenia
If female, pregnancy or breastfeeding within the past 3 months
If female, taking any medications that prevent monthly menstrual cycles (e.g., birth control shot, IUD, "seasonal" birth control)
Resting systolic blood pressure of < 90 mm Hg or resting pulse < 50 beats per minute

Sites / Locations

UPMC Shadyside

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Propranolol group

Placebo group

Arm Description

This group will receive a single oral dose (80mg) of propranolol in a blinded capsule during their acute stress study visit.

This group will receive a single blinded capsule containing no active medication during their acute stress study visit.

Outcomes

Primary Outcome Measures

DNA Stress Response

Change in percent tail intensity will be measured using the Comet assay of DNA damage in blood samples

Secondary Outcome Measures

DNA Stress Response (8-OHdG)

Change in DNA 8-OHdG levels will be measured in blood samples

DNA Stress Response (γ-H2AX)

Change in cellular γ-H2AX levels will be measured in blood samples

Neuroendocrine Stress Response (Norepinephrine (NE))

Change in circulating plasma NE levels will be measured in blood samples

Neuroendocrine Stress Response (Epinephrine (EPI))

Change in circulating plasma EPI levels will be measured in blood samples

Hematological Stress Response

Change in the white blood cell populations present in blood samples will be measured through complete blood count with differential analysis and flow cytometry

Cardiovascular Stress Response (Heart rate (HR))

Change in HR will be calculated from repeated assessments

Cardiovascular Stress Response (Systolic blood pressure (SBP))

Change in SBP/DBP will be calculated from repeated assessments

Cardiovascular Stress Response (Diastolic blood pressure (DBP))

Change in DBP will be calculated from repeated assessments

Psychological Stress Response (Anxiety Visual Analogue Scale (VAS))

Change in anxiety levels will be assessed by self-report measure (VAS) on a 0 to 100 scale, where 0 indicates not feeling anxious and 100 indicates feeling highly anxious

Psychological Stress Response (Stress Visual Analogue Scale (VAS))

Change in stress levels will be assessed by self-report measure (VAS) on a 0 to 100 scale, where 0 indicates not feeling stressed and 100 indicates feeling highly stressed

Full Information

NCT ID

NCT03893617

First Posted

March 26, 2019

Last Updated

July 17, 2023

Sponsor

Dana Bovbjerg

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03893617

Brief Title

Brief Stresses Experimental Study

Official Title

Brief Stresses and DNA Integrity: An Experimental Analysis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Terminated

Why Stopped

Due to challenges associated with the Covid-19 pandemic, we were unable to complete recruitment as planned during the period we had funding to do so.

Study Start Date

October 5, 2017 (Actual)

Primary Completion Date

January 27, 2022 (Actual)

Study Completion Date

January 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dana Bovbjerg

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

DNA Damage, Psychological Stress

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

239 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Propranolol group

Arm Type

Active Comparator

Arm Description

This group will receive a single oral dose (80mg) of propranolol in a blinded capsule during their acute stress study visit.

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

This group will receive a single blinded capsule containing no active medication during their acute stress study visit.

Intervention Type

Drug

Intervention Name(s)

Propranolol

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo oral capsule

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Acute stress task

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

No stress task

Intervention Description

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.

Primary Outcome Measure Information:

Title

DNA Stress Response

Description

Change in percent tail intensity will be measured using the Comet assay of DNA damage in blood samples

Time Frame

Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute acute stress task period

Secondary Outcome Measure Information:

Title

DNA Stress Response (8-OHdG)

Description

Change in DNA 8-OHdG levels will be measured in blood samples

Time Frame

Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period

Title

DNA Stress Response (γ-H2AX)

Description

Change in cellular γ-H2AX levels will be measured in blood samples

Time Frame

Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period

Title

Neuroendocrine Stress Response (Norepinephrine (NE))

Description

Change in circulating plasma NE levels will be measured in blood samples

Time Frame

Blood samples will be collected after a 60 minute baseline period and during/after the approximately 15 minute task period

Title

Neuroendocrine Stress Response (Epinephrine (EPI))

Description

Change in circulating plasma EPI levels will be measured in blood samples

Time Frame

Blood samples will be collected after a 60 minute baseline period and during/after the approximately 15 minute task period

Title

Hematological Stress Response

Description

Change in the white blood cell populations present in blood samples will be measured through complete blood count with differential analysis and flow cytometry

Time Frame

Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period

Title

Cardiovascular Stress Response (Heart rate (HR))

Description

Change in HR will be calculated from repeated assessments

Time Frame

HR will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period

Title

Cardiovascular Stress Response (Systolic blood pressure (SBP))

Description

Change in SBP/DBP will be calculated from repeated assessments

Time Frame

Blood pressure will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period

Title

Cardiovascular Stress Response (Diastolic blood pressure (DBP))

Description

Change in DBP will be calculated from repeated assessments

Time Frame

Blood pressure will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period

Title

Psychological Stress Response (Anxiety Visual Analogue Scale (VAS))

Description

Change in anxiety levels will be assessed by self-report measure (VAS) on a 0 to 100 scale, where 0 indicates not feeling anxious and 100 indicates feeling highly anxious

Time Frame

Anxiety VAS will be administered after a 60 minute baseline period and during/after completion of the tasks

Title

Psychological Stress Response (Stress Visual Analogue Scale (VAS))

Description

Change in stress levels will be assessed by self-report measure (VAS) on a 0 to 100 scale, where 0 indicates not feeling stressed and 100 indicates feeling highly stressed

Time Frame

Stress VAS will be administered after a 60 minute baseline period and during/after completion of the tasks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 20-59 Weigh at least 110 pounds Fasting blood sugar below 150 mg/dL, or random blood sugar below 200 mg/dL Thyroid stimulating hormone level between 0.25 mU/L and 6.0 mU/L Resting blood pressure below 160/100 mm Hg If female, have either regular menstrual periods (21-35 days) or are post-menopausal Exclusion Criteria: Use of illicit drugs or nicotine-containing products other than cigarettes in the past month Current alcohol abuse Diagnosed with any of the following: cancer (other than basal cell skin cancer), chronic obstructive pulmonary disorder (COPD), multiple sclerosis (MS), severe traumatic brain injury, hypertension (high blood pressure), coronary artery disease, congestive heart failure, or other serious heart disease Current diabetes, asthma, depression, bipolar disorder, anxiety, or schizophrenia If female, pregnancy or breastfeeding within the past 3 months If female, taking any medications that prevent monthly menstrual cycles (e.g., birth control shot, IUD, "seasonal" birth control) Resting systolic blood pressure of < 90 mm Hg or resting pulse < 50 beats per minute

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dana Bovbjerg, PhD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Frank Jenkins, PhD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

UPMC Shadyside

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

12. IPD Sharing Statement

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Brief Stresses Experimental Study

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