Brief Stresses Experimental Study

Psychological Stress Clinical Trial

Official title:

Brief Stresses and DNA Integrity: An Experimental Analysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03893617
• Other study ID #: PRO16080092
• Secondary ID: R01CA211371
• Status: Terminated
• Phase: Phase 1
• Start date: October 5, 2017
• Est. completion date: January 27, 2022

Study information

• Verified date: July 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 239
• Est. completion date: January 27, 2022
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• DNA Damage
• Psychological Stress
• Stress, Psychological

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	UPMC Shadyside	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Dana Bovbjerg	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA Stress Response	Change in percent tail intensity will be measured using the Comet assay of DNA damage in blood samples	Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute acute stress task period
Secondary	DNA Stress Response (8-OHdG)	Change in DNA 8-OHdG levels will be measured in blood samples	Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period
Secondary	DNA Stress Response (?-H2AX)	Change in cellular ?-H2AX levels will be measured in blood samples	Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period
Secondary	Neuroendocrine Stress Response (Norepinephrine (NE))	Change in circulating plasma NE levels will be measured in blood samples	Blood samples will be collected after a 60 minute baseline period and during/after the approximately 15 minute task period
Secondary	Neuroendocrine Stress Response (Epinephrine (EPI))	Change in circulating plasma EPI levels will be measured in blood samples	Blood samples will be collected after a 60 minute baseline period and during/after the approximately 15 minute task period
Secondary	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	Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period
Secondary	Cardiovascular Stress Response (Heart rate (HR))	Change in HR will be calculated from repeated assessments	HR will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period
Secondary	Cardiovascular Stress Response (Systolic blood pressure (SBP))	Change in SBP/DBP will be calculated from repeated assessments	Blood pressure will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period
Secondary	Cardiovascular Stress Response (Diastolic blood pressure (DBP))	Change in DBP will be calculated from repeated assessments	Blood pressure will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period
Secondary	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	Anxiety VAS will be administered after a 60 minute baseline period and during/after completion of the tasks
Secondary	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	Stress VAS will be administered after a 60 minute baseline period and during/after completion of the tasks