Clinical trial NCT03893617: Brief Stresses Experimental Study
Official title: Brief Stresses and DNA Integrity: An Experimental Analysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: DNA Damage
Psychological Stress
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-03-28
Enrollment: 239
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: DNA Stress Response
timeFrame: Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute acute stress task period
Secondary outcomes:
measure: DNA Stress Response (8-OHdG)
timeFrame: Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period
measure: DNA Stress Response (γ-H2AX)
timeFrame: Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period
measure: Neuroendocrine Stress Response (Norepinephrine (NE))
timeFrame: Blood samples will be collected after a 60 minute baseline period and during/after the approximately 15 minute task period
measure: Neuroendocrine Stress Response (Epinephrine (EPI))
timeFrame: Blood samples will be collected after a 60 minute baseline period and during/after the approximately 15 minute task period
measure: Hematological Stress Response
timeFrame: Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period
measure: Cardiovascular Stress Response (Heart rate (HR))
timeFrame: HR will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period
measure: Cardiovascular Stress Response (Systolic blood pressure (SBP))
timeFrame: Blood pressure will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period
measure: Cardiovascular Stress Response (Diastolic blood pressure (DBP))
timeFrame: Blood pressure will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period
measure: Psychological Stress Response (Anxiety Visual Analogue Scale (VAS))
timeFrame: Anxiety VAS will be administered after a 60 minute baseline period and during/after completion of the tasks
measure: Psychological Stress Response (Stress Visual Analogue Scale (VAS))
timeFrame: Stress VAS will be administered after a 60 minute baseline period and during/after completion of the tasks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Shadyside
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Dana Bovbjerg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Frank Jenkins, PhD
role: PRINCIPAL_INVESTIGATOR
References: