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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA211371 | U.S. NIH Grant/Contract | View source |
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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.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propranolol group | Active Comparator | This group will receive a single oral dose (80mg) of propranolol in a blinded capsule during their acute stress study visit. |
|
| Placebo group | Placebo Comparator | This group will receive a single blinded capsule containing no active medication during their acute stress study visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| DNA Stress Response (γ-H2AX) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana Bovbjerg, PhD | University of Pittsburgh | Principal Investigator |
| Frank Jenkins, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Shadyside | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Placebo oral capsule | Drug | 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. |
|
| Acute stress task | Behavioral | 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 | Behavioral | 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. |
|
Change in cellular γ-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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |