A Phase 1 interventional study of Propranolol and Placebo oral capsule in DNA Damage and Psychological Stress, sponsored by Dana Bovbjerg. Terminated at 1 site in United States. Open to participants aged 20 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by Dana Bovbjerg · Phase 1, Interventional, and Basic science
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.
783 studies on the registry are indexed under Stress, Psychological; 128 are open to participants now.
This study's enrollment of 239 is above the median of 85 across 632 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →This is the only study on the registry with Dana Bovbjerg as lead sponsor.
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Exclusion Criteria:
This group will receive a single oral dose (80mg) of propranolol in a blinded capsule during their acute stress study visit.
Drug: Propranolol · Behavioral: Acute stress task · Behavioral: No stress task
This group will receive a single blinded capsule containing no active medication during their acute stress study visit.
Drug: Placebo oral capsule · Behavioral: Acute stress task · Behavioral: No stress task
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.
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.
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.
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.
DNA Stress Response
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
DNA Stress Response (8-OHdG)
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
DNA Stress Response (γ-H2AX)
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
Neuroendocrine Stress Response (Norepinephrine (NE))
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
Neuroendocrine Stress Response (Epinephrine (EPI))
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Stress VAS will be administered after a 60 minute baseline period and during/after completion of the tasks
This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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