Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
239 participants
INTERVENTIONAL
2017-10-05
2022-01-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Propranolol group
This group will receive a single oral dose (80mg) of propranolol in a blinded capsule during their acute stress study visit.
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.
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.
Placebo group
This group will receive a single blinded capsule containing no active medication during their 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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
59 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Dana Bovbjerg
OTHER
Responsible Party
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Dana Bovbjerg
Professor
Principal Investigators
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Dana Bovbjerg, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Frank Jenkins, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UPMC Shadyside
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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PRO16080092
Identifier Type: -
Identifier Source: org_study_id
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