Brief Stresses Experimental Study

NCT ID: NCT03893617

Last Updated: 2023-07-18

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-05

Study Completion Date

2022-01-27

Brief Summary

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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.

Detailed Description

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Conditions

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DNA Damage Psychological Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Group Type ACTIVE_COMPARATOR

Propranolol

Intervention Type 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.

Acute stress task

Intervention Type 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

Intervention Type 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.

Placebo group

This group will receive a single blinded capsule containing no active medication during their acute stress study visit.

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type 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

Intervention Type 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

Intervention Type 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.

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.

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Dana Bovbjerg

OTHER

Sponsor Role lead

Responsible Party

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Dana Bovbjerg

Professor

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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R01CA211371

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO16080092

Identifier Type: -

Identifier Source: org_study_id

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