Brief Stresses Experimental Study

NCT03893617 | Terminated Phase 1 FDA Drug

• 2 other identifiers: PRO16080092R01CA211371
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

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.

Conditions

DNA Damage; Psychological Stress

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• DNA Stress Response (8-OHdG)

  Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period

• DNA Stress Response (γ-H2AX)

  Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period

• Neuroendocrine Stress Response (Norepinephrine (NE))

  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))

  Blood samples will be collected after a 60 minute baseline period and during/after the approximately 15 minute task period

• Hematological Stress Response

  Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period

Study Arms (2)

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.

Drug: Propranolol; Behavioral: Acute stress task; Behavioral: No stress task

Placebo group

PLACEBO COMPARATOR

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

Interventions

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.

Propranolol group

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.

Placebo group

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.

Placebo group; Propranolol group

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.

Placebo group; Propranolol group

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana Bovbjerg: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UPMC Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Dana Bovbjerg, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Frank Jenkins, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: October 5, 2017
• Primary Completion: January 27, 2022
• Study Completion: January 27, 2022
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

US (1)