Clinical trial

Brief Stresses and DNA Integrity: An Experimental Analysis

Name

PRO16080092

Description

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.

Trial arms

Trial start

2017-10-05

Estimated PCD

2022-01-27

Trial end

2022-01-27

Status

Terminated

Phase

Early phase I

Treatment

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.

Arms:

Propranolol group

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.

Arms:

Placebo group

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.

Arms:

Placebo group, Propranolol group

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.

Arms:

Placebo group, Propranolol group

Size

239

Primary endpoint

DNA Stress Response

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

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 239, 'type': 'ACTUAL'}}

Updated at

2023-07-18

1 organization

2 products

2 indications

Organization

Product

Indication

Indication

Product