Brief Stresses Experimental Study

Dana Bovbjerg

Status and phase: Terminated; Phase 1

Conditions: Psychological Stress; DNA Damage

Treatments: Drug: Propranolol; Behavioral: No stress task; Drug: Placebo oral capsule; Behavioral: Acute stress task

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03893617

PRO16080092

R01CA211371 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 239 patients

Sex: All

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

239 participants in 2 patient groups, including a placebo group

Propranolol group

Active Comparator group

Description:

This group will receive a single oral dose (80mg) of propranolol in a blinded capsule during their acute stress study visit.

Treatment:

Drug: Propranolol

Behavioral: Acute stress task

Behavioral: No stress task

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral capsule

Behavioral: Acute stress task

Behavioral: No stress task