Beta-Blocker Influences on Inflammatory and Neural Responses to Stress

23-2768

The purpose of this study is to map the neural and molecular mechanisms underlying psychological stress-induced changes in inflammation which could reveal new targets for intervention to reduce the risk of cardiovascular disease.

2024-05-01

2026-05-01

2026-05-01

Recruiting

Early phase I

120

Inclusion Criteria: * Ages 18-30 years * Right-handed * Fluent in English reading, writing, and speaking at least at a 10th grade level * Body mass index (BMI) less than or equal to 35 kg/m\^2 Exclusion Criteria: Assessed as screening, reassessed at Session I: * Non-removeable metal devices/implants/objects in the body * Severe claustrophobia (assessed by self-report) * Currently pregnant * Left-handed * Body mass index (BMI) greater than 35 kg/m\^2 * History of fainting spells or any heart condition * History of or present low resting heart rate (\< 60 BPM) and/or low blood pressure (systolic blood pressure \< 80mmHg) * Self-reported physical illnesses: diabetes, cardiovascular diseases, high blood pressure, inflammatory bowel diseases, rheumatoid arthritis, asthma, autoimmune disease, Crohn's disease, ulcerative colitis, lupus * Any self-reported diagnosed mental illness * Current use of prescription medications * Current or recent regular nicotine/tobacco use (cigarettes, e-cigarettes, vape, chewing tobacco, nicotine gum) * Current regular (daily or almost daily) recreational drug use = 4 or more times per week Instructed against during Session I, reassessed at Session II: * Received any vaccine within the past two weeks * Severe sleep disturbance (3-4 hours of sleep loss) the night before Session II * Vigorous physical activity on the day of Session II * Acute illness or allergy symptoms on the day of Session II * Usage of over-the-counter medications on the day of Session II * Usage of recreational drugs within 48 hours of Session II * Usage of alcohol on the day of Session II

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects (n = 60 per condition, N = 120) will either take a one-time, 40mg dose of propranolol or an encapsulated placebo.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'This is a double blind, randomized, placebo-controlled mechanistic clinical trial. The Investigational Drug Service will randomly assign patients to the experimental group (propranolol) or the placebo group. Research staff who have direct contact with the participant will be blind to their condition.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2024-05-09