Beta-Blocker Influences on Inflammatory and Neural Responses to Stress

NCT ID: NCT06263452

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-05-31

Brief Summary

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.

Detailed Description

The proposed work will conduct a mechanistic clinical trial utilizing the non-selective beta-adrenergic receptor blocker propranolol to examine the role of beta-adrenergic signaling in shaping neural and inflammatory responses to stress. The investigators will focus on beta-adrenergic signaling given seminal pre-clinical work showing that this molecular pathway is an important driver of stress-related increases in inflammation, and initial human neuroimaging work showing that beta-blockade leads to changes in neural responses to negative stimuli. Here, the investigators will bring these two previously disparate lines of work together to determine how experimentally blocking one critical stress-signaling pathway shapes neural activity and inflammatory responses to stress. In doing so, the investigators will be advancing knowledge by mapping mechanisms (i.e., beta-adrenergic signaling), offering methodological improvements (i.e., moving beyond correlation to using pharmacological manipulations to provide causal evidence), and identifying intervention targets (i.e., the neurocognitive systems that shift activity/connectivity in response to beta-blockade). In sum, the work proposed herein is significant because it will address the mechanisms by which one critical risk factor, psychological stress, may ultimately lead to cardiovascular disease via inflammation. The proposed study also offers significant methodological improvements over past work by using neuroimaging to identify neurocognitive pathways, and pharmacology to provide causal experimental evidence to move us beyond correlation. Finally, this project is significant because it could provide insight into novel targets for future interventions.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Propranolol

Propranolol tablet, 40mg, one-time, orally

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

Tablet encapsulated to visually look identical to the placebo.

Placebo

Encapsulated placebo tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Encapsulated sugar pill to visually look identical to the experimental condition.

Interventions

Propranolol

Tablet encapsulated to visually look identical to the placebo.

Intervention Type: DRUG

Placebo

Encapsulated sugar pill to visually look identical to the experimental condition.

Intervention Type: DRUG

Other Intervention Names

Inderal; Propranolol hydrochloride; Sugar pill

Eligibility Criteria

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 (except hormonal contraceptives)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Dartmouth College

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keely Muscatell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Social Neuroscience and Health Laboratory

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jonathan Bunting, BS

Role: CONTACT

jonb@unc.edu

9164957661

Keely A Muscatell, PhD

Role: CONTACT

kmuscatell@unc.edu

9164957661

Facility Contacts

Keely A Muscatell, PhD

Role: primary

kmuscatell@unc.edu

916-495-7661

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Other Identifiers

1R01HL157422-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-2768

Identifier Type: -

Identifier Source: org_study_id