Beta-Blocker Influences on Inflammatory and Neural Responses to Stress

NCT06263452 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 23-27681R01HL157422-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

Beta-Blockade; Inflammation; Neuroimaging

Outcome Measures

Primary Outcomes (2)

• Change in levels of pro-inflammatory cytokine interleukin-6 in response to social stress

  Blood plasma will be analyzed for levels of pro-inflammatory cytokine interleukin-6 (IL-6), from baseline, a baseline after drug administration, a sample 90-minutes after the stress task (T-90) measured in pg/mL. The timeline was determined on meta-analytic work showing changes in the inflammatory cytokine IL-6 are largest at 90 minutes post-stress.

  Post-drug baseline to 90-minutes post-stress task (T-90)

• Change in levels of inflammatory gene expression in response to social stress

  Whole blood samples will be collected in PaxGene tubes and analyzed for changes in inflammatory gene expression from baseline, a baseline after drug administration, and 30-minutes after the stress task (T-30), measured in gene transcript counts per million. The timeline is based on the Principal Investigator's work showing that changes in pro-inflammatory gene expression are observed 30-minutes post-stress.

  Post-drug baseline to 30-minutes post-stress task (T-30)

Study Arms (2)

Propranolol

EXPERIMENTAL

Propranolol tablet, 40mg, one-time, orally

Drug: Propranolol

Placebo

PLACEBO COMPARATOR

Encapsulated placebo tablet

Drug: Placebo

Interventions

Propranolol DRUG

Tablet encapsulated to visually look identical to the placebo.

Also known as: Inderal, Propranolol hydrochloride

Propranolol

Placebo DRUG

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

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of California, Los Angeles: collaborator
• Dartmouth College: collaborator

Study Sites (1)

Social Neuroscience and Health Laboratory

Chapel Hill, North Carolina, 27514, United States

RECRUITING

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MeSH Terms

Conditions

Cardiovascular Diseases; Inflammation

Interventions

Propranolol; Sugars

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Keely Muscatell, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Bunting, BS

CONTACT

9164957661; jonb@unc.edu

Keely A Muscatell, PhD

CONTACT

9164957661; kmuscatell@unc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects (n = 60 per condition, N = 120) will either take a one-time, 40mg dose of propranolol or an encapsulated placebo.

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 16, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)