NCT06263452 · University of North Carolina, Chapel Hill
Beta-Blocker Influences on Inflammatory and Neural Responses to Stress
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Propranolol
Tablet encapsulated to visually look identical to the placebo.
DRUG
Placebo
Encapsulated sugar pill to visually look identical to the experimental condition.
Primary outcome measures
Change in levels of pro-inflammatory cytokine interleukin-6 in response to social stress
Time frame: Post-drug baseline to 90-minutes post-stress task (T-90)
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.
Change in levels of inflammatory gene expression in response to social stress
Time frame: Post-drug baseline to 30-minutes post-stress task (T-30)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chapel Hill, North Carolina
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of California, Los Angeles, Dartmouth College
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 29, 2025 · Source of record for eligibility and locations