Phase 4
N=92
Does Propranolol Attenuate Inflammatory Responses to a Psychological Stressor?
Stress, Psychological · Inflammation · Cortisol · Sympathetic Nervous System
Bottom Line
View on ClinicalTrials.gov: NCT02972554 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Change in Interleukin-6 (IL-6) — .05; .16; .31; .24 log(picograms/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Propanolol hydrochloride (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Interleukin-6 (IL-6) |
.05; .16; .31; .24; .32; .19 | — |
| SECONDARY Change in Salivary Cortisol |
-6.42; -3.76; 5.61; 4.02; 2.1; 1.86 | — |
| SECONDARY Change in Salivary Alpha Amylase |
-7.50; -6.36; -15.68; 6.73 | — |
| SECONDARY Change in Pre-Ejection Period |
7.14; .86; -5.33; -10.92; -.80; -10.69 | — |
| SECONDARY Change in Respiratory Sinus Arrhythmia |
.11; .27; .36; -.43; -.06; -.87 | — |
| SECONDARY Change in Negative, High Arousal Emotion |
-.10; -.13; .18; .37; .61; .76 | — |
Summary
This randomized, double-blind, placebo-controlled study of propranolol will shed important light on how sympathetic nervous system (SNS) activation influences psychological and inflammatory responses to acute stress. Results from this study will inform both the basic science literature that is attempting to map the physiological mechanisms by which psychological stress may lead to poor mental and physical health, and may also ultimately have therapeutic relevance for individuals who are experiencing high levels of stress that is putting their health at risk. Utilizing a psychopharmacological approach allows for the circumvention of many of the challenges of conducting this research in human populations, and will allow for conclusions regarding causality, given that SNS activation will be experimentally manipulated, rather than relying on correlational measures of SNS activity that are difficult to assess and are not appropriate for asking if SNS activity causes changes in psychology and biology.
Eligibility Criteria
Inclusionary Criteria
- Healthy volunteers
- Age 18-25
- Fluent in English
Exclusionary Criteria
- presence or history of chronic physical illness (especially disorders with an inflammatory component, such as rheumatoid arthritis, asthma, allergies, or issues that can affect the heart, including low-blood pressure or other heart conditions)
- presence or history of psychiatric illness (depression, anxiety)
- any current prescription medication use
- currently pregnant or planning to become pregnant
- engagement in a number of health--compromising behaviors that may affect levels of pro-inflammatory cytokines, including cigarette smoking, excessive caffeine intake and sleep disturbance (e.g., working night shifts)
- body mass index (BMI) greater than 30, given that adiposity is known to relate to baseline levels of inflammation
- anxiety about or previous history of problems with blood draws (e.g., fainting)
- any reported heart conditions
- history of fainting spells
- low pulse, as measured at beginning of session I (below 60)
- low blood pressure, as measured at beginning of session I (below 80)
Data sourced from ClinicalTrials.gov (NCT02972554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.