Trial Outcomes & Findings for Does Propranolol Attenuate Inflammatory Responses to a Psychological Stressor? (NCT NCT02972554)
NCT ID: NCT02972554
Last Updated: 2018-12-19
Results Overview
Measured in blood plasma using enzyme-linked immunosorbent assay. Log-transformed prior to analysis to correct for skew in data. Four different change scores were calculated: first, change at post-drug from pre-drug baseline; second, the change at 30-min post-stressor from post-drug baseline; third, change at 60-min post-stressor from post-drug baseline; and fourth, change at 90-min post-stressor from post-drug baseline.
COMPLETED
PHASE4
92 participants
Pre-drug baseline; 60-min post-drug administration baseline before stressor; 30-min post-stressor; 60-min post-stressor; 90-min post-stressor
2018-12-19
Participant Flow
Healthy young adult participants were recruited from campus via flyers and listserv postings. All participants were screened over telephone to ensure they were healthy.
No enrolled participants were excluded from the study before assignment to groups.
Participant milestones
| Measure |
Propanolol Hydrochloride
This is the experimental group given the beta-blocker, propanolol hydrochloride with a single 40mg tablet dosage.
|
Placebo
This is the control group given a placebo, which was a single placebo-matching active drug dose.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
48
|
|
Overall Study
COMPLETED
|
44
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Propranolol Attenuate Inflammatory Responses to a Psychological Stressor?
Baseline characteristics by cohort
| Measure |
Propanolol Hydrochloride
n=44 Participants
This is the experimental group given the beta-blocker, propanolol hydrochloride with a 40mg single tablet dosage.
|
Placebo
n=48 Participants
This is the control group given a placebo, which was a placebo-matching active drug single dosage.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
20.07 Years
STANDARD_DEVIATION 1.28 • n=5 Participants
|
20.49 Years
STANDARD_DEVIATION 1.56 • n=7 Participants
|
20.28 Years
STANDARD_DEVIATION 1.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Interleukin-6 (IL-6)
|
-1.00 log(picograms/mL)
STANDARD_DEVIATION .90 • n=5 Participants
|
-.98 log(picograms/mL)
STANDARD_DEVIATION .86 • n=7 Participants
|
-.99 log(picograms/mL)
STANDARD_DEVIATION .88 • n=5 Participants
|
|
Salivary Cortisol
|
11.51 nanomole/L
STANDARD_DEVIATION 13.04 • n=5 Participants
|
8.62 nanomole/L
STANDARD_DEVIATION 12.05 • n=7 Participants
|
10.07 nanomole/L
STANDARD_DEVIATION 12.55 • n=5 Participants
|
|
Salivary Alpha-Amylase
|
44.68 picograms/mL
STANDARD_DEVIATION 38.85 • n=5 Participants
|
55.13 picograms/mL
STANDARD_DEVIATION 47.17 • n=7 Participants
|
49.91 picograms/mL
STANDARD_DEVIATION 43.01 • n=5 Participants
|
|
Pre-Ejection Period
|
119.97 milliseconds
STANDARD_DEVIATION 18.48 • n=5 Participants
|
116.66 milliseconds
STANDARD_DEVIATION 13.49 • n=7 Participants
|
118.32 milliseconds
STANDARD_DEVIATION 15.99 • n=5 Participants
|
|
Respiratory Sinus Arrhythmia
|
6.86 ratio
STANDARD_DEVIATION 1.18 • n=5 Participants
|
7.02 ratio
STANDARD_DEVIATION 1.02 • n=7 Participants
|
6.94 ratio
STANDARD_DEVIATION 1.10 • n=5 Participants
|
|
Negative, High Arousal Emotion
|
1.20 scores on a scale
STANDARD_DEVIATION .19 • n=5 Participants
|
1.25 scores on a scale
STANDARD_DEVIATION .33 • n=7 Participants
|
1.23 scores on a scale
STANDARD_DEVIATION .26 • n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-drug baseline; 60-min post-drug administration baseline before stressor; 30-min post-stressor; 60-min post-stressor; 90-min post-stressorMeasured in blood plasma using enzyme-linked immunosorbent assay. Log-transformed prior to analysis to correct for skew in data. Four different change scores were calculated: first, change at post-drug from pre-drug baseline; second, the change at 30-min post-stressor from post-drug baseline; third, change at 60-min post-stressor from post-drug baseline; and fourth, change at 90-min post-stressor from post-drug baseline.
Outcome measures
| Measure |
Propanolol Hydrochloride
n=44 Participants
This is the experimental group given the beta-blocker, propanolol hydrochloride using a 40mg single tablet dosage.
|
Placebo
n=48 Participants
This is the control group given a placebo, which was a placebo-matching active drug
|
|---|---|---|
|
Change in Interleukin-6 (IL-6)
Post-drug from pre-drug baseline
|
.05 log(picograms/mL)
Interval -0.126 to 0.226
|
.16 log(picograms/mL)
Interval -0.075 to 0.395
|
|
Change in Interleukin-6 (IL-6)
30-min post-stress from post-drug baseline
|
.31 log(picograms/mL)
Interval 0.016 to 0.604
|
.24 log(picograms/mL)
Interval 0.044 to 0.436
|
|
Change in Interleukin-6 (IL-6)
60-min post-stress from post-drug baseline
|
.32 log(picograms/mL)
Interval 0.006 to 0.634
|
.19 log(picograms/mL)
Interval 0.014 to 0.366
|
|
Change in Interleukin-6 (IL-6)
90-min post-stress from post-drug baseline
|
.48 log(picograms/mL)
Interval 0.206 to 0.754
|
.46 log(picograms/mL)
Interval 0.264 to 0.656
|
SECONDARY outcome
Timeframe: Pre-drug baseline; 60-min post-drug administration baseline before stressor; 15-min post-stressor; 30-min post-stressorConcentration of cortisol in saliva quantified quantified by chemiluminescence immunoassay with high sensitivity. Three different change scores were calculated from pre-drug to post-drug baselines, 15-min post-stressor from post-drug baseline, and 30-min post-stressor from post-drug baseline.
Outcome measures
| Measure |
Propanolol Hydrochloride
n=44 Participants
This is the experimental group given the beta-blocker, propanolol hydrochloride using a 40mg single tablet dosage.
|
Placebo
n=48 Participants
This is the control group given a placebo, which was a placebo-matching active drug
|
|---|---|---|
|
Change in Salivary Cortisol
Post-drug from pre-drug baseline
|
-6.42 nanomole/L
Interval -8.576 to -4.264
|
-3.76 nanomole/L
Interval -5.524 to -1.996
|
|
Change in Salivary Cortisol
15-min post-stress from post-drug baseline
|
5.61 nanomole/L
Interval 3.258 to 7.962
|
4.02 nanomole/L
Interval 2.785 to 5.255
|
|
Change in Salivary Cortisol
30-min post-stress from post-drug baseline
|
2.1 nanomole/L
Interval 0.179 to 4.021
|
1.86 nanomole/L
Interval 0.978 to 2.742
|
SECONDARY outcome
Timeframe: Pre-drug baseline; 60-min post-drug administration baseline before stressor; 15-min post-stressorConcentration of alpha amylase in saliva quantified quantified by enzyme kinetic method. Two different change scores were calculated: first, the pre-drug to post-drug baseline change and, second, the 15-min post-stressor change from post-drug baseline.
Outcome measures
| Measure |
Propanolol Hydrochloride
n=44 Participants
This is the experimental group given the beta-blocker, propanolol hydrochloride using a 40mg single tablet dosage.
|
Placebo
n=48 Participants
This is the control group given a placebo, which was a placebo-matching active drug
|
|---|---|---|
|
Change in Salivary Alpha Amylase
Post-drug from pre-drug baseline
|
-7.50 picograms / mL
Interval -19.299 to 4.299
|
-6.36 picograms / mL
Interval -16.787 to 4.067
|
|
Change in Salivary Alpha Amylase
15-min post-stress from post-drug baseline
|
-15.68 picograms / mL
Interval -26.725 to -4.635
|
6.73 picograms / mL
Interval -3.305 to 16.765
|
SECONDARY outcome
Timeframe: Pre-drug baseline; 60-min post-drug administration baseline before stressor; 2-min before the stressor; 15-min during stressor, 7-min recovery post-stressorMean level pre-ejection period (PEP; centered at zero) derived from impedance cardiography and electrocardiogram. Four different change scores were calculated: first, the change in average PEP from the 5-min pre-drug baseline to the 5-min post-drug baselines; second, the change in average PEP that occurred during the 2-min anticipatory stress speech preparation phase of the Trier Social Stress Test (TSST) from the post-drug baseline; third, the change in average PEP that occurred across the 15-min of the TSST (speech + math tasks) from the post-drug baseline; fourth and finally, the change in average PEP that occurred across 7-min in a post-stressor recovery period as compared to the post-drug baseline.
Outcome measures
| Measure |
Propanolol Hydrochloride
n=44 Participants
This is the experimental group given the beta-blocker, propanolol hydrochloride using a 40mg single tablet dosage.
|
Placebo
n=48 Participants
This is the control group given a placebo, which was a placebo-matching active drug
|
|---|---|---|
|
Change in Pre-Ejection Period
Post-drug from pre-drug baseline
|
7.14 milliseconds
Interval 1.711 to 12.569
|
.86 milliseconds
Interval -3.148 to 4.868
|
|
Change in Pre-Ejection Period
TSST-prep from post-drug baseline
|
-5.33 milliseconds
Interval -9.828 to -0.832
|
-10.92 milliseconds
Interval -14.859 to -6.98
|
|
Change in Pre-Ejection Period
TSST from post-drug baseline
|
-.80 milliseconds
Interval -6.259 to 4.659
|
-10.69 milliseconds
Interval -14.816 to -6.564
|
|
Change in Pre-Ejection Period
Post-stress recovery from post-drug baseline
|
.21 milliseconds
Interval -4.063 to 4.483
|
-1.19 milliseconds
Interval -5.12 to 2.74
|
SECONDARY outcome
Timeframe: Pre-drug baseline; 60-min post-drug administration baseline before stressor; 2-min before the stressor; 15-min during stressor, 7-min recovery post-stressorMean level respiratory sinus arrhythmia (RSA) derived from electrocardiogram; measure of heart rate variability assessed as the ratio of low-to-high frequencies in the respiratory-cardiac power spectrum. Four different change scores were calculated: first, the change in average RSA from the 5-min pre-drug baseline to the 5-min post-drug baselines; second, the change in average RSA that occurred during the 2-min anticipatory stress speech preparation phase of the Trier Social Stress Test (TSST) from the post-drug baseline; third, the change in average RSA that occurred across the 15-min of the TSST (speech + math tasks) from the post-drug baseline; fourth and finally, the change in average RSA that occurred across 7-min in a post-stressor recovery period as compared to the post-drug baseline.
Outcome measures
| Measure |
Propanolol Hydrochloride
n=44 Participants
This is the experimental group given the beta-blocker, propanolol hydrochloride using a 40mg single tablet dosage.
|
Placebo
n=48 Participants
This is the control group given a placebo, which was a placebo-matching active drug
|
|---|---|---|
|
Change in Respiratory Sinus Arrhythmia
Post-drug from pre-drug baseline
|
.11 Ratio
Interval -0.173 to 0.395
|
.27 Ratio
Interval -0.025 to 0.563
|
|
Change in Respiratory Sinus Arrhythmia
TSST-prep from post-drug baseline
|
.36 Ratio
Interval 0.076 to 0.644
|
-.43 Ratio
Interval -0.734 to -0.126
|
|
Change in Respiratory Sinus Arrhythmia
TSST from post-drug baseline
|
-.06 Ratio
Interval -0.332 to 0.212
|
-.87 Ratio
Interval -1.2 to -0.54
|
|
Change in Respiratory Sinus Arrhythmia
Post-stress recovery from post-drug baseline
|
.36 Ratio
Interval 0.088 to 0.632
|
-.26 Ratio
Interval -0.593 to 0.073
|
SECONDARY outcome
Timeframe: Pre-drug baseline; 60-min post-drug administration baseline before stressor; 2-min before the stressor; 1-min post-stressorSelf-report measure of affect (emotion) state using the Positive \& Negative Affect Schedule Negative Affect (PANAS). Answered on a Likert scale from 0 ("not at all") - 6 ("very much"). Mean score range is from 0-6. Higher numbers indicate more negative, high arousal emotions; low numbers indicate less negative, high arousal emotions. Three change scores were calculated from the four different rating measurement time points: a change in negative, high arousal emotions at the post-drug baseline from the pre-drug baseline; a change in emotions right before the Trier Social Stress Task (TSST) from the post-drug baseline; and a change in emotions during the TSST from the post-drug baseline.
Outcome measures
| Measure |
Propanolol Hydrochloride
n=44 Participants
This is the experimental group given the beta-blocker, propanolol hydrochloride using a 40mg single tablet dosage.
|
Placebo
n=48 Participants
This is the control group given a placebo, which was a placebo-matching active drug
|
|---|---|---|
|
Change in Negative, High Arousal Emotion
Post-drug from pre-drug baseline
|
-.10 score on a scale
Interval -0.141 to -0.059
|
-.13 score on a scale
Interval -0.185 to -0.075
|
|
Change in Negative, High Arousal Emotion
TSST-prep from post-drug baseline
|
.18 score on a scale
Interval 0.122 to 0.238
|
.37 score on a scale
Interval 0.3 to 0.44
|
|
Change in Negative, High Arousal Emotion
TSST stressor from post-drug baseline
|
.61 score on a scale
Interval 0.532 to 0.689
|
.76 score on a scale
Interval 0.678 to 0.842
|
Adverse Events
Propanolol Hydrochloride
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Keely A. Muscatell
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place