Trial Outcomes & Findings for Brain Effects of Opiate Agonist and Antagonist (NCT NCT04342130)
NCT ID: NCT04342130
Last Updated: 2021-05-07
Results Overview
Magnetic Resonance Imaging (MRI) scanning was performed to collect brain volume measurements in cc. There were 4 different areas of the brain that were analyzed.
COMPLETED
PHASE4
10 participants
baseline to 1 hour
2021-05-07
Participant Flow
Participant milestones
| Measure |
30 mg Morphine
People with low back pain who were given and oral dose of 30 mg morphine.
Morphine: 30 mg oral tablet
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brain Effects of Opiate Agonist and Antagonist
Baseline characteristics by cohort
| Measure |
30 mg Morphine
n=10 Participants
People with low back pain who were given and oral dose of 30 mg morphine.
Morphine: 30 mg oral tablet
|
|---|---|
|
Age, Continuous
|
33.7 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 1 hourPopulation: One participant was missing data for this outcome measure.
Magnetic Resonance Imaging (MRI) scanning was performed to collect brain volume measurements in cc. There were 4 different areas of the brain that were analyzed.
Outcome measures
| Measure |
30 mg Morphine
n=9 Participants
People with low back pain who were given and oral dose of 30 mg morphine.
Morphine: 30 mg oral tablet
|
|---|---|
|
Mean Change in Subcortical Brain Structure Volume
nucleus accumbens
|
0.054 cubic centimeters
Standard Deviation 0.36
|
|
Mean Change in Subcortical Brain Structure Volume
thalamus
|
0.74 cubic centimeters
Standard Deviation 2.8
|
|
Mean Change in Subcortical Brain Structure Volume
amygdala
|
0.27 cubic centimeters
Standard Deviation 0.38
|
|
Mean Change in Subcortical Brain Structure Volume
hippocampus
|
0.48 cubic centimeters
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: baseline to 1 hourParticipants received a highly caloric drink and a tasteless solution during a functional MRI scanning session. A general linear model was used to generate the magnitude of the fit for each type of stimuli and differences between the fits were calculated. A within subject analysis approach was used to calculate the effect of an acute dose of morphine on brain response to the highly caloric drink. Participants contributed beta values that were averaged across subjects and based on the average and standard deviation, the software, FSL, calculated Z = 4.38. This value indicates 4.38 standard deviations away from the mean in a distribution with a mean of zero and standard deviation of 1, which is the definition of the Gaussian curve (Z-distribution). It is scientifically not valid to say there is a higher or lower brain response. A Z-score = 0 means no change from baseline in brain response; a Z-score different from zero indicates a change from baseline after the ingestion of morphine.
Outcome measures
| Measure |
30 mg Morphine
n=10 Participants
People with low back pain who were given and oral dose of 30 mg morphine.
Morphine: 30 mg oral tablet
|
|---|---|
|
Change in Brain Response to Highly Caloric Drink
|
4.38 z-score
|
PRIMARY outcome
Timeframe: baseline to 1 hourPopulation: Data was missing for one participant for this outcome measure.
Participants were scanned at rest during a functional MRI session. The resting brain activity was measured as the Power spectral density slow-4 frequency band. Data collected in the frequency range 0 and 0.5 Hertz was analyzed. We examined the power spectral density in the range of 0.027 to 0.073 Hertz. The mean change is expressed as arbitrary units after a Fourier transformation of the data which cancels out the units. The mean change ranges from 0 to 175. The higher the number the more energy within that frequency band.
Outcome measures
| Measure |
30 mg Morphine
n=9 Participants
People with low back pain who were given and oral dose of 30 mg morphine.
Morphine: 30 mg oral tablet
|
|---|---|
|
Mean Change in Resting Brain Activity in the Nucleus Accumbens
|
14.5 units on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: baseline to 1 hourPopulation: Back pain data was missing for one participant.
Pain was rated using a visual analog scale ranging from 0-100 with 100 indicating the worst imaginable pain ever.
Outcome measures
| Measure |
30 mg Morphine
n=9 Participants
People with low back pain who were given and oral dose of 30 mg morphine.
Morphine: 30 mg oral tablet
|
|---|---|
|
Mean Change in Back Pain Intensity
|
3.6 units on a scale
Standard Deviation 1.7
|
Adverse Events
30 mg Morphine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
30 mg Morphine
n=10 participants at risk
People with low back pain who were given and oral dose of 30 mg morphine.
Morphine: 30 mg oral tablet
|
|---|---|
|
Skin and subcutaneous tissue disorders
Itching
|
10.0%
1/10 • 1 hour
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place