Chronic Low-back Pain
Conditions
Brief summary
This study will look at the short-term effect of morphine on brain response to food.
Detailed description
Chronic low back pain patients and healthy controls will be recruited for this study. Participants' brain will be scanned at baseline and then again on a different day after the administration of an oral dose of 30 mg morphine in an open label design. Participants will receive morphine 60 minutes prior to the start of the second scanning session. The brain scans will include structural scans, functional scans at rest and functional scans during the ingestion of a highly caloric drink.
Interventions
DRUGMorphine
30 mg oral tablet
Sponsors
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy participants * Patients in pain: suffering from persistent pain more days than not, 3/10 in intensity on a numerical rating scale, for at least 6 weeks or more.
Exclusion criteria
* Any DSM diagnosis * diabetes * food allergies * lactose intolerance * participants seeking to quit smoking or to lose weight * participants on any psychotropic medication including opiate based analgesics (e.g. oxycodone, methadone, suboxone) * pregnant or nursing women * pacemaker or other implanted electrical devices * Participants with a past history of head trauma or seizures * Any past history of illegal drug or alcohol misuse * Participants who cannot undergo an MRI scan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Subcortical Brain Structure Volume | baseline to 1 hour | 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. |
| Change in Brain Response to Highly Caloric Drink | baseline to 1 hour | Participants 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. |
| Mean Change in Resting Brain Activity in the Nucleus Accumbens | baseline to 1 hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Back Pain Intensity | baseline to 1 hour | Pain was rated using a visual analog scale ranging from 0-100 with 100 indicating the worst imaginable pain ever. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 30 mg Morphine People with low back pain who were given and oral dose of 30 mg morphine.
Morphine: 30 mg oral tablet | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | 30 mg Morphine |
|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Change in Brain Response to Highly Caloric Drink
Participants 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.
Time frame: baseline to 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 30 mg Morphine | Change in Brain Response to Highly Caloric Drink | 4.38 z-score |
Primary
Mean Change in Resting Brain Activity in the Nucleus Accumbens
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.
Time frame: baseline to 1 hour
Population: Data was missing for one participant for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 30 mg Morphine | Mean Change in Resting Brain Activity in the Nucleus Accumbens | 14.5 units on a scale | Standard Deviation 10.4 |
Primary
Mean Change in Subcortical Brain Structure Volume
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.
Time frame: baseline to 1 hour
Population: One participant was missing data for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 30 mg Morphine | Mean Change in Subcortical Brain Structure Volume | nucleus accumbens | 0.054 cubic centimeters | Standard Deviation 0.36 |
| 30 mg Morphine | Mean Change in Subcortical Brain Structure Volume | thalamus | 0.74 cubic centimeters | Standard Deviation 2.8 |
| 30 mg Morphine | Mean Change in Subcortical Brain Structure Volume | amygdala | 0.27 cubic centimeters | Standard Deviation 0.38 |
| 30 mg Morphine | Mean Change in Subcortical Brain Structure Volume | hippocampus | 0.48 cubic centimeters | Standard Deviation 1.4 |
p-value: >0.05t-test, 2 sided
Secondary
Mean Change in Back Pain Intensity
Pain was rated using a visual analog scale ranging from 0-100 with 100 indicating the worst imaginable pain ever.
Time frame: baseline to 1 hour
Population: Back pain data was missing for one participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 30 mg Morphine | Mean Change in Back Pain Intensity | 3.6 units on a scale | Standard Deviation 1.7 |