Back to resultsBrain Effects of Opiate Agonist and Antagonist
Primary Purpose
Chronic Low-back Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Morphine
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Low-back Pain
Eligibility Criteria
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.
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All Participants
Arm Description
People with low back pain who were given and oral dose of 30 mg morphine.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04342130
Brief Title
Brain Effects of Opiate Agonist and Antagonist
Official Title
Brain Effects of Opiate Agonist and Antagonist
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 27, 2018 (Actual)
Primary Completion Date
April 16, 2019 (Actual)
Study Completion Date
April 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All Participants
Arm Type
Experimental
Arm Description
People with low back pain who were given and oral dose of 30 mg morphine.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
30 mg oral tablet
Primary Outcome Measure Information:
Title
Mean Change in Subcortical Brain Structure Volume
Description
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
Title
Change in Brain Response to Highly Caloric Drink
Description
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
Title
Mean Change in Resting Brain Activity in the Nucleus Accumbens
Description
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
Secondary Outcome Measure Information:
Title
Mean Change in Back Pain Intensity
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Geha, MD
Organizational Affiliation
Department of Psychiatry in University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data available from this trial will made available to researcher via reasonable request from the PI.
IPD Sharing Time Frame
study protocol and analytic code will be available after manuscript publication
IPD Sharing Access Criteria
Upon reasonable request from the PI
Learn more about this trial
Brain Effects of Opiate Agonist and Antagonist
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