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Brain Effects of Opiate Agonist and Antagonist

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04342130
Recruitment Status : Completed
First Posted : April 10, 2020
Results First Posted : May 7, 2021
Last Update Posted : May 7, 2021
Information provided by (Responsible Party):
Paul Geha, University of Rochester

Brief Summary:
This study will look at the short-term effect of morphine on brain response to food.

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Drug: Morphine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Brain Effects of Opiate Agonist and Antagonist
Actual Study Start Date : April 27, 2018
Actual Primary Completion Date : April 16, 2019
Actual Study Completion Date : April 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: All Participants
People with low back pain who were given and oral dose of 30 mg morphine.
Drug: Morphine
30 mg oral tablet

Primary Outcome Measures :
  1. Mean Change in Subcortical Brain Structure Volume [ Time Frame: 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.

  2. Change in Brain Response to Highly Caloric Drink [ Time Frame: 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.

  3. Mean Change in Resting Brain Activity in the Nucleus Accumbens [ Time Frame: 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 Outcome Measures :
  1. Mean Change in Back Pain Intensity [ Time Frame: baseline to 1 hour ]
    Pain was rated using a visual analog scale ranging from 0-100 with 100 indicating the worst imaginable pain ever.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04342130

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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
University of Rochester
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Principal Investigator: Paul Geha, MD Department of Psychiatry in University of Rochester
  Study Documents (Full-Text)

Documents provided by Paul Geha, University of Rochester:
Informed Consent Form  [PDF] August 7, 2018

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Responsible Party: Paul Geha, Assistant Professor, University of Rochester Identifier: NCT04342130    
Other Study ID Numbers: YaleIRB#1607018141
First Posted: April 10, 2020    Key Record Dates
Results First Posted: May 7, 2021
Last Update Posted: May 7, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data available from this trial will made available to researcher via reasonable request from the PI.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: study protocol and analytic code will be available after manuscript publication
Access Criteria: Upon reasonable request from the PI

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Low Back Pain
Back Pain
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents