Brain Effects of Opiate Agonist and Antagonist
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ClinicalTrials.gov Identifier: NCT04342130 |
Recruitment Status :
Completed
First Posted : April 10, 2020
Results First Posted : May 7, 2021
Last Update Posted : May 7, 2021
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Condition or disease | Intervention/treatment | Phase |
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Chronic Low-back Pain | Drug: Morphine | Phase 4 |
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 |

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

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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.

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 ClinicalTrials.gov identifier (NCT number): NCT04342130
United States, Connecticut | |
Yale University | |
New Haven, Connecticut, United States, 06519 |
Principal Investigator: | Paul Geha, MD | Department of Psychiatry in University of Rochester |
Documents provided by Paul Geha, University of Rochester:
Responsible Party: | Paul Geha, Assistant Professor, University of Rochester |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Low Back Pain Back Pain Pain Neurologic Manifestations Morphine Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |