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Completed

NCT Number: NCT04342130

Brain Effects of Opiate Agonist and Antagonist

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

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Key information

Conditions

Chronic Low-back Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yale University

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Morphine

Drug

30 mg oral tablet

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 10, 2020
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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