Opiate Modulation of Feeding

• ClinicalTrials.gov Identifier: NCT04342130
• Recruitment Status: Completed
• First Posted: April 10, 2020
• Last Update Posted: April 13, 2020
• Sponsor: University of Rochester
• Information provided by (Responsible Party): Paul Geha, University of Rochester

Tracking Information

• First Submitted Date: April 8, 2020
• First Posted Date: April 10, 2020
• Last Update Posted Date: April 13, 2020
• Actual Study Start Date: April 27, 2018
• Actual Primary Completion Date: April 16, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 9, 2020)

• 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.
• Mean 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. General linear model was used to generate the magnitude of the fit for each type of stimuli and differences between the fits were calculated. Next within subject analysis approach was used to calculate the effect of an acute dose of morphine on brain response to the highly caloric drink between baseline and 1 hour. The measures of the fit and their differences are expressed in z-scores.
• mean change in resting brain activity [ Time Frame: baseline to 1 hour ]
  Participants were scanned at rest during a functional MRI session.

Original Primary Outcome Measures (submitted: April 8, 2020)

• 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.
• Mean Change in Brain Response to Highly Caloric Drink [ Time Frame: baseline to 1 hour ]
  Participants were given a highly caloric drink during a functional magnetic resonance imaging procedure. The brain response was defined a brain activation and the magnitude of the fit between time course of milkshake delivery and brain activity.
• mean change in resting brain activity [ Time Frame: baseline to 1 hour ]
  Participants were scanned at rest during a functional MRI session.

Current Secondary Outcome Measures (submitted: April 8, 2020)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Opiate Modulation of Feeding
• Official Title: Opiate Modulation of Feeding
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Chronic Low-back Pain

Intervention

Drug: Morphine

30 mg oral tablet

Study Arms

Experimental: All Participants

People with low back pain who were given and oral dose of 30 mg morphine.

Intervention: Drug: Morphine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 8, 2020): 9
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 16, 2019
• Actual Primary Completion Date: April 16, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04342130
• Other Study ID Numbers: YaleIRB#1607018141
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: 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

• Responsible Party: Paul Geha, University of Rochester
• Study Sponsor: University of Rochester
• Collaborators: Not Provided

Investigators

• Principal Investigator: Paul Geha, MD; Department of Psychiatry in University of Rochester

• PRS Account: University of Rochester
• Verification Date: April 2020