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Opiate Modulation of Feeding

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

Tracking Information
First Submitted Date  ICMJE April 8, 2020
First Posted Date  ICMJE April 10, 2020
Last Update Posted Date April 13, 2020
Actual Study Start Date  ICMJE April 27, 2018
Actual Primary Completion Date April 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Opiate Modulation of Feeding
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Chronic Low-back Pain
Intervention  ICMJE Drug: Morphine
30 mg oral tablet
Study Arms  ICMJE Experimental: All Participants
People with low back pain who were given and oral dose of 30 mg morphine.
Intervention: Drug: Morphine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2020)
9
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 16, 2019
Actual Primary Completion Date April 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04342130
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE University of Rochester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Geha, MD Department of Psychiatry in University of Rochester
PRS Account University of Rochester
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP