Brain Effects of Opiate Agonist and Antagonist

NCT ID: NCT04342130

Last Updated: 2021-05-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-27

Study Completion Date

2019-04-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Low-back Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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All Participants

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

Group Type EXPERIMENTAL

Morphine

Intervention Type DRUG

30 mg oral tablet

Interventions

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Morphine

30 mg oral tablet

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Paul Geha

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Geha, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry in University of Rochester

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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YaleIRB#1607018141

Identifier Type: -

Identifier Source: org_study_id

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