Brain Effects of Opiate Agonist and Antagonist

University of Rochester

Status and phase: Completed; Phase 4

Conditions: Chronic Low-back Pain

Treatments: Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT04342130

YaleIRB#1607018141

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

All Participants

Experimental group

Description:

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

Treatment:

Drug: Morphine