NCT04342130

Brain Effects of Opiate Agonist and Antagonist

Completed Phase 4 Results posted Last updated 7 May 2021

What this trial tests

Phase 4 trial testing Morphine in Chronic Low-back Pain in 10 participants. Completed in 16 April 2019.

Timeline

27 April 2018

Primary endpoint
16 April 2019

16 April 2019

Quick facts

Lead sponsor	University of Rochester
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	10
Start date	27 April 2018
Primary completion	16 April 2019
Estimated completion	16 April 2019
Sites	1 location across United States

Drugs / interventions tested

• Morphine

Conditions studied

• Chronic Low-back Pain — all drugs for Chronic Low-back Pain →

Sponsor

University of Rochester

Who can join

Adults 18 to 65, any sex, with Chronic Low-back Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change in Subcortical Brain Structure Volume Primary · 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.

nucleus accumbens

Group	Value	95% CI
30 mg Morphine	0.054	± 0.36

thalamus

Group	Value	95% CI
30 mg Morphine	0.74	± 2.8

amygdala

Group	Value	95% CI
30 mg Morphine	0.27	± 0.38

hippocampus

Group	Value	95% CI
30 mg Morphine	0.48	± 1.4

Change in Brain Response to Highly Caloric Drink Primary · 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 devi

Group	Value	95% CI
30 mg Morphine	4.38

Mean Change in Resting Brain Activity in the Nucleus Accumbens Primary · 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.

Group	Value	95% CI
30 mg Morphine	14.5	± 10.4

Mean Change in Back Pain Intensity Secondary · baseline to 1 hour

Pain was rated using a visual analog scale ranging from 0-100 with 100 indicating the worst imaginable pain ever.

Group	Value	95% CI
30 mg Morphine	3.6	± 1.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 hour. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

30 mg Morphine

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (1 terms — click to expand)

Reaction	System	30 mg Morphine
Itching	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT04342130 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.