Phase 4
N=10
Brain Effects of Opiate Agonist and Antagonist
Chronic Low-back Pain
Bottom Line
View on ClinicalTrials.gov: NCT04342130 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Mean Change in Subcortical Brain Structure Volume — 0.054; 0.74; 0.27; 0.48 cubic centimeters — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Morphine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Subcortical Brain Structure Volume |
0.054; 0.74; 0.27; 0.48 | >0.05 |
| PRIMARY Change in Brain Response to Highly Caloric Drink |
4.38 | — |
| PRIMARY Mean Change in Resting Brain Activity in the Nucleus Accumbens |
14.5 | — |
| SECONDARY Mean Change in Back Pain Intensity |
3.6 | — |
Summary
This study will look at the short-term effect of morphine on brain response to food.
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.
Data sourced from ClinicalTrials.gov (NCT04342130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.