Status:
COMPLETED
Effect of Combined Morphine and Duloxetine on Chronic Pain
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Chronic Low Back Pain
Chronic Neck Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
A double-blind, randomized, and placebo-controlled clinical study examining whether duloxetine, a serotonin and norepinephrine reuptake inhibitor (SNRI), could enhance opioid analgesia and reduce over...
Detailed Description
Subjects will participate in a 10-week study consisting of three phases: Phase I is the dose titration period of 4 weeks, Phase II is the dose maintenance period of 4 weeks, and Phase III is the dose ...
Eligibility Criteria
Inclusion
- Subject is 18-70 years old.
- Subject has chronic neck or back pain for at least 3 months.
- Subject has a VAS ≥ 5.
- Has not taken duloxetine in the last 3 months.
- Has not taken an opioid in the last 3 months, but has taken one in the past without sufficient pain control OR has never taken opioids but has failed at 3 (or more) non-opioid treatments.
Exclusion
- Subject has major psychiatric disorders requiring recent hospitalization (within 3 months) such as major depression, bipolar disorder, schizophrenia, anxiety disorder, or psychotic disorder.
- Subject is using illicit drugs detected by urine toxicology/drug screen.
- Subject is pregnant or lactating/breast feeding.
- Subject is allergic to morphine or duloxetine.
- Subject is on an antidepressant including serotonin-norepinephrine reuptake inhibitors (SNRI), selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant.
- Subject has a history of suicidal attempts or current suicidal ideation.
- Subject takes monoamine oxidase inhibitors, antipsychotics, triptan drugs such as sumatriptan, lithium, linezolid, tramadol (Ultram), St. John's Wort, central nervous system (CNS) stimulants such as amphetamine, methylphenidate, methamphetamine, phentermine, diethylpropion, sibutramine, cocaine, or thioridazine.
- Subject has uncontrolled narrow-angle glaucoma.
- Subject has sensory deficits on arms or Raynaud's Syndrome.
- Subject has a pending litigation related to chronic pain condition.
- Subject is on methadone or suboxone treatment for addiction.
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2022
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT03249558
Start Date
March 12 2018
End Date
April 5 2022
Last Update
November 14 2024
Active Locations (1)
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1
Karina de Sousa
Boston, Massachusetts, United States, 02114