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Effect of Combined Morphine and Duloxetine on Chronic Pain

CompletedPhase 4NCT03249558
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 overall opioid use. Positive outcomes will help improve the overall effectiveness of clinical opioid therapy and reduce unnecessary opioid dose escalation.

Study details

Official title
Effect of Combined Morphine and Duloxetine on Chronic Pain
Sponsor
Massachusetts General Hospital
Start date
2018-03-12
Primary completion
2022-04-05
Sex
All
Age range
from 18 Years to 70 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Subject is 18-70 years old. 2. Subject has chronic neck or back pain for at least 3 months. 3. Subject has a VAS ≥ 5. 4. Has not taken duloxetine in the last 3 months. 5. 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 Criteria: 1. Subject has major psychiatric disorders requiring recent hospitalization (within 3 months) such as major depression, bipolar disorder, schizophrenia, anxiety disorder, or psychotic disorder. 2. Subject is using illicit drugs detected by urine toxicology/drug screen. 3. Subject is pregnant or lactating/breast feeding. 4. Subject is allergic to morphine or duloxetine. 5. Subject is on an antidepressant including serotonin-norepinephrine reuptake inhibitors (SNRI), selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant. 6. Subject has a history of suicidal attempts or current suicidal ideation. 7. 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. 8. Subject has uncontrolled narrow-angle glaucoma. 9. Subject has sensory deficits on arms or Raynaud's Syndrome. 10. Subject has a pending litigation related to chronic pain condition. 11. Subject is on methadone or suboxone treatment for addiction.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03249558