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Effect of Combined Morphine and Duloxetine on Chronic Pain (Duloxetine)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249558
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Chronic Neck Pain Drug: Morphine Drug: Duloxetine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Effect of Combined Morphine and Duloxetine on Chronic Pain
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: Morphine, Duloxetine
Subjects will take a maximum dose of 60 mg/day of extended release morphine capsules and 60 mg of duloxetine capsules.
Drug: Morphine
Subjects will be randomized into one of the treatment groups and will follow the assigned medication schedule for 10 weeks. Quantitative Sensory Testing (QST) will be performed on the subjects to compare pain threshold, pain tolerance, and wind up.
Other Name: MS Contin, MS IR

Drug: Duloxetine
Subjects will be randomized into one of the treatment groups and will follow the assigned medication schedule for 10 weeks. Quantitative Sensory Testing (QST) will be performed on the subjects to compare pain threshold, pain tolerance, and wind up.
Other Name: Cymbalta

Placebo Comparator: Morphine, Placebo Duloxetine
Subjects will take a maximum dose of 60 mg/day of extended release morphine capsules and placebo duloxetine capsules.
Drug: Morphine
Subjects will be randomized into one of the treatment groups and will follow the assigned medication schedule for 10 weeks. Quantitative Sensory Testing (QST) will be performed on the subjects to compare pain threshold, pain tolerance, and wind up.
Other Name: MS Contin, MS IR

Drug: Placebo
Subjects will be randomized into one of the treatment groups and will follow the assigned medication schedule for 10 weeks. Quantitative Sensory Testing (QST) will be performed on the subjects to compare pain threshold, pain tolerance, and wind up.
Other Name: Sugar pill

Placebo Comparator: Placebo Morphine, Duloxetine
Subjects will take placebo morphine capsules and 60 mg of duloxetine capsules.
Drug: Duloxetine
Subjects will be randomized into one of the treatment groups and will follow the assigned medication schedule for 10 weeks. Quantitative Sensory Testing (QST) will be performed on the subjects to compare pain threshold, pain tolerance, and wind up.
Other Name: Cymbalta

Drug: Placebo
Subjects will be randomized into one of the treatment groups and will follow the assigned medication schedule for 10 weeks. Quantitative Sensory Testing (QST) will be performed on the subjects to compare pain threshold, pain tolerance, and wind up.
Other Name: Sugar pill




Primary Outcome Measures :
  1. Overall Opioid Dose [ Time Frame: 10 weeks ]
    The investigators will compare overall opioid dose between the morphine/duloxetine group and the morphine/placebo group and compare rescue dose among all three groups.

  2. Visual Analog Scale (VAS) [ Time Frame: 10 weeks ]
    To examine changes in VAS scores and to determine total versus rescue opioid use after each treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249558


Contacts
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Contact: Karina de Sousa, BS 617-724-6102 kdesousa1@mgh.harvard.edu
Contact: Grace Mogren, BS 617-724-6102 gmogren@mgh.harvard.edu

Locations
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United States, Massachusetts
Karina de Sousa Recruiting
Boston, Massachusetts, United States, 02114
Contact: Karina de Sousa, BS    617-724-6102    kdesousa1@mgh.harvard.edu   
Contact: Grace Mogren, BS    617-724-6012    gmogren@mgh.harvard.edu   
Principal Investigator: Jianren Mao, M.D., Ph.D.         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Jianren Mao, MD, PhD Massachusetts General Hospital
Additional Information:
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Responsible Party: Jianren Mao, MD, PhD, Vice Chair for Research; Chief, Division of Pain Medicine; Director, MGH Center for Translational Pain Research, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03249558    
Other Study ID Numbers: 2017P001589
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jianren Mao, MD, PhD, Massachusetts General Hospital:
Pain
Pain Management
Additional relevant MeSH terms:
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Low Back Pain
Chronic Pain
Neck Pain
Back Pain
Pain
Neurologic Manifestations
Morphine
Duloxetine Hydrochloride
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents