Effect of Combined Morphine and Duloxetine on Chronic Pain

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03249558
Collaborator
(none)
81
1
3
48.8
1.7

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
81 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 :
Mar 12, 2018
Actual Primary Completion Date :
Apr 5, 2022
Actual Study Completion Date :
Apr 5, 2022

Arms and Interventions

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 Names:
  • Morphine Sulfate Contin, Morphine Sulfate Instant Release
  • 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 Names:
  • 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 Names:
  • Morphine Sulfate Contin, Morphine Sulfate Instant Release
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Sugar pill
  • Outcome Measures

    Primary Outcome Measures

    1. Overall Opioid Dose [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) [10 weeks]

      To examine changes in VAS scores and to determine total versus rescue opioid use after each treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karina de Sousa Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    • Principal Investigator: Jianren Mao, MD, PhD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Aug 15, 2017
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, Vice Chair for Research; Chief, Division of Pain Medicine; Director, MGH Center for Translational Pain Research, Massachusetts General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2022