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

Primary Purpose

Chronic Low Back Pain, Chronic Neck Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Morphine
Duloxetine
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Low Back Pain focused on measuring Pain, Pain Management

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Karina de Sousa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Morphine, Duloxetine

Morphine, Placebo Duloxetine

Placebo Morphine, Duloxetine

Arm Description

Subjects will take a maximum dose of 60 mg/day of extended release morphine capsules and 60 mg of duloxetine capsules.

Subjects will take a maximum dose of 60 mg/day of extended release morphine capsules and placebo duloxetine capsules.

Subjects will take placebo morphine capsules and 60 mg of duloxetine capsules.

Outcomes

Primary Outcome Measures

Overall Opioid Dose
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.
Visual Analog Scale (VAS)
To examine changes in VAS scores and to determine total versus rescue opioid use after each treatment

Secondary Outcome Measures

Full Information

First Posted
August 11, 2017
Last Updated
August 23, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03249558
Brief Title
Effect of Combined Morphine and Duloxetine on Chronic Pain
Acronym
Duloxetine
Official Title
Effect of Combined Morphine and Duloxetine on Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
April 5, 2022 (Actual)
Study Completion Date
April 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Chronic Neck Pain
Keywords
Pain, Pain Management

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morphine, Duloxetine
Arm Type
Active Comparator
Arm Description
Subjects will take a maximum dose of 60 mg/day of extended release morphine capsules and 60 mg of duloxetine capsules.
Arm Title
Morphine, Placebo Duloxetine
Arm Type
Placebo Comparator
Arm Description
Subjects will take a maximum dose of 60 mg/day of extended release morphine capsules and placebo duloxetine capsules.
Arm Title
Placebo Morphine, Duloxetine
Arm Type
Placebo Comparator
Arm Description
Subjects will take placebo morphine capsules and 60 mg of duloxetine capsules.
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Morphine Sulfate Contin, Morphine Sulfate Instant Release
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Opioid Dose
Description
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.
Time Frame
10 weeks
Title
Visual Analog Scale (VAS)
Description
To examine changes in VAS scores and to determine total versus rescue opioid use after each treatment
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianren Mao, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karina de Sousa
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Combined Morphine and Duloxetine on Chronic Pain

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