Effect of Combined Morphine and Duloxetine on Chronic Pain

NCT03249558 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2017P001589
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain; Chronic Neck Pain

Keywords

Pain; Pain Management

Outcome Measures

Primary Outcomes (2)

• Overall Opioid Dose (Morphine-equivalent Dose in mg)

  The investigators will compare overall opioid dose (in morphine-equivalent dose in mg) between the morphine/duloxetine group and the morphine/placebo group and compare rescue dose among all three groups. The higher overall opioid dose, the more consumption of opioid.

  10 weeks

• Visual Analog Scale (VAS)

  To examine changes in pain intensity measured on a Visual Analog Scale with units on a scale ranging from 0 cm-10 cm (0 cm being lowest and 10 cm being the higher the score, where values closer to 10 cm reflect more pain) and to determine total versus rescue opioid use after each treatment.

  10 weeks

Study Arms (3)

Morphine, Duloxetine

ACTIVE COMPARATOR

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

Drug: Morphine; Drug: Duloxetine

Morphine, Placebo Duloxetine

PLACEBO COMPARATOR

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

Drug: Morphine; Drug: Placebo

Placebo Morphine, Duloxetine

PLACEBO COMPARATOR

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

Drug: Duloxetine; Drug: Placebo

Interventions

Morphine DRUG

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.

Also known as: Morphine Sulfate Contin, Morphine Sulfate Instant Release

Morphine, Duloxetine; Morphine, Placebo Duloxetine

Duloxetine DRUG

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.

Also known as: Cymbalta

Morphine, Duloxetine; Placebo Morphine, Duloxetine

Placebo DRUG

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.

Also known as: Sugar pill

Morphine, Placebo Duloxetine; Placebo Morphine, Duloxetine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Karina de Sousa

Boston, Massachusetts, 02114, United States

Location

Related Links

• Massachusetts General Hospital Center for Translational Pain Research

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Morphine; Duloxetine Hydrochloride; Sugars

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Carbohydrates

Limitations and Caveats

In this study we did not enroll enough participants to reach the number needed for our analysis to have power which is a limitation.

Results Point of Contact

• Title: Dr. Jianren Mao
• Organization: Massachusetts General Hospital

mghpainresearch@partners.org

617-724-6102

Study Officials

• Jianren Mao, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair for Research; Chief, Division of Pain Medicine; Director, MGH Center for Translational Pain Research

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 15, 2017
• Study Start: March 12, 2018
• Primary Completion: April 5, 2022
• Study Completion: April 5, 2022
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)