Effect of Combined Morphine and Duloxetine on Chronic Pain

Last updated: November 8, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Completed

Phase

4

Condition

Chronic Musculoskeletal Pain

Neck Pain

Chronic Pain

Treatment

Duloxetine

Placebo

Morphine

Clinical Study ID

NCT03249558
2017P001589
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 withoutsufficient pain control OR has never taken opioids but has failed at 3 (or more)non-opioid treatments.

Exclusion

Exclusion Criteria:

  1. Subject has major psychiatric disorders requiring recent hospitalization (within 3months) 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 reuptakeinhibitors (SNRI), selective serotonin reuptake inhibitor (SSRI), tricyclicantidepressant.

  6. Subject has a history of suicidal attempts or current suicidal ideation.

  7. Subject takes monoamine oxidase inhibitors, antipsychotics, triptan drugs such assumatriptan, lithium, linezolid, tramadol (Ultram), St. John's Wort, central nervoussystem (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.

Study Design

Total Participants: 81
Treatment Group(s): 3
Primary Treatment: Duloxetine
Phase: 4
Study Start date:
March 12, 2018
Estimated Completion Date:
April 05, 2022

Study Description

Subjects will participate in a 10-week study consisting of three phases: Phase I is the dose titration period of 4 weeks, Phase II is the dose maintenance period of 4 weeks, and Phase III is the dose taper period of 2 weeks. Seven office visits (Initial visit/baseline, weeks 1, 3, 5, 7, 9, and end of week 10) and four follow up phone calls (weeks 2, 4, 6, and 10) will be used to collect data. Since this is a prospective study, we will be able to first determine baseline QST and VAS pain score, followed by assessing their longitudinal changes at each office visit. To assess OIH, QST will be performed at each office visit before subject takes the next dose of the study drugs. We will also measure plasma morphine concentration during the titration and maintenance phase to help validate morphine intake.

Connect with a study center

  • Karina de Sousa

    Boston, Massachusetts 02114
    United States

    Site Not Available

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