Effect of Combined Morphine and Duloxetine on Chronic Pain

Chronic Low Back Pain Clinical Trial

— Duloxetine  

Official title:

Effect of Combined Morphine and Duloxetine on Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249558
• Other study ID #: 2017P001589
• Status: Completed
• Phase: Phase 4
• Start date: March 12, 2018
• Est. completion date: April 5, 2022

Study information

• Verified date: August 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 5, 2022
• Est. primary completion date: April 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Low Back Pain
• Chronic Neck Pain
• Chronic Pain
• Low Back Pain
• Neck Pain

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Karina de Sousa	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 weeks
Primary	Visual Analog Scale (VAS)	To examine changes in VAS scores and to determine total versus rescue opioid use after each treatment	10 weeks