Effect of Combined Morphine and Duloxetine on Chronic Pain



Status:Recruiting
Conditions:Back Pain, Back Pain, Chronic Pain, Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 70
Updated:8/18/2018
Start Date:February 1, 2018
End Date:January 2021
Contact:Jianren Mao, MD, PhD
Email:jmao@mgh.harvard.edu
Phone:617-724-6102

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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.


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.
We found this trial at
1
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Boston, Massachusetts 02114
Principal Investigator: Jianren Mao, M.D., Ph.D.
Phone: 617-724-6102
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Boston, MA
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