Clinical trial NCT03249558: Effect of Combined Morphine and Duloxetine on Chronic Pain
Official title: Effect of Combined Morphine and Duloxetine on Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Low Back Pain
Chronic Neck Pain
Keywords: Pain
Pain Management
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Opioid Dose (Morphine-equivalent Dose in mg)
timeFrame: 10 weeks
measure: Visual Analog Scale (VAS)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Karina de Sousa
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jianren Mao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: