A Phase 4 interventional study of Morphine and Duloxetine in Chronic Low Back Pain and Chronic Neck Pain, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Other
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.
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.
2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
This study's enrollment of 81 is above the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Subjects will take a maximum dose of 60 mg/day of extended release morphine capsules and placebo duloxetine capsules.
Drug: Morphine · Drug: Placebo
Subjects will take placebo morphine capsules and 60 mg of duloxetine capsules.
Drug: Duloxetine · Drug: 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.
Also known as: Morphine Sulfate Contin, Morphine Sulfate Instant Release
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
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
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.
Time frame: 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.
Time frame: 10 weeks
Recruitment goal was not met by the planned completion time.
| Milestone | Morphine, Duloxetine | Morphine, Placebo Duloxetine | Placebo Morphine, Duloxetine |
|---|---|---|---|
| Started | 21 | 19 | 19 |
| Completed | 10 | 12 | 6 |
| Not completed | 11 | 7 | 13 |
| Withdrew: Lost to follow-up | 2 | 1 | 4 |
| Withdrew: Physician decision | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 6 | 5 | 7 |
| Withdrew: Covid-19 pandemic shutdown | 1 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 1 | 2 |
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.
| mg | Morphine, Duloxetine | Morphine, Placebo Duloxetine | Placebo Morphine, Duloxetine |
|---|---|---|---|
| Overall Opioid Dose (Morphine-equivalent Dose in mg) | 19.6 ± 2.05 | 19.6 ± 2.16 | 19.6 ± 2.16 |
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.
| cm | Morphine, Duloxetine | Morphine, Placebo Duloxetine | Placebo Morphine, Duloxetine |
|---|---|---|---|
| Visual Analog Scale (VAS) | 2.8 ± 3.05 | 2.33 ± 3.05 | 4.66 ± 3.05 |
Collected over The adverse events were monitored and assessed through study completion, an average of 6 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Morphine, Duloxetine | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Morphine, Placebo Duloxetine | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Placebo Morphine, Duloxetine | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
81 participants were consented. 22 were deemed ineligible to continue after screening so only 59 were randomized.
| Age, Categorical(Participants) | Morphine, Duloxetine | Morphine, Placebo Duloxetine | Placebo Morphine, Duloxetine | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 16 | 17 | 46 |
| >=65 years | 8 | 3 | 2 | 13 |
| Sex: Female, Male(Participants) | Morphine, Duloxetine | Morphine, Placebo Duloxetine | Placebo Morphine, Duloxetine | Total |
|---|---|---|---|---|
| Female | 7 | 6 | 6 | 19 |
| Male | 14 | 13 | 13 | 40 |
| Ethnicity (NIH/OMB)(Participants) | Morphine, Duloxetine | Morphine, Placebo Duloxetine | Placebo Morphine, Duloxetine | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 4 | 1 | 7 |
| Not Hispanic or Latino | 19 | 15 | 17 | 51 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Morphine, Duloxetine | Morphine, Placebo Duloxetine | Placebo Morphine, Duloxetine | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 6 | 5 | 7 | 18 |
| White | 13 | 10 | 8 | 31 |
| More than one race | 1 | 2 | 1 | 4 |
| Unknown or Not Reported | 1 | 1 | 1 | 3 |
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Massachusetts General Hospital