Chronic Low Back PainPhase 4DuloxetineNCT03249558

Effect of Combined Morphine and Duloxetine on Chronic Pain

A Phase 4 study testing Morphine and Duloxetine in people with Chronic Low Back Pain and Chronic Neck Pain, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Low Back Pain, Chronic Neck Pain
What is being tested?: Morphine and Duloxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 81 participants
Where: 1 siteUnited States
Study dates: 12 Mar 2018to 5 Apr 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is 18-70 years old.
Subject has chronic neck or back pain for at least 3 months.
Subject has a VAS ≥ 5.
Has not taken duloxetine in the last 3 months.
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.

Who cannot join

Subject has major psychiatric disorders requiring recent hospitalization (within 3 months) such as major depression, bipolar disorder, schizophrenia, anxiety disorder, or psychotic disorder.
Subject is using illicit drugs detected by urine toxicology/drug screen.
Subject is pregnant or lactating/breast feeding.
Subject is allergic to morphine or duloxetine.
Subject is on an antidepressant including serotonin-norepinephrine reuptake inhibitors (SNRI), selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant.
Subject has a history of suicidal attempts or current suicidal ideation.

Show all 11Show fewer

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.
Subject has uncontrolled narrow-angle glaucoma.
Subject has sensory deficits on arms or Raynaud's Syndrome.
Subject has a pending litigation related to chronic pain condition.
Subject is on methadone or suboxone treatment for addiction.

Trial locations and contacts

1 site in 1 country.

United States1 site

Karina de Sousa
Boston, Massachusetts, 02114

Other trials in United States

About this study

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.

Read the 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.

Conditions: Chronic Low Back Pain, Chronic Neck Pain
Being tested: Morphine, Duloxetine, Placebo
Keywords: Pain, Pain Management
Medical subject headings: Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MorphineDrug
Also called 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.
DuloxetineDrug
Also called 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.
PlaceboDrug
Also called Sugar pill
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.

Study groups in NCT03249558
Study group	Role	What they receive
Morphine, Duloxetine	Active comparator	Subjects will take a maximum dose of 60 mg/day of extended release morphine capsules and 60 mg of duloxetine capsules. Receives: Drug: Morphine; Drug: Duloxetine
Morphine, Placebo Duloxetine	Placebo comparator	Subjects will take a maximum dose of 60 mg/day of extended release morphine capsules and placebo duloxetine capsules. Receives: Drug: Morphine; Drug: Placebo
Placebo Morphine, Duloxetine	Placebo comparator	Subjects will take placebo morphine capsules and 60 mg of duloxetine capsules. Receives: Drug: Duloxetine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 20185 Apr 2022

First posted15 Aug 2017
Study start12 Mar 2018
Primary completion5 Apr 2022
Study completion5 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03249558
Sponsor's protocol ID: 2017P001589
Acronym: Duloxetine
Status last verified: Nov 2024
First submitted: 11 Aug 2017
Last updated: 14 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Combined Morphine and Duloxetine on Chronic Pain
ClinicalTrials.gov ID: NCT03249558
Acronym / sponsor ID: Duloxetine / 2017P001589
Conditions: Chronic Low Back Pain, Chronic Neck Pain
Keywords: Pain, Pain Management
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 12 Mar 2018 (actual)
Primary completion: 5 Apr 2022 (actual)
Study completion: 5 Apr 2022 (actual)
First posted: 15 Aug 2017 (actual)
Results: Posted 14 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Morphine, Duloxetine	Active comparator	Drug: Morphine, Drug: DuloxetineSubjects will take a maximum dose of 60 mg/day of extended release morphine capsules and 60 mg of duloxetine capsules.
Morphine, Placebo Duloxetine	Placebo comparator	Drug: Morphine, Drug: PlaceboSubjects will take a maximum dose of 60 mg/day of extended release morphine capsules and placebo duloxetine capsules.
Placebo Morphine, Duloxetine	Placebo comparator	Drug: Duloxetine, Drug: PlaceboSubjects will take placebo morphine capsules and 60 mg of duloxetine capsules.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subject is 18-70 years old.
Subject has chronic neck or back pain for at least 3 months.
Subject has a VAS ≥ 5.
Has not taken duloxetine in the last 3 months.
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.

Key exclusion criteria (11 listed)

Subject has major psychiatric disorders requiring recent hospitalization (within 3 months) such as major depression, bipolar disorder, schizophrenia, anxiety disorder, or psychotic disorder.
Subject is using illicit drugs detected by urine toxicology/drug screen.
Subject is pregnant or lactating/breast feeding.
Subject is allergic to morphine or duloxetine.
Subject is on an antidepressant including serotonin-norepinephrine reuptake inhibitors (SNRI), selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MorphineAlso: Morphine Sulfate Contin, Morphine Sulfate Instant ReleaseSubjects 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.	Drug	Morphine, Duloxetine, Morphine, Placebo Duloxetine
DuloxetineAlso: CymbaltaSubjects 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.	Drug	Morphine, Duloxetine, Placebo Morphine, Duloxetine
PlaceboAlso: Sugar pillSubjects 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.	Drug	Morphine, Placebo Duloxetine, Placebo Morphine, Duloxetine

Primary outcome

Overall Opioid Dose (Morphine-equivalent Dose in mg)
Time frame: 10 weeks
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.
Visual Analog Scale (VAS)
Time frame: 10 weeks
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.

Results and safety

Results posted to the registry on 14 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Morphine, Duloxetine	21	10
Morphine, Placebo Duloxetine	19	12
Placebo Morphine, Duloxetine	19	6

Primary outcome: Overall Opioid Dose (Morphine-equivalent Dose in mg)

Time frame: 10 weeks. Mean (Standard Deviation). Unit: mg

Measure	Morphine, Duloxetine n = 21	Morphine, Placebo Duloxetine n = 19	Placebo Morphine, Duloxetine n = 19
Value	19.6 (2.05)	19.6 (2.16)	19.6 (2.16)

Population analysed: The data collection was incomplete for the subjects who completed the study, therefore, the summary can not be provided. The total number of participants needed for analysis was not reached, and the results information provided are regarding the subjects who completed the study.

Primary outcome: Visual Analog Scale (VAS)

Time frame: 10 weeks. Mean (Standard Deviation). Unit: cm

Measure	Morphine, Duloxetine n = 10	Morphine, Placebo Duloxetine n = 12	Placebo Morphine, Duloxetine n = 6
Value	2.8 (3.05)	2.33 (3.05)	4.66 (3.05)

Population analysed: The data collection was incomplete for the subjects who completed the study, therefore, the summary and outcome can not be provided. The total number of participants needed for analysis was not reached, and the results information provided are regarding the subjects who completed the study. Due to the total number of participants needed for analysis not being met, the summary can not be provided.

Adverse events

Time frame: The adverse events were monitored and assessed through study completion, an average of 6 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Morphine, Duloxetine	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Morphine, Placebo Duloxetine	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Placebo Morphine, Duloxetine	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Limitations and caveats (from the sponsor): In this study we did not enroll enough participants to reach the number needed for our analysis to have power which is a limitation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Massachusetts General Hospital Center for Translational Pain ResearchLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Chronic Low Back Pain

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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Enrolling by invitation
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RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jianren Mao, MD, PhD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Morphine and Duloxetine in people with Chronic Low Back Pain and Chronic Neck Pain, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Opioid Dose (Morphine-equivalent Dose in mg) (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03249558.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.