Low Back PainPhase 1NCT02824276
Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain
A Phase 1 study testing Oxycodone or morphine sulfate immediate release (MSIR) in people with Low Back Pain, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Chronic low back pain (CLBP) afflicts up to 50 million U.S. adults and is a primary cause of disability and reduced quality of life. The prescription of opioids for chronic low back pain (CLBP) has increased substantially within the past decade in the U.S. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Oxycodone or morphine sulfate immediate release (MSIR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2017to 1 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 25-65
- CLBP lasting for more than 6 months as the primary complaint
- typical pain ratings ≥ 4/10 on a visual analogue scale
- candidate for oral opioid therapy as assessed at the BWH Pain Management Center
- able to speak and understand English.
Who cannot join
- evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures
- current (i.e., active) substance use disorder (SUD)
- past history of persistent opioid use (i.e., opioid use for more than 6 months) given that this could affect the biological systems of interest in the present study
- history of myocardial infarction or other serious cardiovascular condition
- current peripheral neuropathy
- current pregnancy, or intention to become pregnant during the study
- current intrathecal pump.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02467
About this study
Chronic low back pain (CLBP) afflicts up to 50 million U.S. adults and is a primary cause of disability and reduced quality of life. The prescription of opioids for chronic low back pain (CLBP) has increased substantially within the past decade in the U.S. As noted by the CDC in their recent Guideline (released in March 2016): "Opioids are commonly prescribed for pain. An estimated 20% of patients presenting to physician offices with noncancer pain symptoms or pain-related diagnoses (including acute and chronic pain) receive an opioid prescription. Interestingly, patients scoring very high on measures of psychological distress tend to be systematically excluded from RCTs, even though this subgroup of patients is highly prevalent within the chronic pain population.
This study will provide key information on individual differences in the outcomes of opioid treatment, and its findings should facilitate more effective tailoring of analgesic regimens to individual patient characteristic.
Read the detailed description
Changes in pain sensitivity will be examined (i.e., OIH) among subgroups of CLBP patients prescribed oral opioid therapy.
Investigators will conduct a moderate-term, double-blind, randomized controlled trial, and use quantitative sensory testing (QST) to evaluate whether changes in pain sensitivity and pain modulation occur as a result of long-term opioid use. Investigators hypothesize that increases in pain sensitivity (i.e., OIH) and maladaptive changes in endogenous pain modulation (i.e., enhanced temporal summation of pain) will occur as a result of long-term opioid use, but that these changes will be observed predominantly among patients with high levels of negative affect and pain-related catastrophizing.
- Conditions
- Low Back Pain
- Being tested
- Oxycodone or morphine sulfate immediate release (MSIR), Placebo Treatment
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone or morphine sulfate immediate release (MSIR)Drug
Also called Oral Opioid Medication
Oxycodone or morphine sulfate immediate release (MSIR)
Placebo TreatmentDrug
Lactose (Appearance and Weight-matched placebo capsules)
| Study group | Role | What they receive |
|---|---|---|
| Oral Opioid Medication | Experimental | The primary study medication will be oxycodone, with morphine sulfate immediate release (MSIR) as a backup in case of side effects Receives: Drug: Oxycodone or morphine sulfate immediate release (MSIR) |
| Placebo Treatment | Placebo comparator | Placebo medications will be encapsulated in an opaque blinding capsule to ensure adequate blinding of study medications Receives: Drug: Placebo Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain Sensitivity (Quantitative Sensory Testing)
Pain Sensitivity will be assessed by Quantitative Sensory testing
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start6 Jan 2017
- Primary completion30 Dec 2022
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Robert Edwards, Brigham and Women's Hospital
- Investigators
- Robert Edwards, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824276
- Sponsor's protocol ID
- 2016P000725
- Status last verified
- May 2023
- First submitted
- 28 Jun 2016
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02824276
- Acronym / sponsor ID
- 2016P000725
- Conditions
- Low Back Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic low back pain (CLBP) afflicts up to 50 million U.S. adults and is a primary cause of disability and reduced quality of life. The prescription of opioids for chronic low back pain (CLBP) has increased substantially within the past decade in the U.S. As noted by the CDC in their recent Guideline (released in March 2016): "Opioids are commonly prescribed for pain. An estimated 20% of patients presenting to physician offices with noncancer pain symptoms or pain-related diagnoses (including acute and chronic pain) receive an opioid prescription. Interestingly, patients scoring very high on measures of psychological distress tend to be systematically excluded from RCTs, even though this subgroup of patients is highly prevalent within the chronic pain population.
This study will provide key information on individual differences in the outcomes of opioid treatment, and its findings should facilitate more effective tailoring of analgesic regimens to individual patient characteristic.
Detailed description
Changes in pain sensitivity will be examined (i.e., OIH) among subgroups of CLBP patients prescribed oral opioid therapy.
Investigators will conduct a moderate-term, double-blind, randomized controlled trial, and use quantitative sensory testing (QST) to evaluate whether changes in pain sensitivity and pain modulation occur as a result of long-term opioid use. Investigators hypothesize that increases in pain sensitivity (i.e., OIH) and maladaptive changes in endogenous pain modulation (i.e., enhanced temporal summation of pain) will occur as a result of long-term opioid use, but that these changes will be observed predominantly among patients with high levels of negative affect and pain-related catastrophizing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Opioid Medication | Experimental | Drug: Oxycodone or morphine sulfate immediate release (MSIR)The primary study medication will be oxycodone, with morphine sulfate immediate release (MSIR) as a backup in case of side effects |
| Placebo Treatment | Placebo comparator | Drug: Placebo TreatmentPlacebo medications will be encapsulated in an opaque blinding capsule to ensure adequate blinding of study medications |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 25-65
- CLBP lasting for more than 6 months as the primary complaint
- typical pain ratings ≥ 4/10 on a visual analogue scale
- candidate for oral opioid therapy as assessed at the BWH Pain Management Center
- able to speak and understand English.
Key exclusion criteria (7 listed)
- evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures
- current (i.e., active) substance use disorder (SUD)
- past history of persistent opioid use (i.e., opioid use for more than 6 months) given that this could affect the biological systems of interest in the present study
- history of myocardial infarction or other serious cardiovascular condition
- current peripheral neuropathy
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 |
|---|---|---|
| Oxycodone or morphine sulfate immediate release (MSIR)Also: Oral Opioid MedicationOxycodone or morphine sulfate immediate release (MSIR) | Drug | Oral Opioid Medication |
| Placebo TreatmentLactose (Appearance and Weight-matched placebo capsules) | Drug | Placebo Treatment |
Primary outcome
Changes in Pain Sensitivity (Quantitative Sensory Testing)
Time frame: 6 months
Pain Sensitivity will be assessed by Quantitative Sensory testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Robert Edwards, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxycodone or morphine sulfate immediate release (MSIR) in people with Low Back Pain, run by Brigham and Women's 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 7 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 4 Feb 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Pain Sensitivity (Quantitative Sensory Testing) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2026.