Chronic PainOPALNCT05905419
Neuroimaging of Opioid Phase (OPAL)
A study testing Opioid Phase in people with Chronic Pain and Opioid Use, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to compare activity in the brains of female adults with chronic pain and/or opioid use, and healthy female adults that may help to develop new and targeted treatments for adults with chronic pain and alternatives to opioid therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Opioid Use
- What is being tested?
- Opioid Phase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female and ages 18+
- ability to read/understand English and give consent to participate
- no current or history of chronic pain
- not regularly taking any pain-relieving or mood-altering medications (per PI discretion)
- absence of use of opioid medications
- female and ages 18 +
Show all 9Show fewer
- ability to read/understand English and give consent to participate
- self-reported or physician diagnosis of fibromyalgia and/or chronic pain
- current use of opioid medication(s) for inclusion in the opioid patient group -OR- absence of use of opioid medications for inclusion in the non-opioid patient group
Who cannot join
- limited ability to participate fully in behavioral tasks, longitudinal follow-up
- MRI contraindication
- any factors that at the discretion of the investigators would adversely affect the participant or the integrity of the study
- male
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
HAPN Lab Manager, 919-684-2758, ChronicPainResearch@duke.edu
About this study
Official title: Neurobiological Consequences of Long-Term Opioid Therapy in the Brain and Spinal Cord
The purpose of this study is to compare activity in the brains of female adults with chronic pain and/or opioid use, and healthy female adults that may help to develop new and targeted treatments for adults with chronic pain and alternatives to opioid therapy.
Read the detailed description
The objective of the study is to determine differences in neurophysiology and behavior during different phases of opioid use in patients. Study activities will include neuroimaging (MRI and fMRI), behavioral tasks, sensory testing, blood draws, and questionnaires. The neuroimaging data will be analyzed using specialized software; data from questionnaires, sensory testing, and behavioral task performance will be analyzed using standard statistical software. Risks and safety concerns include standard, minimal risks associated with MRI scans, sensory testing, blood draws, and confidentiality.
- Conditions
- Chronic Pain, Opioid Use
- Being tested
- Opioid Phase
- Keywords
- fibromyalgia, women, brain, functional MRI, opioid, opiate, narcotic, chronic pain, pain
- Medical subject headings
- Chronic Pain, Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid PhaseOther
Opioid-taking patients are assigned to take their prescribed opioid medication before ("peak" opioid phase) during 1 scan and after ("trough" opioid phase) during the other MRI scan
| Study group | Role | What they receive |
|---|---|---|
| Female adults with chronic pain who take prescribed opioid medications | Experimental | Opioid taking participants will undergo two study visits, one for each opioid phase ("peak" or "trough") Receives: Other: Opioid Phase |
| Female adults with chronic pain who do not take opioid medications | No intervention | Participants with chronic pain who are not taking opioids will undergo one study visit |
| Healthy controls | No intervention | Healthy female participants who are not taking opioids will undergo one study visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize brain fMRI-based activity related to neurobiological consequences of opioid therapy
Compare brain fMRI-based response to reward stimuli during a monetary incentive delay (MID) task and functional connectivity of brain reward circuitry during resting state.
Measured: During study visits up to 4 weeks apart
Secondary outcomes (1)
Characterize spinal cord fMRI-based activity related to neurobiological consequences of opioid therapy
Compare spinal cord fMRI-based response and resting-state functional connectivity.
Measured: During study visits up to 4 weeks apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jun 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Katherine T Martucci, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905419
- Sponsor's protocol ID
- Pro00110253
- Other IDs
- 1R01DA055850
- Acronym
- OPAL
- Status last verified
- Apr 2026
- First submitted
- 7 Jun 2023
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Consequences of Long-Term Opioid Therapy in the Brain and Spinal Cord
- ClinicalTrials.gov ID
- NCT05905419
- Acronym / sponsor ID
- OPAL / Pro00110253
- Conditions
- Chronic Pain, Opioid Use
- Keywords
- fibromyalgia, women, brain, functional MRI, opioid, opiate, narcotic, chronic pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Jun 2023 (actual)
- 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.
The purpose of this study is to compare activity in the brains of female adults with chronic pain and/or opioid use, and healthy female adults that may help to develop new and targeted treatments for adults with chronic pain and alternatives to opioid therapy.
Detailed description
The objective of the study is to determine differences in neurophysiology and behavior during different phases of opioid use in patients. Study activities will include neuroimaging (MRI and fMRI), behavioral tasks, sensory testing, blood draws, and questionnaires. The neuroimaging data will be analyzed using specialized software; data from questionnaires, sensory testing, and behavioral task performance will be analyzed using standard statistical software. Risks and safety concerns include standard, minimal risks associated with MRI scans, sensory testing, blood draws, and confidentiality.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Female adults with chronic pain who take prescribed opioid medications | Experimental | Other: Opioid PhaseOpioid taking participants will undergo two study visits, one for each opioid phase ("peak" or "trough") |
| Female adults with chronic pain who do not take opioid medications | No intervention | –Participants with chronic pain who are not taking opioids will undergo one study visit |
| Healthy controls | No intervention | –Healthy female participants who are not taking opioids will undergo one study visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- female and ages 18+
- ability to read/understand English and give consent to participate
- no current or history of chronic pain
- not regularly taking any pain-relieving or mood-altering medications (per PI discretion)
- absence of use of opioid medications
Key exclusion criteria (4 listed)
- limited ability to participate fully in behavioral tasks, longitudinal follow-up
- MRI contraindication
- any factors that at the discretion of the investigators would adversely affect the participant or the integrity of the study
- male
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 |
|---|---|---|
| Opioid PhaseOpioid-taking patients are assigned to take their prescribed opioid medication before ("peak" opioid phase) during 1 scan and after ("trough" opioid phase) during the other MRI scan | Other | Female adults with chronic pain who take prescribed opioid medications |
Primary outcome
Characterize brain fMRI-based activity related to neurobiological consequences of opioid therapy
Time frame: During study visits up to 4 weeks apart
Compare brain fMRI-based response to reward stimuli during a monetary incentive delay (MID) task and functional connectivity of brain reward circuitry during resting state.
1 secondary outcome
Characterize spinal cord fMRI-based activity related to neurobiological consequences of opioid therapy
Time frame: During study visits up to 4 weeks apart
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Human Affect \& Pain Laboratory (Duke Chronic Pain Lab)Link provided by the sponsor.
- Please complete this survey as a first step to join the study.Link provided by the sponsor.
- 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.
Katherine T Martucci, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Phase in people with Chronic Pain and Opioid Use, run by Duke University 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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HAPN Lab Manager (919-684-2758, chronicpainresearch@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize brain fMRI-based activity related to neurobiological consequences of opioid therapy (time frame: During study visits up to 4 weeks apart). 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 3 Jun 2026.