Neuroimaging of Opioid Phase (OPAL) (OPAL)

June 1, 2026 updated by: Duke University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Study Population

Healthy volunteers and individuals with chronic pain (fibromyalgia). Opioid-taking patients will be recruited for comparison to non-opioid-taking patients.

Description

Inclusion Criteria for Healthy Controls:

  1. female and ages 18+
  2. ability to read/understand English and give consent to participate
  3. no current or history of chronic pain
  4. not regularly taking any pain-relieving or mood-altering medications (per PI discretion)
  5. absence of use of opioid medications

Inclusion Criteria for Individuals with Chronic Pain:

  1. female and ages 18 +
  2. ability to read/understand English and give consent to participate
  3. self-reported or physician diagnosis of fibromyalgia and/or chronic pain
  4. 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

Exclusion Criteria (for both groups):

  1. limited ability to participate fully in behavioral tasks, longitudinal follow-up
  2. MRI contraindication
  3. any factors that at the discretion of the investigators would adversely affect the participant or the integrity of the study
  4. male

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Female adults with chronic pain who take prescribed opioid medications
Opioid taking participants will undergo two study visits, one for each opioid phase ("peak" or "trough")
Other: Opioid Phase
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
No Intervention: Female adults with chronic pain who do not take opioid medications
Participants with chronic pain who are not taking opioids will undergo one study visit
No Intervention: Healthy controls
Healthy female participants who are not taking opioids will undergo one study visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During study visits up to 4 weeks apart

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterize spinal cord fMRI-based activity related to neurobiological consequences of opioid therapy
Time Frame: During study visits up to 4 weeks apart
Compare spinal cord fMRI-based response and resting-state functional connectivity.
During study visits up to 4 weeks apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Katherine T Martucci, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00110253
  • 1R01DA055850 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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