Neuroimaging of Opioid Phase (OPAL)
OPAL
Neurobiological Consequences of Long-Term Opioid Therapy in the Brain and Spinal Cord
2 other identifiers
interventional
140
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Jun 2023
Longer than P75 for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
June 7, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
June 3, 2026
April 1, 2026
4.1 years
June 7, 2023
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
During study visits up to 4 weeks apart
Secondary Outcomes (1)
Characterize spinal cord fMRI-based activity related to neurobiological consequences of opioid therapy
During study visits up to 4 weeks apart
Study Arms (3)
Female adults with chronic pain who take prescribed opioid medications
EXPERIMENTALOpioid 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 INTERVENTIONParticipants with chronic pain who are not taking opioids will undergo one study visit
Healthy controls
NO INTERVENTIONHealthy female participants who are not taking opioids will undergo one study visit
Interventions
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
Eligibility Criteria
You may qualify if:
- 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 +
- ability to read/understand English and give consent to participate
- self-reported or physician diagnosis of fibromyalgia and/or chronic pain
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Institutes of Health (NIH)collaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine T Martucci, PhD
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2023
First Posted
June 15, 2023
Study Start
June 1, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
June 3, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share