Neuroimaging of Opioid Phase (OPAL)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	Female

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05905419
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Duke University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Katherine T Martucci, PhD
Principal Investigator Affiliation	Duke University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Pain, Opioid Use
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

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")

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

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Site Contact

Clinical Research Specialist

[email protected]

919-684-2758

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