RecruitingNot Applicable

Neuroimaging of Opioid Phase (OPAL)

United States140 participantsStarted 2023-06-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Characterize brain fMRI-based activity related to neurobiological consequences of opioid therapy

Timeframe: During study visits up to 4 weeks apart

Trial details

NCT IDNCT05905419

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

HAPN Lab Manager

919-684-2758 chronicpainresearch@duke.edu

View on ClinicalTrials.gov More Chronic Pain trials