Recruiting

Opioid Phase

Sponsor:

Duke University

Code:

NCT05905419

Conditions

Chronic Pain

Opioid Use

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Opioid Phase

Study Details

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.

Conditions

Chronic Pain

Opioid Use

Study ID

NCT05905419

Start date

Jun 1, 2023

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

140 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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

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

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 ]

Central Contacts and Locations

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

More Information

Sponsor

Duke University

Last update posted

Jun 3, 2026

Last verified

Apr, 2026

Keywords

  • fibromyalgia
  • women
  • brain
  • functional MRI
  • opioid
  • opiate
  • narcotic
  • chronic pain
  • pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Duke University on 2026-06-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.