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NCT Number: NCT05905419

Neuroimaging of Opioid Phase (OPAL)

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

HAPN Lab Manager

CONTACT

[email protected]

919-684-2758

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Healthy Controls:

  • 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

Inclusion criteria

for Individuals with Chronic Pain:

  • 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
  • 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):

  • 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

Treatment and study plan

Opioid Phase

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Angelina Xiong, BS

CONTACT

[email protected]

919-684-3136

HAPN Lab Manager

CONTACT

[email protected]

919-684-2758

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

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

Registry information

Official study title

Neurobiological Consequences of Long-Term Opioid Therapy in the Brain and Spinal Cord

Acronym: OPAL

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2023
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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