Neuroimaging of Opioid Phase (OPAL)

Duke University

Status: Enrolling

Conditions: Chronic Pain; Opioid Use

Treatments: Other: Opioid Phase

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05905419

1R01DA055850 (U.S. NIH Grant/Contract)

Pro00110253

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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 design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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140 participants in 3 patient groups

Female adults with chronic pain who take prescribed opioid medications

Experimental group

Description:

Opioid taking participants will undergo two study visits, one for each opioid phase ("peak" or "trough")

Treatment:

Other: Opioid Phase

Female adults with chronic pain who do not take opioid medications

No Intervention group

Description:

Participants with chronic pain who are not taking opioids will undergo one study visit

Healthy controls

No Intervention group

Description:

Healthy female participants who are not taking opioids will undergo one study visit