OPAL: Neuroimaging of Opioid Phase

Sponsor

Duke University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05905419

Collaborator

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

140

Enrollment

Location

48.5

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain Opioid Use	Other: 2 Study Visits with MRI Scanning Other: 1 Study Visit with MRI Scanning Drug: Opioid Randomization

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

140 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Neuroimaging of Opioid Phase

Anticipated Study Start Date :

Jun 15, 2023

Anticipated Primary Completion Date :

Jun 30, 2026

Anticipated Study Completion Date :

Jun 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
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")	Other: 2 Study Visits with MRI Scanning Participant undergoes MRI scanning, blood draw(s), urine sample(s) Drug: Opioid Randomization Participant is randomized to take their prescribed opioid medication before ("peak" opioid phase) or after ("trough" opioid phase) the MRI scan
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	Other: 1 Study Visit with MRI Scanning Participant undergoes MRI scanning, blood draw, urine sample
Healthy controls Healthy female participants who are not taking opioids will undergo one study visit	Other: 1 Study Visit with MRI Scanning Participant undergoes MRI scanning, blood draw, urine sample

Arm

Intervention/Treatment

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")

Other: 2 Study Visits with MRI Scanning

Participant undergoes MRI scanning, blood draw(s), urine sample(s)

Drug: Opioid Randomization

Participant is randomized to take their prescribed opioid medication before ("peak" opioid phase) or after ("trough" opioid phase) the MRI scan

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

Other: 1 Study Visit with MRI Scanning

Participant undergoes MRI scanning, blood draw, urine sample

Healthy controls

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

Other: 1 Study Visit with MRI Scanning

Participant undergoes MRI scanning, blood draw, urine sample

Outcome Measures

Primary Outcome Measures

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

Characterize spinal cord fMRI-based activity related to neurobiological consequences of opioid therapy [During study visits up to 4 weeks apart]
Compare spinal cord fMRI-based response and resting-state functional connectivity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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