Neuroimaging of Opioid Phase (OPAL)

ConditionsChronic Pain Opioid Use

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorDuke University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

Opioid Phase
Other intervention
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

Treatment groups

140 Participants

are divided into 3 treatment groups

Group A: Female adults with chronic pain who take prescribed opioid medicationsExperimental treatment 1 intervention

Group B: Female adults with chronic pain who do not take opioid medicationsNo intervention 0 interventions

Group C: Healthy controlsNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

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.

Time frame

During study visits up to 4 weeks apart

Secondary outcomes

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

Compare spinal cord fMRI-based response and resting-state functional connectivity.

Time frame

During study visits up to 4 weeks apart

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute on Drug Abuse (NIDA)