Neuroimaging of Opioid Phase (OPAL) (OPAL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Opioid Use
• Intervention / Treatment: Other: Opioid Phase

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 Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy Westerhoff, BS; Phone Number: 919-684-3161; Email: chronicpainresearch@duke.edu
• Study Contact Backup: Name: Edna Evington, PhD; Phone Number: 919-684-2758; Email: edna.evington@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
      • Contact: Clinical Research Specialist; Phone Number: 919-684-2758; Email: ChronicPainResearch@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Study Population

Healthy volunteers and individuals with chronic pain (fibromyalgia). Opioid-taking patients will be recruited for comparison to non-opioid-taking patients.

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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")	Other: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During study visits up to 4 weeks apart

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Katherine T Martucci, PhD, Duke University

Publications and helpful links

Helpful Links

• Human Affect & Pain Laboratory (Duke Chronic Pain Lab)
• Please complete this survey as a first step to join the study.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: chronic pain; opioid; pain; functional MRI; fibromyalgia; brain; women; narcotic; opiate
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: Pro00110253; 1R01DA055850 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No