Neuroimaging of Opioid Phase (OPAL)

Chronic Pain Clinical Trial

— OPAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05905419
• Other study ID #: Pro00110253
• Secondary ID: 1R01DA055850
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: April 2024
• Source: Duke University
• Contact: Amy Westerhoff, BS
• Phone: 919-684-3161
• Email: chronicpainresearch[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Use

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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