Status:
COMPLETED
Opioid Approach Bias Modification
Lead Sponsor:
University of California, San Francisco
Conditions:
Opioid Use
Chronic Pain
Eligibility:
All Genders
18-69 years
Phase:
NA
Brief Summary
To investigate the neurobiological mechanisms underlying opioid approach bias during a pilot RCT of opioid approach bias modification. The investigators are combining novel ultra-high field MRI techno...
Detailed Description
The proposed study is a pilot prospective, parallel groups, randomized, double blind, sham training-controlled, 6-session (over 2 weeks) clinical trial of opioid approach bias modification (OABM) in 2...
Eligibility Criteria
Inclusion
- Male and female veterans eligible for VA services
- Ages 18-69
- Chronic pain (current pain lasting ≥ 90 days)
- Prescribed chronic opioids (≥ 90 days in past year)
- High risk for opioid-related averse outcomes (≥ 20mg morphine equivalent daily dose).
Exclusion
- Psychotic, bipolar disorders or other psychiatric disorders judged to be unstable by the PI
- Current or past history of the following: intrinsic cerebral tumors, cerebrovascular accident/disease, brain aneurysm, arteriovenous malformations, surgical implantation of neurostimulators or cardiac pacemakers, demyelinating and neurodegenerative diseases, penetrating traumatic brain injury, and any other MRI contraindications.
- No female participant will be pregnant or actively attempting to conceive to prevent any unnecessary exposure to high magnetic fields or radio frequency energy to the unborn child.
- Concurrent participation in a treatment study
- Moderately Severe/Severe withdrawal from opioids based on a score of 25 or more on the Clinical Opiate Withdrawal Scale (COWS)
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04436926
Start Date
March 1 2021
End Date
November 30 2023
Last Update
June 14 2024
Active Locations (1)
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1
VA Medical Center San Francisco
San Francisco, California, United States, 94121