Clinical trial NCT04436926: Opioid Approach Bias Modification
Official title: The Neural Basis of Approach Bias Modification in Opioid Users With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Chronic Pain
Keywords: opioid
approach bias
chronic pain
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 technology with the promising treatment of modifying cognitive bias away from detrimental prescription drug use will generate novel neural data and potentially yield a new therapeutic tool to reduce problematic opioid use.

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 20 male and female veterans with chronic pain at high risk for opioid-related adverse events at the San Francisco Veterans Affairs Health Care System, between ages 18-69. The study consists of screening, 2-week cognitive training, Week-3 post-assessment. Assessment of the neurobiological mechanisms of opioid approach bias will be administered at baseline and Week-3.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Change in reaction time on an opioid approach-avoidance task across time, baseline to end of treatment, week 3
timeFrame: baseline to end of treatment, week 3
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: VA Medical Center San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Steven Batki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: David Pennington, PhD
role: PRINCIPAL_INVESTIGATOR
References: