Opioid Approach Bias Modification

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Neural Basis of Approach Bias Modification in Opioid Users With Chronic Pain

Conditions
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Opioid Use, Chronic Pain

Intervention / Treatment
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* Behavioral: opioid approach bias modification
* Behavioral: sham training


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: opioid approach bias training<br>Immediately following screening, patients will be randomly assigned to receive 6 sessions of opioid approach bias modification taking place over two weeks. | Behavioral: opioid approach bias modification<br>* The investigators will use a training version of the Approach-Avoidance Task (AAT), in which patients are asked to respond to the format of presented pictures, irrespective of the pictures' content. Pushing a presented picture away will decrease picture size, whereas pulling a picture closer will increase size. There are 2 categories of pictures; 20 different opioid and 20 different non-medication alternative pain managing activities. Training effect is achieved by presenting opioid pictures in push format only and non-opioid pictures in pull format only. Two hundred training trials are presented per session.<br>|
| Sham Comparator: sham training<br>Immediately following screening, patients will be randomly assigned to receive 6 sessions of sham training taking place over two weeks. | Behavioral: sham training<br>* Sham training is identical to opioid approach bias training, except pictures are presented randomly in both formats.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in reaction time on an opioid approach-avoidance task across time, baseline to end of treatment, week 3 | millisecond reaction time of (opioid push - opioid pull) - (non-opioid push - opioid pull) on an opioid approach-avoidance task where participants are asked to respond to the format of presented pictures, irregardless of the content. There are two categories of pictures; 20 different opioid pictures and 20 different non-opioid pictures, with two-hundred trials. Millisecond reaction time will be measured at baseline, prior to each training session during the 2-week training period, and at week 3 post training assessment. Primary outcome is change in reaction time across time in active vs. sham condition. | baseline to end of treatment, week 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid, approach bias, chronic pain