Opioid Approach Bias Modification

Overview

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.

Full Title of Study: “The Neural Basis of Approach Bias Modification in Opioid Users With Chronic Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 30, 2024

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.

Interventions

  • Behavioral: opioid approach bias modification
    • 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.
  • Behavioral: sham training
    • Sham training is identical to opioid approach bias training, except pictures are presented randomly in both formats.

Arms, Groups and Cohorts

  • Experimental: opioid approach bias training
    • Immediately following screening, patients will be randomly assigned to receive 6 sessions of opioid approach bias modification taking place over two weeks.
  • Sham Comparator: sham training
    • Immediately following screening, patients will be randomly assigned to receive 6 sessions of sham training taking place over two weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Change in reaction time on an opioid approach-avoidance task across time, baseline to end of treatment, week 3
    • Time Frame: 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 69 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, San Francisco
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Steven Batki, MD, Principal Investigator, University of California, San Francisco
    • David Pennington, PhD, Principal Investigator, University of California, San Francisco
  • Overall Contact(s)
    • Brooke L Lasher, 415-221-4810, brooke.lasher@va.gov

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