Opioid Approach Bias Modification (OABM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Opioid Use
• Intervention / Treatment: Behavioral: opioid approach bias modification; Behavioral: sham training

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brooke L Lasher; Phone Number: 24495 415-221-4810; Email: brooke.lasher@va.gov

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121
      • Recruiting
      • VA Medical Center San Francisco
      • Contact: David L Pennington, PhD; Phone Number: 24504 415-221-4810; Email: david.pennington2@va.gov
      • Contact: Brooke Lasher, BA; Phone Number: 24495 4152214810; Email: brooke.lasher@va.gov
      • Principal Investigator: Steven L Batki, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Sham Comparator: sham training; Immediately following screening, patients will be randomly assigned to receive 6 sessions of sham training taking place over two weeks.	Behavioral: sham training; Sham training is identical to opioid approach bias training, except pictures are presented randomly in both formats.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Steven Batki, MD, University of California, San Francisco; Principal Investigator: David Pennington, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: chronic pain; opioid; approach bias
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 19-29607

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No