Opioid Approach Bias Modification

NCT04436926 | Completed

• 1 other identifier: 19-29607
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Chronic Pain

Keywords

opioid; approach bias; chronic pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

opioid approach bias training

EXPERIMENTAL

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

sham training

SHAM COMPARATOR

Immediately following screening, patients will be randomly assigned to receive 6 sessions of sham training taking place over two weeks.

Behavioral: sham training

Interventions

opioid approach bias modification BEHAVIORAL

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.

opioid approach bias training

sham training BEHAVIORAL

Sham training is identical to opioid approach bias training, except pictures are presented randomly in both formats.

sham training

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

VA Medical Center San Francisco

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven Batki, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• David Pennington, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: March 1, 2021
• Primary Completion: October 30, 2023
• Study Completion: November 30, 2023
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)