Opioid Approach Bias Modification

Chronic Pain Clinical Trial

— OABM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04436926
• Other study ID #: 19-29607
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: June 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Use

Intervention

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

Locations

Country	Name	City	State
United States	VA Medical Center San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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