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Opioid Approach Bias Modification (OABM)

Primary Purpose

Opioid Use, Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
opioid approach bias modification
sham training
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Opioid Use focused on measuring opioid, approach bias, chronic pain

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • VA Medical Center San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

opioid approach bias training

sham training

Arm Description

Immediately following screening, patients will be randomly assigned to receive 6 sessions of opioid approach bias modification taking place over two weeks.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2020
Last Updated
June 9, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04436926
Brief Title
Opioid Approach Bias Modification
Acronym
OABM
Official Title
The Neural Basis of Approach Bias Modification in Opioid Users With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Chronic Pain
Keywords
opioid, approach bias, chronic pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
opioid approach bias training
Arm Type
Experimental
Arm Description
Immediately following screening, patients will be randomly assigned to receive 6 sessions of opioid approach bias modification taking place over two weeks.
Arm Title
sham training
Arm Type
Sham Comparator
Arm Description
Immediately following screening, patients will be randomly assigned to receive 6 sessions of sham training taking place over two weeks.
Intervention Type
Behavioral
Intervention Name(s)
opioid approach bias modification
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
sham training
Intervention Description
Sham training is identical to opioid approach bias training, except pictures are presented randomly in both formats.
Primary Outcome Measure Information:
Title
Change in reaction time on an opioid approach-avoidance task across time, baseline to end of treatment, week 3
Description
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.
Time Frame
baseline to end of treatment, week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke L Lasher
Phone
415-221-4810
Ext
24495
Email
brooke.lasher@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Batki, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Pennington, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David L Pennington, PhD
Phone
415-221-4810
Ext
24504
Email
david.pennington2@va.gov
First Name & Middle Initial & Last Name & Degree
Brooke Lasher, BA
Phone
4152214810
Ext
24495
Email
brooke.lasher@va.gov
First Name & Middle Initial & Last Name & Degree
Steven L Batki, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Opioid Approach Bias Modification

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