Opioid Approach Bias Modification

NCT ID: NCT04436926

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-11-30

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.

Conditions

Opioid Use; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

opioid approach bias modification

Intervention Type: 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.

sham training

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

Group Type: SHAM_COMPARATOR

sham training

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

sham training

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Batki, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

David Pennington, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

VA Medical Center San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

19-29607

Identifier Type: -

Identifier Source: org_study_id