Opioid Approach Bias Modification (OABM)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Chronic Pain; Opioid Use

Treatments: Behavioral: sham training; Behavioral: opioid approach bias modification

Study type: Interventional

Funder types: Other

Identifiers

NCT04436926

19-29607

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

opioid approach bias training

Experimental group

Description:

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

Treatment:

Behavioral: opioid approach bias modification

sham training

Sham Comparator group

Description:

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

Treatment:

Behavioral: sham training