Opioid Approach Bias Modification

Not Applicable

Completed

Interventions: Behavioral: sham training
Behavioral: opioid approach bias modification

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.

Recruitment & 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)

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in reaction time on an opioid approach-avoidance task across time, baseline to end of treatment, week 3	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

Name	Time	Method

Locations (1): VA Medical Center San Francisco
🇺🇸
San Francisco, California, United States

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