Summary

Eligibility
for people ages 18-69 (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
Steven Batki, MD
Photo of Steven Batki
Steven Batki

Description

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.

Official Title

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

Details

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.

Keywords

Opioid Use Chronic Pain opioid approach bias Analgesics, Opioid opioid approach bias modification opioid approach bias training

Eligibility

You can join if…

Open to people ages 18-69

  • 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).

You CAN'T join if...

  • 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)

Location

  • VA Medical Center San Francisco
    San Francisco California 94121 United States

Lead Scientist at UCSF

  • Steven Batki, MD
    Steven L. Batki, M.D. is Professor of Psychiatry, in Residence, at the University of California, San Francisco (UCSF) School of Medicine and Chief of the Substance Abuse Programs and Director of the Addiction Psychiatry Research Program at the San Francisco VA Medical Center (SFVAMC), where he also directs the UCSF Addiction Psychiatry Fellowship Program.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04436926
Study Type
Interventional
Last Updated