Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by David L Pennington
Headshot of David L Pennington
David L Pennington

Description

Summary

The project will examine the neural associations of alcohol approach-bias and investigate the extent to which a neuroscience-based personalized cognitive training program will remediate alcohol approach-bias and improve recovery outcomes among heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild-moderate traumatic brain injury (mmTBI). Alcohol approach-bias modification (ApBM) is a cognitive training intervention designed to interrupt and modify automatic approach processes in response to alcohol cues. Modification of alcohol approach-bias and reductions in heavy alcohol use can be expected to reduce behaviors of self-harm and violence, increase adherence to medical care, reduce drinking-related medical costs, and promote healthier relationships. The long-term goal is to demonstrate the efficacy of ApBM to promote recovery from AUD in Veterans with chronic mmTBI. The investigators also aim to identify neural mechanisms associated with ApBM and other neurocognitive predictors of successful recovery. The evidence garnered from this study will be useful to inform the development of other behavioral and pharmacological treatments for Veterans with AUD with a history of mmTBI.

Official Title

Personalized Approach Bias Modification to Reduce Heavy Drinking and Improve Cognitive Control in Veterans With Mild to Moderate Traumatic Brain Injury

Details

This study is the first to test if Alcohol approach-bias modification (ApBM), delivered through virtual reality, as an add-on to outpatient treatment can reduce heavy alcohol use and improve neuro-cognitive outcomes among Veterans with mild to moderate traumatic brain injury (mmTBI) engaged in outpatient treatment for alcohol use disorder (AUD).

This will be a Phase II double-blind, randomized, sham-controlled clinical trial. Approximately 100 heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild to moderate traumatic brain injury (mmTBI) will be randomized into the study to complete a 3-week of either personalized ApBM or sham training (9 training sessions). Immediately following the 3-week training, a post-intervention Week-4 assessment will be administered. The participants will also be re-assessed again at Week 12 as the last study visit.

The aims of the study are as follows:

Aim 1: Establish the efficacy of a personalized alcohol ApBM to promote recovery from AUD among heavy drinking Veterans with a history of mmTBI.

Aim 2: Evaluate alcohol ApBM related change in fMRI cue-induced craving outcomes of treatment response within Default Mode Network.

Aim 3: Assess alcohol approach bias modification-related improvement in cognitive executive functioning domains that typically show deficit in heavy drinking Veterans with mmTBI and replicate preliminary associations between executive function domains and alcohol approach bias.

Keywords

Alcohol Use Disorder, Mild-Moderate Traumatic Brain Injury, Cognitive Bias Modification, Brain Injury, Traumatic, Alcohol-Related Disorders, Mental Disorders, Cognitive Training, Brain Injuries, Traumatic Brain Injuries, Alcoholism, Wounds and Injuries, Alcohol Drinking, Personalized VR Alcohol Approach Bias Modification (ApBM) Condition

Eligibility

You can join if…

Open to people ages 18-65

  • A history of mild-moderate TBI, as defined by American Congress of Rehabilitation Medicine (ACRM), in the chronic, stable phase of recovery (>6 months from injury)
  • Heavy drinking defined by NIH/NIAAA criteria (>7 drinks/week for women; >14 drinks/week for men) for at least one week in the last 90 days
  • Moderate to severe criteria for current alcohol use disorder (AUD) by DSM-5
  • Participants must also be engaged in VA outpatient AUD treatment and express a desire to reduce, stop, or maintain cessation of alcohol use

You CAN'T join if...

  • Unstable clinically significant psychiatric disorders or medical conditions that would create excessive risks, in the clinical judgment of the Principle Investigator
  • Current or history of the following:
  • Female participant who is pregnant or actively attempting to conceive (to prevent any unnecessary exposure to high magnetic fields or radiofrequency energy to the unborn child)
  • Concurrent participation in another clinical trial on AUD or TBI study
  • Requiring acute medical detoxification from alcohol, based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD)
  • Legal mandate to participate in an alcohol treatment program
  • Presence of severe TBI or penetrating head trauma
  • Starting use of AUD treatment medications (disulfiram, naltrexone, or acamprosate) within the past 4 weeks (must be on AUD treatment for longer than 4 weeks)

Location

  • San Francisco VA Medical Center, San Francisco, CA
    San Francisco California 94121-1563 United States

Lead Scientist at UCSF

  • David L Pennington
    Associate Professor, Psychiatry, School of Medicine. Authored (or co-authored) 39 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT06380985
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated