Clinical trial NCT06380985: Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumatic Brain Injury
Official title: Personalized Approach Bias Modification to Reduce Heavy Drinking and Improve Cognitive Control in Veterans With Mild to Moderate Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alcohol Use Disorder
Mild-Moderate Traumatic Brain Injury
Keywords: Cognitive Bias Modification
Alcohol Use Disorder
Brain Injury, Traumatic
Alcohol-Related Disorders
Mental Disorders
Cognitive Training
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a Phase II double-blind, randomized, sham-controlled clinical trial.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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:

  * intrinsic cerebral tumors
  * demyelinating and neurodegenerative diseases
  * aneurysm
  * arteriovenous malformations
  * cerebrovascular or peripheral vascular disease
  * severe or penetrating traumatic brain injury
  * documented learning disabilities
  * surgical implantation of neurostimulators or cardiac pacemakers and any other MRI contraindications

    * These conditions/diseases are known to influence the neurocognitive and MR-derived neurobiological measures proposed in this application
* 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)

Primary outcomes:
measure: Percent of Heavy Drinking Days
timeFrame: 90 days post-randomization
Secondary outcomes:
measure: Cue-induced fMRI BOLD-signal craving activation contrasts
timeFrame: Week 4 - The week following completion of cognitive training.
Other outcomes:
measure: Cognitive flexibility
timeFrame: Week 4 - The week following completion of cognitive training.
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: David L Pennington
role: PRINCIPAL_INVESTIGATOR
References: