Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumatic Brain Injury
Withdrawn before enrolling · Not applicable · Has a placebo group
Conditions studied: Alcohol Use Disorder, Mild-Moderate Traumatic Brain Injury
In brief
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.
Key facts
- Study ID
- NCT06380985
- Run by
- VA Office of Research and Development
- People needed
- 0
- Starts
- 2024-06-24
- Expected to finish
- 2024-06-24
- Last updated by the study team
- 2024-06-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify 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:
- 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)
Where it is running
- San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States
Full record on ClinicalTrials.gov
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