Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumati… (NCT06380985) | Clinical Trial Compass
WithdrawnNot Applicable
Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumatic Brain Injury
Stopped: PI resigned from his VA position
United States0Started 2024-06-24
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.