protocolSection identificationModule nctId: NCT06380985, orgStudyIdInfo id: NURA-009-23F, secondaryIdInfos id: 1I01CX002715-01A1, type: OTHER_GRANT, domain: Clinical Science Research & Development, briefTitle: Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumatic Brain Injury, acronym: TABM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: VA Office of Research and Development, class: FED, descriptionModule briefSummary: 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., conditionsModule conditions: Alcohol Use Disorder, conditions: Mild-Moderate Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This will be a Phase II double-blind, randomized, sham-controlled clinical trial., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The identity of ApBM and Sham will not be known to investigators or patients. To maintain the blind, the participant and the research coordinator (naïve to ApBM) administering the participant's training will be blind to whether "1" or "2" is ApBM or Sham. The research coordinator will receive the patient assignment from statistical software at time of randomization. The key that determines assignment of ApBM or Sham to condition "1" or "2" will be known by an addiction research program affiliate PI otherwise uninvolved in the current study. They will document this key in a locked electronic file. The study blind will be broken on completion of the study and after the study database has been locked., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Personalized VR Alcohol Approach Bias Modification (ApBM) Condition, interventions name: Sham Condition, outcomesModule primaryOutcomes measure: Percent of Heavy Drinking Days, secondaryOutcomes measure: Cue-induced fMRI BOLD-signal craving activation contrasts, otherOutcomes measure: Cognitive flexibility, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: San Francisco VA Medical Center, San Francisco, CA, city: San Francisco, state: California, zip: 94121-1563, country: United States, contacts name: David L Pennington, role: CONTACT, phone: 415-221-4810, phoneExt: 24504, email: david.pennington2@va.gov, contacts name: Yim Fan Wong, BS, role: CONTACT, phone: (415) 221-4810, phoneExt: 22329, email: yimfan.wong@va.gov, contacts name: David L Pennington, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False