nctId: NCT06380985 id: NURA-009-23F 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 overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-06-30 date: 2027-12-31 date: 2024-04-24 date: 2024-04-26 name: VA Office of Research and Development class: FED 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. conditions: Alcohol Use Disorder conditions: Mild-Moderate Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This will be a Phase II double-blind, randomized, sham-controlled clinical trial. primaryPurpose: TREATMENT 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 count: 100 type: ESTIMATED name: Personalized VR Alcohol Approach Bias Modification (ApBM) Condition name: Sham Condition measure: Percent of Heavy Drinking Days measure: Cue-induced fMRI BOLD-signal craving activation contrasts measure: Cognitive flexibility sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Francisco VA Medical Center, San Francisco, CA city: San Francisco state: California zip: 94121-1563 country: United States name: David L Pennington role: CONTACT phone: 415-221-4810 phoneExt: 24504 email: david.pennington2@va.gov name: Yim Fan Wong, BS role: CONTACT phone: (415) 221-4810 phoneExt: 22329 email: yimfan.wong@va.gov name: David L Pennington role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 hasResults: False