[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heavy-alcoholic-consumption\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heavy-alcoholic-consumption":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100659729","self-administered-neurostimulation-intervention-for-firefighter-traumatic-stress-to-reduce-alcohol-use-pilot-study-100659729",false,"NCT07868055","Self-administered Neurostimulation Intervention for Firefighter Traumatic Stress to Reduce Alcohol Use: Pilot Study","Developing and Evaluating a Firefighter Self-administered Neurostimulation Intervention for Traumatic Stress to Reduce Alcohol Use","SANI-T","Inclusion Criteria:\n\n* Active-duty firefighter aged 18 to 64 years old.\n* Endorse at least one heavy drinking event within the past month based on sex-assigned-at-birth thresholds (males: 5+ standard drinks on a single day and\u002For 15+ over 7 days; females: 4+ standard drinks on a single day and\u002For 8+ over 7 days).\n* Meet DSM-5 criteria for mild, moderate, or severe alcohol use disorder. Report at least moderate posttraumatic stress (PTS) symptoms, defined as a PTSD Checklist for DSM-5 (PCL-5) score of 20 or greater.\n* Willing to attend research visits, complete EMA measurements, use the study device, and provide informed consent in English.\n\nExclusion Criteria:\n\n* Currently engaged in evidence-based PTSD psychotherapy or AUD-focused counseling at the time of randomization, or has experienced a past-month change in PTSD- or AUD-relevant medication.\n* High risk for moderate to severe alcohol withdrawal syndrome, indicated by a Prediction of Alcohol Withdrawal Severity Scale (PAWSS) score of 4 or greater.\n* Unmedicated psychotic disorder or unmedicated bipolar disorder with a manic episode in the past month.\n* History of epileptic seizures, neurological diseases, or traumatic brain injury with lasting effects.\n* Current evidence of an uncontrolled and\u002For clinically significant medical or psychiatric condition precluding device-related research participation.\n* Suicide attempt in the past month leading to hospital admission, or expressed suicidal ideation with intent and plan in the past month.\n* Presence of devices such as pacemakers, cochlear prostheses, or neurostimulators.\n* Current ear infection or abnormal ear anatomy that would prevent therapeutic earpiece contact to at least one ear.\n* Pregnant, lactating, or a person of childbearing potential not using adequate contraception.","ALL","18 Years","64 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to evaluate the feasibility, acceptability, and appropriateness of a transcutaneous auricular neurostimulation (tAN) protocol in firefighters who engage in heavy drinking, have at least a mild alcohol use disorder, and report above-average posttraumatic stress symptoms (PTS).\n\nThe main questions it aims to answer are:\n\n* How feasible do firefighter participants rate the study procedures on the Feasibility of Intervention Measure?\n* How do firefighter participants rate the acceptability of the study procedures (Acceptability of Intervention Measure) and the appropriateness of the tAN device (Intervention Appropriateness Measure)?\n\nResearchers will compare an active tAN condition (receiving therapeutic stimulation from the Sparrow device) to an active sham condition (receiving stimulation below a therapeutic level) to see if the intervention reduces PTS symptom severity and heavy drinking events, and to evaluate the clinical effects on insomnia, mental health symptoms, and quality of life.\n\nParticipants will:\n\n* Use the Sparrow device for at least 1 hour\u002Fday for 5 days\u002Fweek throughout a 4-week treatment phase.\n* Complete daily measures of traumatic event exposure, PTS symptom severity, alcohol use, and trauma-related drinking motivations.\n* Complete audio journals capturing their experience with symptoms and the device.\n* Wear sensors to record heart rate, heart rate variability, and sleep data throughout the intervention phase.\n\nComplete assessments immediately following treatment (Week 4) and one month later (Week 8).",[28,29,30],"Posttraumatic Stress Symptoms","Heavy Alcoholic Consumption","Alcohol Use Disorder (AUD)",[32,33,34,35,36,37],"posttraumatic stress symptoms","transcutaneous auricular neurostimulation","vagus nerve stimulation","trigeminal nerve stimulation","alcohol use disorder","firefighter","NOT_YET_RECRUITING","2026-10-06",{"date":41,"type":42},"2026-10-09","ACTUAL",{"date":44,"type":22},"2027-09-01",{"date":46,"type":22},"2028-06-30",{"name":48,"class":49},"University of Cincinnati","OTHER"]