[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575342":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":55,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Caron Treatment Centers","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Transcutaneous Auricular Neurostimulation (tAN)","EXPERIMENTAL","Transcutaneous auricular stimulation will be delivered using the Sparrow® Link in addition to treatment as usual (TAU). The Sparrow® Link will be set to the following outputs (range 0 mA - 5.0 mA, pulse width 250 µs, frequency 15 Hz at Region 1 (Vagus) and 100 Hz at Region 2 (Trigeminal). Device will be worn for 5 days.",[13],"Device: Transcutaneous Auricular Neurostimulation (tAN)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Transcutaneous Auricular Neurostimulation (tAN)","SHAM_COMPARATOR","The Sparrow® Link will be set to the sham condition for participants in the sham group and no current will be delivered to either the inner or outer ear, but the screen will appear identical to the active group. Sham group will receive treatment as usual. Sham device will be worn for 5 days.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Transcutaneous Auricular Neurostimulation (tAN)","Transcutaneous Auricular stimulation will be delivered using the Spark Biomedical Sparrow Link pulse generator with Sparrow Ascent earpieces. The Sparrow Link generator is based on FDA-cleared predicate Sparrow Ascent.",[9,15],null,[27],{"name":28,"affiliation":5,"role":29},"Erin Deneke, Ph.D.","PRINCIPAL_INVESTIGATOR",[31,35],{"name":28,"role":32,"phone":33,"phoneExt":25,"email":34},"CONTACT","610-743-6242","edeneke@caron.org",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Dean Stankoski, M.S.","610-743-6224","dstankoski@caron.org",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Wernersville","Pennsylvania","19565","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-76.0805,40.33009,{"lat":51,"lon":50},[54],{"name":28,"role":32,"phone":33,"phoneExt":25,"email":34},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Erin Deneke","Senior Director of Research","100575342","use-of-tan-in-alcohol-withdrawal-management-100575342",false,"NCT06771037","Use of tAN® in Alcohol Withdrawal Management","The Use of Non-invasive Transcutaneous Auricular Neurostimulation (tAN®) in Alcohol Withdrawal Management","Inclusion Criteria:\n\n1. Ages 18 years old to 65 years old\n2. Entering an inpatient substance use treatment program for alcohol withdrawal management.\n3. Score a 27 or higher on the WHO-ASSIST V3.0\n4. Is proficient in English\n5. Score of a 4 or higher on the Prediction of Alcohol Withdrawal Severity Scale (PAWSS)\n6. Able to provide written informed consent.\n7. Stated willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 or \\> 65\n2. Requires medical tapering from benzodiazepines or opioids.\n3. Has a history of epileptic seizures or seizures due to alcohol withdrawal.\n4. Has a cardiac pacemaker, cochlear prosthesis, neurostimulator or other device for which tAN® would be contraindicated.\n5. Has abnormal ear anatomy or an ear infection is present.\n6. Is pregnant.\n7. Has any serious medical disease or condition which, in the judgment of the Principal Investigator or his\u002Fher designee, would make study participation unsafe, or would make intervention compliance difficult.","ALL","18 Years","65 Years",{"count":70,"type":71},60,"ESTIMATED","INTERVENTIONAL",[74],"NA","This research study is being conducted to learn if Transcutaneous Auricular Neurostimulation (tAN®) may be effective in treating alcohol withdrawal syndrome. Transcutaneous Auricular Neurostimulation (tAN®) works by delivering small electrical stimulations to the Vagus and Trigeminal nerves. This study will be conducted over the course of five days. Participants will be enrolled within 24 hours of entering treatment for alcohol withdrawal management. A total of 60 individuals will be enrolled and randomly assigned to either active (treatment with the device + treatment as usual) or sham (treatment as usual) group. Data will be collected on alcohol craving, use of comfort medications, sleep, and mood.",[77],"Alcohol Withdrawal",[79,80,81],"Alcohol withdrawal","tAN","transcutaneous auricular neurostimulation","2025-04-16",{"date":84,"type":85},"2025-04-20","ACTUAL",{"date":87,"type":71},"2025-04-21",{"date":89,"type":71},"2027-07-01",{"name":57,"class":6},1]