[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06771037":3,"trial-entities:NCT06771037":88,"trial-summary:NCT06771037":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":39,"secondary_outcomes":47,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":15,"eligibility_criteria":60,"std_ages":64,"locations":67,"central_contacts":77,"overall_officials":78,"references":82,"see_also_links":87},"NCT06771037","Caron001","Use of tAN® in Alcohol Withdrawal Management","The Use of Non-invasive Transcutaneous Auricular Neurostimulation (tAN®) in Alcohol Withdrawal Management","TERMINATED","2025-12-15","2026-08","2026-08-05","2025-04-21","Erin Takemoto","OTHER",false,"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.","This study will explore whether the use of a non-invasive Transcutaneous Auricular Neurostimulation (tAN®) device, Sparrow® Link, can be used to relieve symptoms of alcohol withdrawal symptoms and reduce the need for comfort medications during alcohol withdrawal management. This study will recruit 60 participants randomized to either active tAN® + Treatment as Usual (TAU) or sham tAN® + TAU, 30 participants in each arm. Data will be collected four times a day for 5 days, exploring ambient alcohol craving, mood, and sleep using Ecological Momentary Assessment (EMA; Wear-IT framework). Data for stress response, sleep and physical activity will also be collected using a fitness activity tracker (Garmin Vivosmart 4). In addition, the Clinical Institute Withdrawal Assessment, Revised (CIWA-AR) will be administered daily as well. Transcutaneous Auricular Neurostimulation has proven effective in reducing symptoms of opioid withdrawal and it is hypothesized that with the similar withdrawal symptom profile of alcohol withdrawal should prove effective in reducing symptoms of alcohol withdrawal as well.",[19],"Alcohol Withdrawal",[21,22,23],"Alcohol withdrawal","tAN","transcutaneous auricular neurostimulation","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},12,"ACTUAL",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"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.",[37,38],"Active Transcutaneous Auricular Neurostimulation (tAN)","Sham Transcutaneous Auricular Neurostimulation (tAN)",[40,44],{"measure":41,"description":42,"timeFrame":43},"Clinical Institute Withdrawal Assessment Scale, Revised (CIWA-Ar) score","Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in these primary outcomes between treatment and sham group. Mixed models take advantage of multiple measures from each individual, allowing for effects both between individuals and within each individual (e.g., across time). The CIWA-Ar is a 10-item scale measuring symptoms of alcohol withdrawal. The scores can range between 0-67. The total score is the sum of all scale items. Scores between 0-9 indicate absent to minimal withdrawal, Scores 10-19 indicate mild to moderate withdrawal and scores greater than 20 indicate severe withdrawal.","Baseline to end of study day 5",{"measure":45,"description":46,"timeFrame":43},"Amount of comfort medications utilized","Medications such as ibuprofen, Librium, lorazepam, promethazine, loperamide, and acetaminophen are often used to treat alcohol withdrawal. A t-test will be utilized to compare medication usage between active and sham group.",[48,51,54],{"measure":49,"description":50,"timeFrame":43},"Change in ambient alcohol craving","Change in ambient alcohol craving will be measured using a 0-100 Visual Analog Scale (VAS) delivered by smartphone using Ecological Momentary Assessment (EMA) delivered 4 times per day. EMA will be analyzed as a mixed model in the regression framework and will test effects of treatment status as between-group differences",{"measure":52,"description":53,"timeFrame":43},"Change in objective sleep","Objective sleep will be measured using wrist actigraphy. Analyses of actigraphy data will examine the effect of time (i.e., study day) to identify differences across condition in the amount of sleep (i.e. minutes).",{"measure":55,"description":56,"timeFrame":43},"Change in subjective sleep","Subjective sleep will be measured using EMA. Analyses of EMA data will examine the effect of time (i.e., study day) to identify differences across condition in the quality of sleep.","ALL","18 Years","65 Years",{"inclusion":61,"exclusion":62,"raw_text":63},[],[],"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.",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":69,"city":70,"state":71,"zip":72,"country":73,"geoPoint":74},"Caron Treatment Centers","Wernersville","Pennsylvania","19565","United States",{"lat":75,"lon":76},40.33009,-76.0805,[],[79],{"name":80,"affiliation":69,"role":81},"Erin Deneke, Ph.D.","PRINCIPAL_INVESTIGATOR",[83],{"pmid":84,"type":85,"citation":86},"35978394","BACKGROUND","Tirado CF, Washburn SN, Covalin A, Hedenberg C, Vanderpool H, Benner C, Powell DP, McWade MA, Khodaparast N. Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial. Bioelectron Med. 2022 Aug 18;8(1):12. doi: 10.1186\u002Fs42234-022-00095-x.",[],{"nct_id":4,"conditions":89,"biomarkers":90},[21],[],{"nct_id":4,"found":92,"summary":93,"prompt_version":103},true,{"design":94,"status":95,"heading":96,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This is an interventional study with 60 participants. You would be randomly assigned to either receive the tAN® device plus usual care, or usual care alone (sham group).","completed","Study of tAN® for Alcohol Withdrawal","This study is looking at whether a device called Transcutaneous Auricular Neurostimulation (tAN®) can help people manage alcohol withdrawal symptoms. tAN® works by sending small electrical signals to certain nerves. Researchers want to see if this device can reduce withdrawal symptoms and the need for comfort medications. You could be eligible if you are 18-65 years old, entering an inpatient program for alcohol withdrawal, and meet other specific criteria. The study will measure your withdrawal symptoms using a scale called CIWA-Ar and track how much comfort medication you use over five days. The study is currently unclear on its recruitment status and plans to enroll 60 participants.","The primary measurements for this study are taken from baseline to the end of study day 5.",107,"You would participate for five days, with data collected four times a day. This includes assessments of alcohol craving, mood, sleep, and physical activity, along with daily withdrawal symptom checks.","Not stated in the trial record.",[],"v2"]