Clinical Trials Logo

Clinical Trial Summary

Adolescent nonsuicidal self-injury (NSSI) and alcohol misuse, alone and especially in combination, portend significant functional impairment in adulthood (e.g., relationship dysfunction, depression, suicidality). Although psychosocial interventions for NSSI and substance use are effective for some, they are also expensive and require highly trained clinicians. Treatment is therefore often unavailable to disadvantaged adolescents and those who live rurally. Thus, lower-cost alternative treatments are needed. We will evaluate the efficacy of noninvasive transcutaneous vagus nerve stimulation (tVNS), an effective treatment for depression, in reducing risk for NSSI and substance misuse among vulnerable adolescents.


Clinical Trial Description

The overarching goals of the proposed project are threefold. AIM 1: Evaluate the clinical efficacy of tVNS in reducing NSSI and alcohol misuse among vulnerable adolescents. We hypothesize that self-administered tVNS, delivered in 25-minute sessions, will reduce self-reported NSSI and alcohol use, improve adolescents' self-reported emotion regulation, and yield improvements in sympathetic and parasympathetic nervous system markers of emotion regulation and vulnerability to NSSI and alcohol misuse. AIM 2: Evaluate treatment adherence compared with traditional psychosocial interventions of similar duration. We hypothesize that adolescents will demonstrate greater treatment adherence than observed in traditional psychosocial interventions of similar duration, and rate tVNS as acceptable, unobtrusive, and favorable to face-to-face treatment. AIM 3: Evaluate maltreatment effects on tVNS. We hypothesize that tVNS will be effective for those with histories of maltreatment. Although rarely used to date among adolescents, tVNS alters neural and emotional responses to sad stimuli, and among adults, reduces suicide risk up to five years later. At present, it is being evaluated as a treatment for alcohol misuse in a NIH-funded clinical trial. This suggests potential for treating NSSI, alcohol misuse, post-traumatic stress symptoms (PTSS), and other disorders of emotion dysregulation. As outlined above, we will test the efficacy of tVNS in altering behavioral, emotional, and autonomic nervous system risk for NSSI and alcohol misuse, evaluate adherence and acceptability of tVNS among adolescents, and determine if maltreatment histories moderate treatment response. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05343039
Study type Interventional
Source University of Notre Dame
Contact Theodore P Beauchaine, PhD
Phone (574) 631-3910
Email tbeaucha@nd.edu
Status Recruiting
Phase N/A
Start date September 6, 2022
Completion date January 2025

See also
  Status Clinical Trial Phase
Completed NCT03165942 - Neuroendocrine Response to Oral Alcohol Administration Phase 1
Active, not recruiting NCT04070521 - EEG Monitoring in the Emergency Department
Completed NCT03169244 - Buproprion for Binge Drinking Phase 2
Recruiting NCT05246202 - Personalized Feedback Intervention for Latinx Drinkers With Anxiety N/A
Completed NCT05036499 - PFI for Pain-Related Anxiety Among Hazardous Drinkers With Chronic Pain N/A
Recruiting NCT04368416 - Anxiety/Depression, Sleep and Alcohol in Elderly Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints
Not yet recruiting NCT04557631 - Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol
Terminated NCT00890149 - Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults Phase 2
Completed NCT02179749 - Mifepristone Treatment of Alcohol Use Disorder Phase 2
Completed NCT02681406 - Smartphone Based Continuing Care for Alcohol N/A
Completed NCT02448134 - A Community-Based Strategy for Preventing Underage Drinking N/A
Withdrawn NCT01847300 - cSBI-M for Young Military Personnel N/A
Withdrawn NCT01796158 - Pilot Test of Computerized MET to Reduce Adolescent Alcohol Use N/A
Completed NCT01553136 - Varenicline Treatment of Alcohol Dependence in Smokers Phase 2
Withdrawn NCT01511679 - Brain-imaging and Adolescent Neuroscience Consortium N/A
Terminated NCT01408641 - Topiramate for Alcohol Use in Posttraumatic Stress Disorder N/A
Withdrawn NCT01275391 - cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use Phase 1/Phase 2
Active, not recruiting NCT01539525 - Screening to Augment Referral to Treatment- Project START Phase 2
Completed NCT01207258 - Brief Intervention for Problem Drinking and Partner Violence Phase 2
Completed NCT00907309 - Dental and Medical Office iMET to Reduce Teen Tobacco, Alcohol, and Drug Use Phase 1/Phase 2