Alcohol Abuse Clinical Trial
— TEAMOfficial title:
Leveraging Biomarkers and New Technologies to Reduce Self-Injury and Substance Abuse Risk Among Highly Vulnerable Adolescents
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | January 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 17 Years |
Eligibility | Inclusion Criteria: - Have used alcohol - Have engaged in = 3 episodes of NSSI in the past 6 months or = 5 lifetime (1 of these 5 must be in the past year) - Own a smartphone (iPhone or Android) Exclusion Criteria: - Autism - Schizophrenia - Have a cardiac pacemaker, implanted defibrillator, or implanted or metallic electronic device - Pregnant or breastfeeding - Have a history of seizures or epilepsy - Temperomandibular Joint Disorder - Bell's Palsy - Impaired cranial nerve function or facial pain |
Country | Name | City | State |
---|---|---|---|
United States | University of Notre Dame | South Bend | Indiana |
Lead Sponsor | Collaborator |
---|---|
University of Notre Dame |
United States,
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* Note: There are 118 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in Non-suicidal Self Injury and Alcohol Misuse Behaviors at Day 30 | Participants will engage in 25-minute tVNS sessions daily. | 30 days | |
Primary | Maintenance of Treatment Effects at 3 Months Post Intervention | Participants will be evaluated on the maintenance of any such treatment effects 3 months post intervention. | 3 months | |
Primary | Change from Baseline in Emotion Regulation at Day 30 | Participants will complete a 2-3 minute survey daily in which they are to report on different feelings and emotions such as happiness, sadness, and anger. | 30 days | |
Secondary | Adherence to tVNS Intervention from Baseline to Day 30 | Adherence of participants' self-administered daily 25-minute tVNS sessions will be measured from participants' tVNS phone app. They will also report on acceptability, obtrusiveness, and favorability of tVNS. | 30 days |
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