What side effects are associated with this type of intervention?

Common treatments for alcoholism include medications like naltrexone, acamprosate, and disulfiram, as well as behavioral therapies. Naltrexone can cause side effects such as nausea, headache, dizziness, and fatigue. Acamprosate may lead to diarrhea, anxiety, and insomnia. Disulfiram can cause drowsiness, headache, and a metallic taste, and it can lead to severe reactions if alcohol is consumed. Transcutaneous Vagus Nerve Stimulation (tVNS), while primarily studied for depression and other conditions, may cause mild side effects like skin irritation, headache, and dizziness. Overall, these treatments aim to reduce alcohol cravings and support abstinence, but they come with varying side effect profiles.

What prior FDA approvals exist?

FDA-approved treatments for alcoholism include medications such as disulfiram, naltrexone, and acamprosate, which help reduce cravings and prevent relapse. While these medications work through different biochemical pathways, neuromodulation techniques like transcutaneous vagus nerve stimulation (tVNS) are being studied for their potential to reduce symptoms of depression, nonsuicidal self-injury (NSSI), and substance misuse, including alcohol. tVNS is a noninvasive method that stimulates the vagus nerve and may offer a novel approach to treating alcoholism by addressing underlying neuropsychiatric conditions.

What other types of research exist?

Promising novel alternatives to tVNS for treating alcoholism in 2024 include Deep Brain Stimulation (DBS) and Spinal Cord Stimulation (SCS). DBS has shown efficacy in treatment-refractory conditions like OCD and may offer benefits for substance misuse. SCS has been effective in managing chronic pain and could potentially address underlying issues contributing to alcoholism. Both therapies are invasive but have demonstrated significant potential in neuromodulation for various conditions.

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Behavioural Intervention

tVNS for Self-Harm and Substance Misuse (TEAM Trial)

N/A

Recruiting

Led By Brooke A Ammerman, PhD

Research Sponsored by University of Notre Dame

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

TEAM Trial Summary

This trial will study whether a noninvasive treatment for depression, transcutaneous vagus nerve stimulation (tVNS), is effective in reducing risk for nonsuicidal self-injury (NSSI) and substance misuse among vulnerable adolescents.

Who is the study for?

This trial is for adolescents who have self-harmed at least three times in the past six months or five times in their life, with one incident within the last year. They must also have used alcohol and own a smartphone. It's not suitable for those with autism, schizophrenia, cardiac devices, pregnancy, seizure history, Bell's Palsy, cranial nerve issues or TMJ disorder.Check my eligibility

What is being tested?

The TEAM trial is testing non-invasive transcutaneous vagus nerve stimulation (tVNS) as a potential low-cost treatment to reduce risks of nonsuicidal self-injury and substance misuse among vulnerable adolescents compared to no intervention.See study design

What are the potential side effects?

While tVNS is generally considered safe, potential side effects may include mild discomfort at the site of stimulation, headache, fatigue or slight dizziness. However specific side effects related to this study are not detailed.

TEAM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Emotion Regulation at Day 30

Change from Baseline in Non-suicidal Self Injury and Alcohol Misuse Behaviors at Day 30

Maintenance of Treatment Effects at 3 Months Post Intervention

Secondary outcome measures

Adherence to tVNS Intervention from Baseline to Day 30

TEAM Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

Participants will receive a tVNS device.

Group II: Non-Treatment GroupExperimental Treatment1 Intervention

Participants will not receive a tVNS device.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

No Intervention

2017

Completed Phase 1

~4810

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for alcoholism often involve neuromodulation techniques such as Transcutaneous Vagus Nerve Stimulation (tVNS), which stimulates the vagus nerve to potentially reduce symptoms of depression, nonsuicidal self-injury (NSSI), and substance misuse. This is significant for alcoholism patients as it addresses underlying psychological factors that contribute to alcohol dependence. By modulating neural circuits associated with mood and reward, these treatments can help reduce cravings and improve emotional regulation, thereby supporting recovery and reducing relapse rates.

The effects of ethanol upon threshold and response rate for self-stimulation.Interactions between TRH and ethanol in the medial septum.Effects of the hallucinogenic beverage ayahuasca on voluntary ethanol intake by rats and on cFos expression in brain areas relevant to drug addiction.

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Who is running the clinical trial?

University of Notre DameLead Sponsor

33 Previous Clinical Trials

61,544 Total Patients Enrolled

Brooke A Ammerman, PhDPrincipal InvestigatorUniversity of Notre Dame

Kristin Valentino, PhDPrincipal InvestigatorUniversity of Notre Dame

Media Library

Non-invasive Transcutaneous Nerve Stimulation (tVNS) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05343039 — N/A

Alcoholism Research Study Groups: Treatment Group, Non-Treatment Group

Alcoholism Clinical Trial 2023: Non-invasive Transcutaneous Nerve Stimulation (tVNS) Highlights & Side Effects. Trial Name: NCT05343039 — N/A

Non-invasive Transcutaneous Nerve Stimulation (tVNS) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05343039 — N/A

~11 spots leftby Jan 2025

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