Substance Use Disorder (SUD) / Transcutaneous Auricular Vagus Nerve Stimulation · Interventional Study

Auricular Vagal Neuromodulation for Depression and Anxiety in Substance Use Disorder

ClinicalTrials.gov · September 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered, not-yet-recruiting pilot study of transcutaneous auricular vagus nerve stimulation (AVNT) in adults with substance use disorder. The primary objectives are to evaluate recruitment, retention, adherence, and device tolerability over 30 days; depression and anxiety outcomes are exploratory. No results are posted in this registry record.

What was studied

Interventional, Single Group, Open label, Treatment purpose. Substance Use Disorder (SUD); age from 18 Years; to 60 Years. Intervention: AVNT Intervention. n = 50. 1 site: United States.

Key findings

Safety

Phase designation listed as 'NA'; unclear whether this precedes or parallels Phase 1 or Phase 2 safety work.

Who this may help

This pilot study is not yet recruiting and has no posted efficacy results; it is designed to assess feasibility and tolerability, not to support clinical recommendations. Readers should monitor for results when published to assess whether home-based AVNT warrants further investigation in this population.

Plain-language summary

This is a pilot feasibility and tolerability study not yet recruiting, with no posted results; it measures device acceptability and adherence, not clinical efficacy.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Recruitment Rate (assessed at From enrollment to the end of treatment at 30 days); Retention Rate (assessed at From enrollment to the end of treatment at 30 days); Study Completion Rate (assessed at From enrollment to the end of treatment at 30 days); Adherence to AVNT Device Use (assessed at From enrollment to the end of treatment at 30 days); Participant-Reported Tolerability of AVNT Using the AVNT Tolerability Assessment (assessed at From enrollment to the end of treatment at 30 days); Device Return Rate (assessed at From enrollment to the end of treatment at 30 d…

DesignInterventional, Single Group, Open label, Treatment purpose

PopulationSubstance Use Disorder (SUD); age from 18 Years; to 60 Years

Sample size50

InterventionAVNT Intervention

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment50

Study duration30 days

Daily device use targetapproximately 60 minutes

Primary outcome measure 1Recruitment Rate (enrollment to end of treatment at 30 days)

Primary outcome measure 2Retention Rate (enrollment to end of treatment at 30 days)

Primary outcome measure 3Study Completion Rate (enrollment to end of treatment at 30 days)

Primary outcome measure 4Adherence to AVNT Device Use (enrollment to end of treatment at 30 days)

Primary outcome measure 5Participant-Reported Tolerability of AVNT Using the AVNT Tolerability Assessment (enrollment to end of treatment at 30 days)

Clinical bottom line

Caveats

No results reported in this registry record; study status is NOT_YET_RECRUITING.
Single-arm design with no control group; cannot attribute any clinical changes to the device.
Depression and anxiety are exploratory outcomes, not primary; no effect size targets or statistical power stated.
Phase designation listed as 'NA'; unclear whether this precedes or parallels Phase 1 or Phase 2 safety work.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Single-arm pilot design appropriate for feasibility; no control comparator stated.

Directness

limited

Primary endpoints are recruitment, retention, and tolerability; depression and anxiety are exploratory only.

Consistency

insufficient

No results posted; registry record does not report findings or comparisons.

Risk of bias

insufficient

Study not yet recruiting; no blinding, allocation concealment, or outcome adjudication detailed.

Sample adequacy

limited

50 participants estimated; appropriate for pilot feasibility, underpowered for clinical efficacy claims.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07814755). This is a study registration, not published results. Lead sponsor: Daisy Thompson-Lake. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 50 participants (ESTIMATED). Conditions: Substance Use Disorder (SUD). Interventions: DEVICE: Transcutaneous Auricular Vagus Nerve Stimulation. Primary outcome measures: Recruitment Rate , From enrollment to the end of treatment at 30 days; Retention Rate , From enrollment to the end of treatment at 30 days; Study Completion Rate , From enrollment to the end of treatment at 30 days; Adherence to AVNT Device Use , From enrollment to the end of treatment at 30 days; Participant-Reported Tolerability of AVNT Using the AVNT Tolerability Assessment , From enrollment to the end of treatment at 30 days; Device Return Rate , From enrollment to the end of treatment at 30 days. Brief summary: This pilot study will evaluate whether home-based auricular vagal neuromodulation therapy (AVNT) is practical, acceptable, and well tolerated for adults receiving treatment for substance use disorder. Participants will use a handheld device that delivers mild electrical stimulation to the ear for approximately 60 minutes each day over 30 days. Researchers will examine whether participants can successfully use the device as directed and complete study procedures. The study will also explore whether use of the device is associated with changes in depression, anxiety, sleep problems, and substance craving.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Daisy Thompson-LakeSubstance Use Disorder (SUD)Transcutaneous Auricular Vagus Nerve StimulationNCT07814755