Evidence map›Paper›PMID 41003459›Full record

Trial reportNeuromodulation : journal of the International Neuromodulation Society2025

Noninvasive Vagus Nerve Stimulation Reduces Withdrawal-Related Affective Distress and Improves Functional Outcomes in Alcohol Use Disorder: A Feasibility and Acceptability Pilot Study.

Ruth Klaming, Katia M Harlé, Imanuel R Lerman, Sonya B Norman, Irina A Strigo, Alan N Simmons, Andrea D Spadoni

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neuromodulation : journal of the International Neuromodulation Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Ruth KlamingVA Healthcare System, San Diego, CA, USA; Department of Psychiatry, University of California, San Diego, San Diego, CA, USA. Electronic address: rklaming@health.ucsd.edu.
Katia M HarléVA Healthcare System, San Diego, CA, USA; Department of Psychiatry, University of California, San Diego, San Diego, CA, USA.
Imanuel R LermanVA Healthcare System, San Diego, CA, USA; Department of Anesthesiology, University of California, San Diego, San Diego, CA, USA.
Sonya B NormanVA Healthcare System, San Diego, CA, USA; Department of Psychiatry, University of California, San Diego, San Diego, CA, USA.
Irina A StrigoEmotion and Pain Laboratory and VA Advanced Imaging Research Center, San Francisco Veterans Affairs Health Care Center, San Francisco, CA, USA; Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA.
Alan N SimmonsVA Healthcare System, San Diego, CA, USA; Department of Psychiatry, University of California, San Diego, San Diego, CA, USA.
Andrea D SpadoniVA Healthcare System, San Diego, CA, USA; Department of Psychiatry, University of California, San Diego, San Diego, CA, USA.

Funding

CSRD VA I01 CX002397CSRD VA IK6 CX002926RRD VA IK1 RX003629RRD VA IK2 RX004777
6 · The paper itself

Abstract

objectivesAlcohol use disorder (AUD) is characterized by autonomic dysregulation and overactive brain stress systems, which manifests as pronounced negative emotional states in the absence of alcohol and can lead to functional impairment. The vagus nerve presents a promising novel treatment target for these symptoms. The aim of this pilot study was to evaluate the feasibility and acceptability of cervical noninvasive vagal nerve stimulation (nVNS) as a new treatment for AUD, and to assess whether nVNS can alleviate withdrawal-related affective distress and improve functional outcomes. MATERIALS AND

methodsIn this double-blind, randomized controlled trial, male Veterans with AUD were randomly assigned to receive active (n = 9) or sham (n = 10) nVNS at baseline, self-administered stimulation for seven days, and returned for a follow-up visit. Treatment adherence and acceptability ratings were assessed. Behavioral self-report measures of affective distress (Patient Health Questionnaire [PHQ-8], State-Trait Anxiety Inventory-State, Beck Anxiety Inventory) and functional limitations (Drinker Inventory of Consequences [DrInC-2R], Brief Inventory of Psychosocial Functioning [BIPF]) were collected at baseline and follow-up. Linear mixed effects (LME) models were used to assess the impact of treatment group on outcome measures.

resultsTreatment adherence was high in both groups and did not statistically differ (94% nVNS group, 80% sham group; p = 0.14). Both groups assigned treatment acceptability ratings in the acceptable to highly acceptable range. LME results show significant group-by-time interactions for the PHQ-8 [p = 0.04], DrInC-2R [p = 0.02], and BIPF [p = 0.01]), indicating greater reductions in depressive symptoms, adverse alcohol-related consequences, and functional limitations after nVNS than with sham treatment. No statistically significant group-by-time interactions were observed for anxiety symptoms.

conclusionsTo our knowledge, this is the first study to explore cervical nVNS as a potential new treatment for AUD-related symptoms. Findings provide support for feasibility of treatment delivery and patient acceptance, and initial evidence that nVNS can achieve significant reductions in depressive symptoms in addition to adverse alcohol-related consequences and psychosocial functional limitations in AUD.

Indexed as

AlcoholismPatient Acceptance of Health CareSubstance Withdrawal SyndromeVagus Nerve StimulationAdultDouble-Blind MethodFeasibility StudiesHumansMaleMiddle AgedPilot ProjectsTreatment OutcomeVeteransAlcohol use disordercervical nVNSfunctional outcomesnoninvasive vagal nerve stimulationwithdrawal-related affective distress

Identifiers

PMID41003459
PMCPMC12951849

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.