Evidence map›Paper›PMID 36041704›Full record

Trial reportBrain stimulation

Transcutaneous cervical vagus nerve stimulation reduces behavioral and physiological manifestations of withdrawal in patients with opioid use disorder: A double-blind, randomized, sham-controlled pilot study.

Asim H Gazi, Anna B Harrison, Tamara P Lambert, Malik Obideen, Parvaneh Alavi, Nancy Murrah, Lucy Shallenberger, Emily G Driggers, Rebeca Alvarado Ortega, Brianna P Washington and 9 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Brain stimulation. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04556552 (Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 14% of its field
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.

NCT04556552 phase3completednot on this map

Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders

TypeinterventionalSponsorEmory UniversityRan2020 to 2022Enrolled20ConditionsSubstance-Related Disorders, Substance Use Disorders, Substance Abuse, Intravenous, Substance WithdrawalArmsNon invasive VN stimulation (nVNS), Oxygen (15-O) Water, Sham Stimulation
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Investigating Ultra-Short-Term Heart Rate Variability as an Indicator of Craving in Recently Treated Patients with Opioid Use DisorderAnnual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference · 2024
    Article
  12. Review
  13. Review
  14. Noninvasive Vagal Nerve Stimulation for Opioid Use Disorder.Annals of depression and anxiety · 2023
    Article
  15. Article
  16. Article
  17. Transcutaneous Cervical Vagus Nerve Stimulation Reduces Respiratory Variability in the Context of Opioid Withdrawal.... IEEE-EMBS International Conference on Biomedical and Health Informatics. IEEE-EMBS International Conference on Biomedical and Health Informatics · 2022
    Article
  18. Article
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

19 authors at 4 institutions in 1 country.

Asim H GaziSchool of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA. Electronic address: asim.gazi@gatech.edu.
Anna B HarrisonSchool of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA.
Tamara P LambertCoulter Department of Biomedical Engineering, Georgia Institute of Technology, Atlanta, GA, USA.
Malik ObideenDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, USA.
Parvaneh AlaviDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, USA.
Nancy MurrahDepartment of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
Lucy ShallenbergerDepartment of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
Emily G DriggersDepartment of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
Rebeca Alvarado OrtegaDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, USA.
Brianna P WashingtonDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, USA.
Kevin M WaltonClinical Research Grants Branch, Division of Therapeutics and Medical Consequences, National Institute on Drug Abuse, Bethesda, MD, USA.
Justine W WelshDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, USA.
Viola VaccarinoDepartment of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA; Department of Medicine, Division of Cardiology, Emory University School of Medicine, Atlanta, GA, USA.
Amit J ShahDepartment of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA; Department of Medicine, Division of Cardiology, Emory University School of Medicine, Atlanta, GA, USA; Atlanta Veterans Affairs Health Care System, 1670 Clairmont Road, Decatur, GA, USA.
Yi-Lang TangDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, USA; Atlanta Veterans Affairs Health Care System, 1670 Clairmont Road, Decatur, GA, USA.
Rahul GuptaDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, USA; Atlanta Veterans Affairs Health Care System, 1670 Clairmont Road, Decatur, GA, USA.
Sudie E BackDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.
Omer T InanSchool of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA; Coulter Department of Biomedical Engineering, Georgia Institute of Technology, Atlanta, GA, USA.
J Douglas BremnerDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, USA; Atlanta Veterans Affairs Health Care System, 1670 Clairmont Road, Decatur, GA, USA; Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, GA, USA. Electronic address: jdbremn@emory.edu.
Emory University · USGeorgia Institute of Technology · USMedical University of South Carolina · USNational Institute on Drug Abuse · US

Funding

Vascular Responses During Mental StressP01HL101398 · NHLBI · EMORY UNIVERSITY · PI SHEPS, DAVID SAMUEL · 2010 to 2015
$11.0M
Non-Invasive Vagal Nerve Stimulation in Patients with Opioid Use DisordersUH3DA048502 · NIDA · EMORY UNIVERSITY · PI BREMNER, JAMES DOUGLAS, INAN, OMER TOLGA · 2023 to 2025
$5.8M
Association of Posttraumatic Stress Disorder with Cardiac Electrical Instability: A Twin StudyR01HL155711 · NHLBI · EMORY UNIVERSITY · PI SHAH, AMIT JASVANT · 2021 to 2025
$3.5M
Dopamine function, inflammation and connectivity in PTSDR01MH120262 · NIMH · EMORY UNIVERSITY · PI BREMNER, JAMES DOUGLAS · 2020 to 2023
$2.9M
Biological Correlates of Traumatic StressK24MH076955 · NIMH · EMORY UNIVERSITY · PI BREMNER, JAMES DOUGLAS · 2006 to 2013
$946k
Non-Invasive Vagal Nerve Stimulation in Patients with Opioid Use Disorders UG3DA048502 · NIDA · EMORY UNIVERSITY · PI BREMNER, JAMES DOUGLAS, INAN, OMER TOLGA · 2020 to 2021
$844k
Shared Instrumentation for Research PET Brain DeviceS10RR016917 · NCRR · EMORY UNIVERSITY · PI BREMNER, JAMES DOUGLAS · 2002 to 2002
$500k
CSRD VA I01 CX002331NCRR NIH HHS S10 RR016917NHLBI NIH HHS P01 HL101398NHLBI NIH HHS R01 HL155711NIDA NIH HHS UG3 DA048502NIDA NIH HHS UH3 DA048502NIMH NIH HHS K24 MH076955NIMH NIH HHS R01 MH120262RRD VA I01 RX003418
6 · The paper itself

Abstract

backgroundOpioid Use Disorder (OUD) is a serious public health problem, and the behavioral and physiological effects of opioid withdrawal can be a major impediment to recovery. Medication for OUD is currently the mainstay of treatment; however, it has limitations and alternative approaches are needed.

objectiveThe purpose of this study was to assess the effects of transcutaneous cervical vagus nerve stimulation (tcVNS) on behavioral and physiological manifestations of acute opioid withdrawal.

methodsPatients with OUD undergoing acute opioid withdrawal were randomly assigned to receive double blind active tcVNS (N = 10) or sham stimulation (N = 11) while watching neutral and opioid cue videos. Subjective opioid withdrawal, opioid craving, and anxiety were measured using a Visual Analogue Scale (VAS). Distress was measured using the Subjective Units of Distress Scale (SUDS), and pain was measured using the Numerical Rating Scale (NRS) for pain. Electrocardiogram signals were measured to compute heart rate. The primary outcomes of this initial phase of the clinical trial (ClinicalTrials.gov NCT04556552) were heart rate and craving.

resultstcVNS compared to sham resulted in statistically significant reductions in subjective opioid withdrawal (p = .047), pain (p = .045), and distress (p = .004). In addition, tcVNS was associated with lower heart rate compared to sham (p = .026). Craving did not significantly differ between groups (p = .11).

conclusionstcVNS reduces behavioral and physiological manifestations of opioid withdrawal, and should be evaluated in future studies as a possible non-pharmacologic, easily implemented approach for adjunctive OUD treatment.

Indexed as

Opioid-Related DisordersSubstance Withdrawal SyndromeVagus Nerve StimulationAnalgesics, OpioidHumansPainPilot ProjectsTreatment OutcomeAnalgesics, OpioidDouble-blindNon-invasiveOpioid use disorderSham-controlledVagus nerve stimulationWithdrawal

Identifiers

PMID36041704
PMCPMC9588751
OpenAlexW4293340110

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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 OpenQuestion graph.