Using Transcutaneous Auricular Vagus Nerve Stimulation to Treat Acute Alcohol Withdrawal

NCT04159909 | Withdrawn DMC FDA Device

• 1 other identifier: 19-0576
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if stimulation of the vagus nerve via a non-invasive device placed behind external ear can reduce physical and psychological discomfort during acute alcohol withdrawal in patients with alcohol use disorder when people just stop drinking alcohol and in detoxification stage.

Conditions

Alcohol Withdrawal; Alcohol Use Disorder

Keywords

vagus nerve stimulation (VNS), non-invasive intervention

Outcome Measures

Primary Outcomes (1)

• The primary clinical outcome is the reduction of the alcohol withdrawal symptoms assessed by the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar)

  The primary clinical endpoint is the alcohol withdrawal symptoms assessed by the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) (Sullivan, Sykora, Schneiderman, Naranjo, \& Sellers, 1989) as well as the amount and frequency of as needed comfort medications (benzodiazepines, e.g., Chlordiaxepoxide, Lorazepam) used from day 1 to day 4 by the participants in acute detoxification inpatient unit treated with VNS compared to subjects receiving sham stimulation.

  3 months after completion of pilot study (enrollment)

Other Outcomes (1)

• Assesssment of change of neruroinflammatory reflex by measurement of blood levels of cytokines following VNS treatment for acute alcohol withdrawal

  6 months after completion of pilot study (enrollment)

Study Arms (2)

VNS transcutaneous stimulation

EXPERIMENTAL

5 minutes of stimulation (VNS) twice a day for 4 days. Patients will receive transcutaneous stimulation (30 Hz, 300 msec.) on the auricular branch of the vagus nerve 5 minutes twice a day for 4 days. Due to the theoretical risk that right vagus nerve stimulation could affect the heart, and to ensure consistency of the intervention, all subjects randomized to receive transcutaneous vagus nerve stimulation will receive stimulation of the auricular branch of the left vagus nerve. The subject will be blinded to their treatment arm. The device to be used will include a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve, which innervates the skin of a specific ear area termed "Cymba Concha". Electrodes will be placed on this area to provide stimulation to the auricular branch of the afferent vagus nerve.

Device: Transcutaneous Nerve Stimulation

Sham stimulation

SHAM COMPARATOR

5 minutes of sham stimulation (no electrical stimulation) twice a day for 4 days Patients will receive sham stimulation on the auricular branch of the vagus nerve 5 minutes twice a day for 4 days. The subject will be blinded to their treatment arm. The specific target at the ear will be the auricular branch of the vagus nerve, which innervates the skin of a specific ear area termed "Cymba Concha". Electrodes will be placed on this area to provide sham stimulation (no electrical current) to the auricular branch of the afferent vagus nerve.

Device: Sham Stimulation

Interventions

Transcutaneous Nerve Stimulation DEVICE

510(K) number: K110390 vagus nerve for 5 minutes twice a day for 4 consecutive days

VNS transcutaneous stimulation

Sham Stimulation DEVICE

sham stimulation (no electrical current) for 5 minutes twice a day for 4 consecutive days

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-65 years (men and women);
• primary current diagnosis of DSM-V Alcohol Use Disorder as indicated at admission;
• being admitted to inpatient detoxification unit;
• no evidence of significant cognitive impairment with a mini mental state examination (MMSE; Folstein et al., 1975) score \> 22;
• able and willing to give written informed consent and comply with the requirements of the study protocol.

You may not qualify if:

• current DSM-V substance use disorders (other than tobacco / cannabis/ alcohol);
• serious psychiatric illnesses, e.g. psychotic disorders or bipolar disorder
• severe medical illnesses, present or history of, e.g. hepatic encephalopathy, delirium
• history of significant medical problems associated with drinking including seizures;
• pregnancy;
• severe intellectual/cognitive deficits due to Korsakoff's syndrome, dementia, head injury, or others
• treatment with an anti-cholinergic medication, including over the counter medications,
• implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Feinstein Institutes for Medical Research, Northwell Health

Manhasset, New York, 11030, United States

Location

Related Publications (4)

• Mercante B, Ginatempo F, Manca A, Melis F, Enrico P, Deriu F. Anatomo-Physiologic Basis for Auricular Stimulation. Med Acupunct. 2018 Jun 1;30(3):141-150. doi: 10.1089/acu.2017.1254.

  PMID: 29937968 BACKGROUND

• Kreuzer PM, Landgrebe M, Husser O, Resch M, Schecklmann M, Geisreiter F, Poeppl TB, Prasser SJ, Hajak G, Langguth B. Transcutaneous vagus nerve stimulation: retrospective assessment of cardiac safety in a pilot study. Front Psychiatry. 2012 Aug 7;3:70. doi: 10.3389/fpsyt.2012.00070. eCollection 2012.

  PMID: 22891061 BACKGROUND

• Baker TE, Chang G. The use of auricular acupuncture in opioid use disorder: A systematic literature review. Am J Addict. 2016 Dec;25(8):592-602. doi: 10.1111/ajad.12453. Epub 2016 Nov 2.

  PMID: 28051842 BACKGROUND

• Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x.

  PMID: 2597811 BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Andrew C Chen, MD, PhD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, single-blinded Treatment vs sham

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 12, 2019
• Study Start: January 31, 2024
• Primary Completion: September 30, 2024
• Study Completion: January 30, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)