Studies
Study First Submitted Date | 2019-11-05 |
Study First Posted Date | 2019-11-12 |
Last Update Posted Date | 2023-04-12 |
Start Month Year | January 31, 2024 |
Primary Completion Month Year | September 30, 2024 |
Verification Month Year | April 2023 |
Verification Date | 2023-04-30 |
Last Update Posted Date | 2023-04-12 |
Detailed Descriptions
Sequence: | 20688587 |
Description | The management of acute alcohol withdrawal is a clinical challenge, in part because there are limited medications available for the condition and the majority of the medications are controlled substances, which may cause significant adverse effects and can be potentially addictive.
The rationale for using transcutaneous auricular VNS (taVNS) on a specific target area of the ear is based on anatomical studies suggesting that this area is the only place on the human body surface where there is afferent vagus nerve distribution (Mercante et al., 2018). Therefore, direct stimulation of the afferent nerve fibers on the ear can produce an effect similar to that by implanted device-generated VNS yet without the need of surgical intervention. Although taVNS has not been tested for treatment of AUD, it interestingly appears to be very similar to auricular acupuncture that has been widely used for AUD. However, acupuncture needs to be administered by medical providers who have undergone long trainings and own special licensure, which is usually unavailable in acute detoxification units where patients receive treatment for acute alcohol withdrawal. The pilot study will enroll 70 evaluable subjects who are in inpatient detoxification unit randomized to receive single-blind treatment with vagus nerve stimulation or sham stimulation (1:1, VNS: sham). Evaluable subjects are those who complete stimulations (VNS) or sham 5 minutes twice a day for 4 days. |
Facilities
Sequence: | 199692280 |
Name | Feinstein Institutes for Medical Research, Northwell Health |
City | Manhasset |
State | New York |
Zip | 11030 |
Country | United States |
Facility Contacts
Sequence: | 28067245 | Sequence: | 28067246 |
Facility Id | 199692280 | Facility Id | 199692280 |
Contact Type | primary | Contact Type | backup |
Name | Andrew C Chen, MD, PhD | Name | Valentin A Pavlov, PhD |
achen4@northwell.edu | vpavlov@northwell.edu | ||
Phone | 516-837-1681 | Phone | 5165622316 |
Conditions
Sequence: | 52082952 | Sequence: | 52082953 |
Name | Alcohol Withdrawal | Name | Alcohol Use Disorder |
Downcase Name | alcohol withdrawal | Downcase Name | alcohol use disorder |
Id Information
Sequence: | 40088318 |
Id Source | org_study_id |
Id Value | 19-0576 |
Countries
Sequence: | 42488044 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55496914 | Sequence: | 55496915 |
Group Type | Experimental | Group Type | Sham Comparator |
Title | VNS transcutaneous stimulation | Title | Sham stimulation |
Description | 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. |
Description | 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. |
Interventions
Sequence: | 52396123 | Sequence: | 52396124 |
Intervention Type | Device | Intervention Type | Device |
Name | Transcutaneous Nerve Stimulation | Name | Sham Stimulation |
Description | 510(K) number: K110390 vagus nerve for 5 minutes twice a day for 4 consecutive days | Description | sham stimulation (no electrical current) for 5 minutes twice a day for 4 consecutive days |
Keywords
Sequence: | 79723013 |
Name | vagus nerve stimulation (VNS), non-invasive intervention |
Downcase Name | vagus nerve stimulation (vns), non-invasive intervention |
Design Outcomes
Sequence: | 177079062 | Sequence: | 177079063 |
Outcome Type | primary | Outcome Type | other |
Measure | The primary clinical outcome is the reduction of the alcohol withdrawal symptoms assessed by the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) | Measure | Assesssment of change of neruroinflammatory reflex by measurement of blood levels of cytokines following VNS treatment for acute alcohol withdrawal |
Time Frame | 3 months after completion of pilot study (enrollment) | Time Frame | 6 months after completion of pilot study (enrollment) |
Description | 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. | Description | The mechanistic endpoints accompanying this protocol will evaluate potential effects of VNS on inflammatory markers and cytokines known to be involved with AUD. 8 ml venous whole blood from participants will be collected on Day 1 before receiving any VNS or sham treatment and on Day 5 after completing all 8 treatments. Serum and plasma from 8cc of whole blood will be collected, stored in aliquots at -20∙C. Serum levels of potential inflammatory markers and markers regulated by the alpha-7nAChR will be determined, including levels of pro-inflammatory cytokines, TNF, HMGB1, IL-6, Il1B, IFNα and IL10 which are known to be elevated in patients with AUD. |
Browse Conditions
Sequence: | 193136040 | Sequence: | 193136041 | Sequence: | 193136042 | Sequence: | 193136043 | Sequence: | 193136044 |
Mesh Term | Alcoholism | Mesh Term | Alcohol-Related Disorders | Mesh Term | Substance-Related Disorders | Mesh Term | Chemically-Induced Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | alcoholism | Downcase Mesh Term | alcohol-related disorders | Downcase Mesh Term | substance-related disorders | Downcase Mesh Term | chemically-induced disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48237606 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Northwell Health |
Overall Officials
Sequence: | 29233798 |
Role | Principal Investigator |
Name | Andrew C Chen, MD, PhD |
Affiliation | Northwell Health |
Central Contacts
Sequence: | 11990499 | Sequence: | 11990500 |
Contact Type | primary | Contact Type | backup |
Name | Andrew C Chen, MD, PhD | Name | Valentin A Pavlov, PhD |
Phone | 5168371681 | Phone | 5165622316 |
achen4@northwell.edu | VPavlov@northwell.edu | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68032062 | Sequence: | 68032063 |
Design Group Id | 55496914 | Design Group Id | 55496915 |
Intervention Id | 52396123 | Intervention Id | 52396124 |
Eligibilities
Sequence: | 30714176 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
age 18-65 years (men and women); Exclusion Criteria: current DSM-V substance use disorders (other than tobacco / cannabis/ alcohol); |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253946022 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30460744 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Intervention Model Description | Randomized, single-blinded Treatment vs sham |
Subject Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28827205 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 51979225 | Sequence: | 51979226 | Sequence: | 51979227 | Sequence: | 51979228 |
Pmid | 29937968 | Pmid | 22891061 | Pmid | 28051842 | Pmid | 2597811 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | 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. | Citation | 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. | Citation | 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. | Citation | 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. |