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
Background: Opioid 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 nee...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-09-01
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| Series: | Brain Stimulation |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1935861X22001954 |
| _version_ | 1798019806309384192 |
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| author | 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 Kevin M. Walton Justine W. Welsh Viola Vaccarino Amit J. Shah Yi-Lang Tang Rahul Gupta Sudie E. Back Omer T. Inan J. Douglas Bremner |
| author_facet | 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 Kevin M. Walton Justine W. Welsh Viola Vaccarino Amit J. Shah Yi-Lang Tang Rahul Gupta Sudie E. Back Omer T. Inan J. Douglas Bremner |
| author_sort | Asim H. Gazi |
| collection | DOAJ |
| description | Background: Opioid 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. Objective: The 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. Methods: Patients 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. Results: tcVNS 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). Conclusions: tcVNS 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. |
| first_indexed | 2024-04-11T16:46:50Z |
| format | Article |
| id | doaj.art-09d563ad90524a5f9f2922735fbd8670 |
| institution | Directory Open Access Journal |
| issn | 1935-861X |
| language | English |
| last_indexed | 2024-04-11T16:46:50Z |
| publishDate | 2022-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Brain Stimulation |
| spelling | doaj.art-09d563ad90524a5f9f2922735fbd86702022-12-22T04:13:32ZengElsevierBrain Stimulation1935-861X2022-09-0115512061214Transcutaneous cervical vagus nerve stimulation reduces behavioral and physiological manifestations of withdrawal in patients with opioid use disorder: A double-blind, randomized, sham-controlled pilot studyAsim H. Gazi0Anna B. Harrison1Tamara P. Lambert2Malik Obideen3Parvaneh Alavi4Nancy Murrah5Lucy Shallenberger6Emily G. Driggers7Rebeca Alvarado Ortega8Brianna P. Washington9Kevin M. Walton10Justine W. Welsh11Viola Vaccarino12Amit J. Shah13Yi-Lang Tang14Rahul Gupta15Sudie E. Back16Omer T. Inan17J. Douglas Bremner18School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA; Corresponding author. School of Electrical and Computer Engineering, Georgia Institute of Technology, 777 Atlantic Dr NW, Atlanta, GA, 30332, USA.School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USACoulter Department of Biomedical Engineering, Georgia Institute of Technology, Atlanta, GA, USADepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, USADepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, USADepartment of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USADepartment of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USADepartment of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USADepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, USADepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, USAClinical Research Grants Branch, Division of Therapeutics and Medical Consequences, National Institute on Drug Abuse, Bethesda, MD, USADepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, USADepartment 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, USADepartment 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, USADepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, USA; Atlanta Veterans Affairs Health Care System, 1670 Clairmont Road, Decatur, GA, USADepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, USA; Atlanta Veterans Affairs Health Care System, 1670 Clairmont Road, Decatur, GA, USADepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USASchool of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA; Coulter Department of Biomedical Engineering, Georgia Institute of Technology, Atlanta, GA, USADepartment 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; Corresponding author. Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, USA.Background: Opioid 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. Objective: The 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. Methods: Patients 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. Results: tcVNS 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). Conclusions: tcVNS 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.http://www.sciencedirect.com/science/article/pii/S1935861X22001954Opioid use disorderWithdrawalNon-invasiveVagus nerve stimulationSham-controlledDouble-blind |
| spellingShingle | 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 Kevin M. Walton Justine W. Welsh Viola Vaccarino Amit J. Shah Yi-Lang Tang Rahul Gupta Sudie E. Back Omer T. Inan J. Douglas Bremner 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 Brain Stimulation Opioid use disorder Withdrawal Non-invasive Vagus nerve stimulation Sham-controlled Double-blind |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Opioid use disorder Withdrawal Non-invasive Vagus nerve stimulation Sham-controlled Double-blind |
| url | http://www.sciencedirect.com/science/article/pii/S1935861X22001954 |
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