Clinical Trials Logo
  1. Home
  2. Opioid-use Disorder
  3. NCT04731935

Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal

Opioid-use Disorder Clinical Trial

Official title:
A Pilot Study to Evaluate Safety and Efficacy of a Novel Electrode Configuration for Delivering Transcutaneous Auricular Neurostimulation to Improve Symptoms Associated With Opioid Withdrawal

Clinical Trial Summary

The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.

Clinical Trial Description

This study is designed as a pilot, single-center, non-randomized, uncontrolled, clinical trial in which subjects will be consented, receive a baseline assessment, and receive tAN treatment and assessment every day during their 3 to 5-day detox treatment. Use of opioid-based medication assisted therapy (MAT) will not be permitted at any point during the study. Use of non-opioid-based MATs (i.e. comfort or rescue medications) will not be permitted until after the subject has completed the 60 minute COWS assessment to ensure changes in COWS score at 60 minutes are only the result of tAN therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04731935
Study type Interventional
Source Spark Biomedical, Inc.
Contact
Status Completed
Phase N/A
Start date March 18, 2021
Completion date May 26, 2021
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04157062 - An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder N/A
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Completed NCT04505540 - Start Treatment and Recovery for Opioid Use Disorder N/A
Completed NCT03065049 - Transforming Recovery Through Exercise and Community N/A
Completed NCT04080037 - Assessing Opioid Care Practices Using CPV Patient Simulation Modules N/A
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Suspended NCT05001789 - Cognitive Functioning in Opioid Use Disorder N/A
Active, not recruiting NCT04650386 - Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients N/A
Completed NCT03715634 - Study of a Novel Subcutaneous Depot Formulation of Buprenorphine Phase 1
Enrolling by invitation NCT04991974 - Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine Phase 2/Phase 3
Completed NCT04122755 - Single Ascending Dose Study of ALA-1000 Phase 1
Recruiting NCT05049460 - Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder N/A
Recruiting NCT04927143 - Encouraging Abstinence Behavior in a Drug Epidemic Phase 2
Recruiting NCT05028998 - COVID-19-Related Opioid Treatment Policy Evaluation
Completed NCT05047627 - Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder N/A
Active, not recruiting NCT04129580 - reSET-O RCT (Randomized Controlled Trial) N/A
Recruiting NCT03923374 - Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Completed NCT04464421 - SMART Effectiveness Trial N/A
Completed NCT04056182 - Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment Phase 2
Suspended NCT02687360 - Imaging the Effects of rTMS on Chronic Pain N/A