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Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal

NCT04075214 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-08-19

No results posted yet for this study

Summary

Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal in order to support clinical substantial equivalence to a predicate device.

Conditions

  • Opioid-use Disorder
  • Opioid Withdrawal

Interventions

DEVICE

transcutaneous auricular neurostimulation (tAN)

Phoenix tAN system

Sponsors & Collaborators

  • Spark Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Navid Khodaparast, PhD · Spark Biomedical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-19
Primary Completion
2020-12-14
Completion
2020-12-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04075214 on ClinicalTrials.gov