MedTrace Logo

Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder

NCT05053503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-07-04

No results posted yet for this study

Summary

The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II.

Conditions

  • Opioid-use Disorder
  • Opioid Withdrawal

Interventions

DEVICE

Sparrow Ascent Therapy System

Transcutaneous auricular neurostimulation (tAN)

DRUG

Lofexidine

Participants will receive 3 lofexidine 0.18 mg/tablets four times per day (daily dose of 2.16 mg) for 7 days.

DRUG

Extended-release injectable naltrexone

Participants will receive extended-release injectable naltrexone based on the clinical site's standard of care.

Sponsors & Collaborators

  • Hazelden Betty Ford Foundation

    collaborator UNKNOWN

  • Gaudenzia, Inc.

    collaborator UNKNOWN

  • Spark Biomedical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2022-05-27
Primary Completion
2025-04-04
Completion
2025-04-04
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05053503 on ClinicalTrials.gov