NCT05053503View on ClinicalTrials.gov

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

NACompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

May 27, 2022

Primary Completion Date

April 4, 2025

Study Completion Date

April 4, 2025

Conditions
Opioid-use DisorderOpioid 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.

Trial Locations (4)

21032

Gaudenzia, Inc., Crownsville

55012

Hazelden Betty Ford Foundation, Center City

55441

Hazelden Betty Ford Foundation, Plymouth

92270

Hazelden Betty Ford Foundation, Rancho Mirage

All Listed Sponsors
collaborator

Hazelden Betty Ford Foundation

UNKNOWN

collaborator

Gaudenzia, Inc.

UNKNOWN

lead

Spark Biomedical, Inc.

INDUSTRY