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

Completed · Not applicable · Has a placebo group

Conditions studied: Opioid-use Disorder, Opioid Withdrawal

In brief

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.

Key facts

Study ID

NCT05053503

Run by

Spark Biomedical, Inc.

People needed

108

Starts

2022-05-27

Expected to finish

2025-04-04

Last updated by the study team

2025-07-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant shows signs of current opioid dependence; prescription or non-prescription
• Participant COWS score is ≥ 8 or in the opinion of the investigator the participant is in mild to moderate withdrawal at the baseline assessment
• Participant is between 18 and 65 years of age
• Participant is English proficient
• Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements

You may not qualify if…

• Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
• Participant has a history of epileptic seizures
• Participant has a history of neurological diseases or traumatic brain injury
• Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment
• Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
• Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators
• Participant has abnormal ear anatomy or ear infection present
• Participant is unwilling to transition to opioid antagonist medication following acute detox treatment
• Subject has significant current suicidal ideation within 30 days prior to Screening as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening, that, in the opinion of the investigator, warrants exclusion from the trial
• Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
• Females who are pregnant or lactating
• Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Where it is running

• Hazelden Betty Ford Foundation — Rancho Mirage, California, United States
• Gaudenzia, Inc. — Crownsville, Maryland, United States
• Hazelden Betty Ford Foundation — Center City, Minnesota, United States
• Hazelden Betty Ford Foundation — Plymouth, Minnesota, United States

Full record on ClinicalTrials.gov

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