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

Completed · Not applicable

Conditions studied: Opioid-use Disorder, Opioid Withdrawal

In brief

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.

Key facts

Study ID

NCT04731935

Run by

Spark Biomedical, Inc.

People needed

6

Starts

2021-03-18

Expected to finish

2021-05-26

Last updated by the study team

2021-08-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Current opioid dependence; prescriptive or non-prescriptive
• COWS score is ≥ 13 or in the opinion of the investigator the subject is in moderate to severe withdrawal
• 18-65 years of age
• English proficiency
• Participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements

You may not qualify if…

• Current evidence of an uncontrolled and/or clinically significant medical condition
• History of seizures or epilepsy
• 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
• Recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
• Presence of devices (e.g., pacemakers, cochlear prosthesis, neurostimulators)
• Abnormal ear anatomy or ear infection present
• Women of childbearing potential not using adequate contraception as per investigator judgement or not willing to comply with contraception for the duration of the study
• Females who are pregnant or lactating
• 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

• Recovery Unplugged — Austin, Texas, United States

Full record on ClinicalTrials.gov

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