Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use … (NCT05053503) | Clinical Trial Compass
CompletedNot Applicable
Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
United States108 participantsStarted 2022-05-27
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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