Ear stimulation may ease depression in addiction treatment

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Able and willing to provide informed consent. * 18 to 60 years of age. * History of substance use disorder involving illicit substances, such as opioids, stimulants, or sedatives. * Currently enrolled in treatment for substance use disorder or actively seeking treatment. * Score of 11 or greater on the Patient Health Questionnaire-9 (PHQ-9), indicating at least moderate depression symptoms. * If taking medication for depression, anxiety, or sleep, on a stable dose for at least 2 weeks before the baseline visit, when feasible. * Able to read, speak, and understand English well enough to complete study procedures and questionnaires.16 17• Willing and able to comply with study visits and study procedures for approximately 30 days. Exclusion Criteria: * Currently participating in another research study that includes an active treatment or intervention. * Diagnosis of a neurological disorder, such as Parkinson's disease. * Permanent implanted metal or electronic device near the ear, including certain hearing, heart, or nerve stimulation devices. * Previous surgery involving the vagus nerve. * Resting heart rate less than 50 beats per minute. * Severe coronary artery disease or heart attack within the past 5 years. * Active infection, skin condition, or skin breakdown on or near the outer ear where the device would be placed. * History of trigeminal neuralgia within the past year. * Pregnant, planning to become pregnant during the study, or suspected to be pregnant. * Current severe or unstable psychiatric condition that would interfere with participation, such as active psychosis or acute suicidal risk. * Acute intoxication or severe withdrawal symptoms at screening or baseline that would interfere with study participation. * Significant abnormalities of the outer ear that would interfere with placement or use of the study device. * Current use of another neuromodulation therapy, such as transcranial magnetic stimulation (TMS) or vagus nerve stimulation. * Court-mandated addiction treatment. * Incarcerated individuals. * Unable to provide informed consent or comply with study procedures. * Any medical, psychiatric, or social condition that, in the opinion of the investigator, would make participation unsafe or interfere with study results.