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

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with depot naltrexone during Phase II.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spark Biomedical, Inc.
• Treatments: Lofexidine; Naltrexone

Criteria

Inclusion Criteria:

1. Participant shows signs of current opioid dependence; prescriptive or non-prescriptive

2. Participant COWS score is ≥ 8 or in the opinion of the investigator the participant is in moderate to severe withdrawal at the baseline assessment

3. Participant is between 18 and 65 years of age

4. Participant is English Proficient

5. Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements

Exclusion Criteria:

1. Participant presents current evidence of an uncontrolled and/or clinically significant medical condition

2. Participant has a history of seizures or epilepsy

3. Participant has a history of neurological diseases or traumatic brain injury

4. Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment

5. Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation

6. Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators

7. Participant has abnormal ear anatomy or ear infection present

8. Participant is unwilling to transition to opioid antagonist medication following acute detox treatment

9. Participant has unstable psychiatric illness based on the Mini International Neuropsychiatric Interview (MINI)

10. 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

11. Females who are pregnant or lactating

12. 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