drugset / Trial / NCT05053503
Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
Completed
108 enrolled
Spark Biomedical, Inc.
Gaudenzia, Inc. · collabHazelden Betty Ford Foundation · collab
RandomizedFactorialQuadruple-blindPrevention
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.
Timeline
- Start
- 2022-05-27
- Primary completion
- 2025-04-04
- Completion
- 2025-04-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lofexidine | Small molecule | 0.54 mg | — |
| Subject | Naltrexone | Small molecule | — | — |