NCT03762798

Can The Bridge Transition Opiate Use Disorder Patients in Stable Recovery From Buprenorphine to Naltrexone

Can The Bridge Facilitate Successful Transition From Medication-Assisted Treatment (MAT) With Low-dose Sublingual Buprenorphine to Oral Naltrexone in Patients With Extended Remission of Opiate Use Disorder

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single center study of The Bridge in patients with sustained remission of opiate dependence on established, low-dose MAT with buprenorphine. A fixed number of patients will be admitted to the study.

Detailed description

This is an open-label, single center study of The Bridge in patients with sustained remission of opiate dependence on established, low-dose MAT with buprenorphine. A fixed number of patients will be admitted to the study. After determination that the subject meets the inclusion criteria and does not meet any of the exclusion criteria for the study, the subject will receive the device which will be applied in the clinical office setting on an outpatient basis. Buprenorphine MAT will be stopped immediately and the subject will be followed on an outpatient basis to ensure the process has been successful. The subject will have the option to return to the office for a follow-up assessment in 1-4 days after device application. Seven to ten days after the last dose of buprenorphine, a urine sample will be collected for drug testing and a prescription for naltrexone will be provided. Then three visits on a roughly monthly basis will be scheduled. At each visit a urine sample for drug testing will be collected. After three follow-up visits are completed, if the drug testing demonstrates continued sobriety, the subject will be released from the study and may or may not continue treatment with naltrexone.

Conditions

• Substance Use Disorders
• Substance Abuse
• Substance Use
• Substance Dependence

Interventions

Type	Name	Description
DEVICE	The Bridge	The Bridge (Also known as NSS-2) is a percutaneous, auricular field stimulator developed to alleviate pain through stimulation of peripheral cranial neurovascular bundles in the external ear that could potentially gain access to brain areas involved in fear, pain and nociception. After five days, the subject will return to the clinic for device removal and disposal.

Timeline

• Start date: 2018-11-19
• Primary completion: 2020-10-25
• Completion: 2020-12-01
• First posted: 2018-12-04
• Last updated: 2021-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study