Can The Bridge Transition Opiate Use Disorder Patients in Stable Recovery From Buprenorphine to Naltrexone
NCT03762798 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2021-09-23
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.
Conditions
- Substance Use Disorders
- Substance Abuse
- Substance Use
- Substance Dependence
Interventions
- 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.
Sponsors & Collaborators
-
The Cleveland Clinic
lead OTHER
Principal Investigators
-
David W Streem, MD · The Cleveland Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-19
- Primary Completion
- 2020-10-25
- Completion
- 2020-12-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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