An interventional study of The Bridge in Substance Use Disorders, Substance Abuse and Substance Use, sponsored by The Cleveland Clinic. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-09-23.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
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.
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
Browse Substance-Related Disorders studies →The Cleveland Clinic is the lead sponsor of 819 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
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Exclusion Criteria:
All participants will receive the Bridge device.
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.
Primary Objective
Number of patients who complete three follow-up visits while taking naltrexone and produce entirely negative urine opiate screens during that period
Time frame: Three Months
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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