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

Sponsor

The Cleveland Clinic (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03762798

Collaborator

(none)

Enrollment

Location

Arm

24.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Substance Use Disorders Substance Abuse Substance Use Substance Dependence	Device: The Bridge	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 19, 2018

Actual Primary Completion Date :

Oct 25, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment 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.

Arm

Intervention/Treatment

Experimental: Treatment

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.

Outcome Measures

Primary Outcome Measures

Primary Objective [Three Months]
Number of patients who complete three follow-up visits while taking naltrexone and produce entirely negative urine opiate screens during that period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of opiate use disorder, any severity
Age range 18-99 years old
Not pregnant or breastfeeding
Able to understand and provide informed consent.
Able to understand and speak the English language.
At least one year of abstinence from drugs of abuse including, but not limited to, all opiates, cannabis, benzodiazepines, barbiturates, alcohol and cocaine.
Use of nicotine is excluded from this criterion.
Use of any prescribed, controlled substance, taken according to the prescribing instructions, for no more than seven consecutive days, at least three months prior to the subject's study enrollment, is excluded from this criterion.
Taking dose of buprenorphine less than or equal to no more than 4 mg daily for at least three months prior to starting the study.
In the case of Zubsolv rapid-dissolve tablets, equivalent daily dose maximum would be 2.9mg.
In the case of Bunavail buccal film, equivalent daily dose maximum would be 2.1mg.
At least one year of self-reported, established 12-step based recovery work, including
Home group membership and regular attendance of two 12- step meetings per week
Regular work with 12-step sponsor who can attest that the subject has worked through step nine of the twelve steps of Alcoholics Anonymous or a similar 12-step based mutual help organization.

Exclusion Criteria:

Exhibits active psychosis or suicide ideation or is otherwise psychiatrically unstable.
Positive Utox2 Immunoassay, Quantitative Pain Panel Liquid Chromatography/Mass Spectroscopy, or Ethylglucuronide test for any nonprescribed substance or medication.
Meets criteria for any other active substance use disorder except nicotine
Allergic to naltrexone or has any condition of such nature and/or severity that would clinically contraindicate the prescribing of naltrexone.
Any condition that contraindicates the use of NSS-2 including hemophilia, cardiac pacemakers and psoriasis vulgaris.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Lutheran Hospital	Cleveland	Ohio	United States	44113

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Principal Investigator: David W Streem, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Streem, MD, Principal Investigator, The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT03762798

Other Study ID Numbers:

18-863

First Posted:

Dec 4, 2018

Last Update Posted:

Sep 23, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by David Streem, MD, Principal Investigator, The Cleveland Clinic

substance abuse

the bridge

Additional relevant MeSH terms:

Substance-Related Disorders

Study Results

No Results Posted as of Sep 23, 2021