Can The Bridge Transition Opiate Use Disorder Patients in... | NCT03762798

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

NCT03762798

Sponsor

The Cleveland Clinic

Status

Withdrawn

Last Update Posted

Sep 23, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Substance Use Disorders
Substance Abuse
Substance Use
Substance Dependence

Interventions

The Bridge

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not able to enroll participants.

Expanded Access Info

Start Date

Nov 19, 2018Actual

Primary Completion Date

Oct 25, 2020Actual

Completion Date

Dec 1, 2020Actual

First Submitted Date

Nov 28, 2018

First Submission Date that Met QC Criteria

Dec 3, 2018

First Posted Date

Dec 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2021

Last Update Posted Date

Sep 23, 2021Actual

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	All participants will receive the Bridge device.	Device: The Bridge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The Bridge	Device	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.

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders