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BRIDGE Device for Treatment of Opioid Withdrawal

NCT04162145 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-06-25

No results posted yet for this study

Summary

The purpose of this study is to prospectively evaluate the effectiveness of the NSS-2 BRIDGE device in reducing the signs and symptoms of acute opioid withdrawal when compared to placebo.

Conditions

  • Opioid Withdrawal
  • Pain
  • Craving

Interventions

DEVICE

Active BRIDGE device placement

The active BRIDGE device will be placed by a blinded medical provider. The severity of opioid withdrawal signs and symptoms will be assessed with the COWS, pain and cognitive functioning tests at several time points. Patients will be dosed with buprenorphine at the blinded provider's discretion. Supportive medications to help manage signs and symptoms of opioid withdrawal will NOT be allowed for one hour after the first dose of buprenorphine. Subjects will be asked to return to clinic for additional visits based on the clinic standard of care. Subjects will be reassessed using COWS, OCS and VAS at each subsequent visit, or remotely (via phone) when unrequired to return to clinic during the 5-day trial. The device will be removed at the clinic visit on Day 5 and disposed of in a sharps container. If the patient cannot come back on day 5, they will be instructed to remove the device at home and bring it back at the next clinic appointment for proper disposal.

DEVICE

Inactive BRIDGE device placement

The inactive or sham BRIDGE device will be placed by a blinded medical provider. The severity of opioid withdrawal signs and symptoms will be assessed with the COWS, pain and cognitive functioning tests at several time points. Patients will be dosed with buprenorphine at the blinded provider's discretion. Supportive medications to help manage signs and symptoms of opioid withdrawal will NOT be allowed for one hour after the first dose of buprenorphine. Subjects will be asked to return to clinic for additional visits based on the clinic standard of care. Subjects will be reassessed using COWS, OCS and VAS at each subsequent visit, or remotely (via phone) when unrequired to return to clinic during the 5-day trial. The device will be removed at the clinic visit on Day 5 and disposed of in a sharps container. If the patient cannot come back on day 5, they will be instructed to remove the device at home and bring it back at the next clinic appointment for proper disposal.

Sponsors & Collaborators

  • Innovative Health Solutions

    collaborator INDUSTRY

  • BrightView LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2020-06-23
Completion
2020-06-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04162145 on ClinicalTrials.gov