BRIDGE Device for Treatment of Opioid Withdrawal

NCT04162145 | Terminated FDA Device

• 1 other identifier: 7454-JACraven
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

opioid withdrawal; opioid; pain; craving; NSS-2 BRIDGE; percutaneous electrical nerve field stimulator (PENFS)

Outcome Measures

Primary Outcomes (1)

• Comparison of change from baseline of Clinical Opiate Withdrawal Scale (COWS) scores between active BRIDGE device group and sham BRIDGE device group at one hour

  The primary outcome is comparison of change from baseline of the Clinical Opiate Withdrawal Scale (COWS) scores( score: 5-12=Mild; 13-24=Moderate; 25-36=Moderately Severe; More than 36=Severe Withdrawal) between active BRIDGE device group and sham BRIDGE device group at one hour. The two groups will be compared using a two-sided two sample t-test at an alpha of 0.001 at an interim analysis of the first 24 completing and at an alpha of 0.049 after 50 have completed. For all the efficacy parameters (e.g. Clinical Opiate Withdrawal Scale, Visual Analog Scale, Opioid Craving Scale and the Stroop test using CNS Vital Signs) the descriptive statistics will include N, mean median, standard error (SE), minimum and maximum or percentage and exact Clopper Pearson 95% confidence interval.

  3 months

Secondary Outcomes (4)

• Comparison of change from baseline of Clinical Opiate Withdrawal Scale (COWS) scores between active BRIDGE device group and sham BRIDGE device group over time for up to 3 months

  3 months

• Comparison of change from baseline of pain Visual Analog Scale (VAS) scores between active BRIDGE device group and sham BRIDGE device group over time for up to 3 months

  3 months

• Comparison of change from baseline of Opioid Craving Scale (OCS) scores between active BRIDGE device group and sham BRIDGE device group over time for up to 3 months

  3 months

• Comparison of change from baseline of cognition Stroop test scores using CNS Vital Signs software between active BRIDGE device group and sham BRIDGE device group over time for up to 3 months

  3 months

Study Arms (2)

Active Device

ACTIVE COMPARATOR

Patients in the Active Device arm will receive placement of an active BRIDGE device.

Device: Active BRIDGE device placement

Sham Device

SHAM COMPARATOR

Patients in the Sham Device arm will receive placement of an inactive, or sham, BRIDGE device. The inactive device will be identical in appearance to the active device but will have no electrical current.

Device: Inactive BRIDGE device placement

Interventions

Active BRIDGE device placement DEVICE

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.

Active Device

Inactive BRIDGE device placement DEVICE

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.

Sham Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be 18 years or older who speak English and meet criteria for opioid use disorder based on the Diagnostic and Statistical Manual of Mental Disorders-5.

Sponsors & Collaborators

• BrightView LLC: lead
• Innovative Health Solutions: collaborator

Study Sites (2)

Brightview LLC

Cincinnati, Ohio, 45206, United States

Location

BrightView

Cincinnati, Ohio, 45206, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomly assigned to one of the 2 treatment groups in equal ratio. Randomization will be done centrally using a randomized block design, with blocks of 4 using the Pqantadosi Randomization software. There will be a randomization table provided to the person dispensing the devices. The unblinded, lead research coordinator will keep the data in a secure database and will not be involved in any of the patient recruitment or study procedures. All other research coordinators, investigators, and nurses involved will be blinded to group allocation. In general, the study biostatisticians and the person dispensing will be the only people un-blinded throughout the duration of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two groups will be studied: one group using active BRIDGE devices and one using sham or inactive devices.

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 14, 2019
• Study Start: November 15, 2019
• Primary Completion: June 23, 2020
• Study Completion: June 23, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06

Locations

US (2)