Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

BRIDGE Device for Treatment of Opioid Withdrawal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04162145
Recruitment Status : Terminated (Due to COVID-19 pandemic)
First Posted : November 14, 2019
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
Innovative Health Solutions
Information provided by (Responsible Party):
BrightView LLC

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.

Condition or disease Intervention/treatment Phase
Opioid Withdrawal Pain Craving Device: Active BRIDGE device placement Device: Inactive BRIDGE device placement Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups will be studied: one group using active BRIDGE devices and one using sham or inactive devices.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: BRIDGE Device for Symptoms of Opioid Withdrawal: A Randomized, Double-Blind, Placebo-Controlled Study
Actual Study Start Date : November 15, 2019
Actual Primary Completion Date : June 23, 2020
Actual Study Completion Date : June 23, 2020

Arm Intervention/treatment
Active Comparator: Active Device
Patients in the Active Device arm will receive placement of an active BRIDGE device.
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.

Sham Comparator: Sham Device
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
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.




Primary Outcome Measures :
  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 [ Time Frame: 3 months ]

    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.



Secondary Outcome Measures :
  1. 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 [ Time Frame: 3 months ]

    As a secondary analysis the investigators will examine the change over time of the Clinical Opiate Withdrawal Scale (COWS) scores between groups using a mixed-effects model repeated measures (MMRM) analysis incorporating treatment period data up to 3 months.

    The effects in the model will include the baseline score, treatment groups, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit week will be treated as the repeated variable within a patient. Patient, treatment, and visit will be treated as class variables. Unstructured covariance matrix will be used initially, and additional types (e.g., auto- regression, Toeplitz, CS, etc.) will be tried to assess the robustness of the unstructured matrix. Comparison between treatments will be based on contrasts of least square treatment means at each week of interest. Least square means, standard errors, and 95% confidence intervals (CI) of treatment difference will be reported for the two groups.


  2. 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 [ Time Frame: 3 months ]
    As a secondary analysis the investigators will examine the change over time of the pain Visual Analog Scale (VAS) scores (0= not at ll, 10=extremely) between groups using a mixed-effects model repeated measures (MMRM) analysis incorporating treatment period data up to 3 months.

  3. 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 [ Time Frame: 3 months ]

    As a secondary analysis the investigators will examine the change over time of the Opioid Craving Scale (OCS) scores (0= not at all, 10=extremely) between groups using a mixed-effects model repeated measures (MMRM) analysis incorporating treatment period data up to 3 months.

    The effects in the model will include the baseline score, treatment groups, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit week will be treated as the repeated variable within a patient. Patient, treatment, and visit will be treated as class variables. Unstructured covariance matrix will be used initially, and additional types (e.g., auto- regression, Toeplitz, CS, etc.) will be tried to assess the robustness of the unstructured matrix. Comparison between treatments will be based on contrasts of least square treatment means at each week of interest. Least square means, standard errors, and 95% confidence intervals (CI) of treatment difference will be reported for the two groups.


  4. 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 [ Time Frame: 3 months ]
    As a secondary analysis the investigators will examine the change over time of cognitive function measured by the Stroop test (CNS Vital Signs) between groups using a mixed-effects model repeated measures (MMRM) analysis incorporating treatment period data up to 3 months. The test has three parts. In the first, the words RED, YELLOW, BLUE and GREEN (printed in black) appear at random on the screen, and the subject presses the space bar as soon as he or she sees the word. This generates a simple reaction time score.The subject is asked to press the space bar when the color of the word matches what the word says. This generates a complex reaction time score. In the third part, the subject is asked to press the space bar when the color of the word does not match what the word says. This part also generates a complex reaction time score, called the "Stroop reaction time.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04162145


Locations
Layout table for location information
United States, Ohio
Brightview LLC
Cincinnati, Ohio, United States, 45206
BrightView
Cincinnati, Ohio, United States, 45206
Sponsors and Collaborators
BrightView LLC
Innovative Health Solutions
  Study Documents (Full-Text)

Documents provided by BrightView LLC:
Informed Consent Form  [PDF] September 24, 2019

Layout table for additonal information
Responsible Party: BrightView LLC
ClinicalTrials.gov Identifier: NCT04162145    
Other Study ID Numbers: 7454-JACraven
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by BrightView LLC:
opioid withdrawal
opioid
pain
craving
NSS-2 BRIDGE
percutaneous electrical nerve field stimulator (PENFS)
Additional relevant MeSH terms:
Layout table for MeSH terms
Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders