Pain Clinical Trial
Official title:
BRIDGE Device for Symptoms of Opioid Withdrawal: A Randomized, Double-Blind, Placebo-Controlled Study
Verified date | June 2020 |
Source | BrightView LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 12 |
Est. completion date | June 23, 2020 |
Est. primary completion date | June 23, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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: - |
Country | Name | City | State |
---|---|---|---|
United States | BrightView | Cincinnati | Ohio |
United States | Brightview LLC | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
BrightView LLC | Innovative Health Solutions |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 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. |
3 months | |
Secondary | 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 | 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 months | |
Secondary | 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 | 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. |
3 months | |
Secondary | 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 | 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. | 3 months |
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