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Probuphine Innovations for Clinical Effectiveness (PRINCE) (PRINCE)

Primary Purpose

Opioid Dependence

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ActiGraph Link
Sponsored by
Healthcare Innovation Technology Lab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Opioid Dependence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Eligible subjects must:

  1. Be Adults over the age of 18
  2. Speak English
  3. In treatment for opioid addiction/dependence
  4. Meet the criteria for treatment with Probuphine (on 8mg or less Subutex or Suboxone sublingual tablet or generic equivalent not requiring dose adjustment x 1 month)
  5. Be clinically stable
  6. Be willing to follow study procedures-including wearing a wearable actigraphy device-for 3 months

Exclusion Criteria:

Potential subjects must not:

  1. Be less than 18 years of age
  2. Do not meet the criteria for opioid dependence based on APA guidelines
  3. Do not meet the criteria for treatment with Probuphine
  4. Are not clinically stable or suffer from other mitigating issues surrounding addiction or psychological state.
  5. Are not willing to follow study procedures-including wearing a wearable actigraphy device-for 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ActiGraph Link

    Arm Description

    Study participants will wear an actigraphy device, the ActiGraph Link, continuously for 90 days

    Outcomes

    Primary Outcome Measures

    Number of participants with changes in energy levels, as assessed by ActiGraph Link GT9X-BT
    Patients will wear an actigraphy device to assess changes in activity over a 90-day period.

    Secondary Outcome Measures

    Number of participants with changes in sleep quality, as assessed by ActiGraph Link GT9X-BT
    Patients will wear an actigraphy device to assess changes in sleep quality over a 90-day period.
    Number of participants with changes in quality of life, as assessed by WHOQOL-BREF

    Full Information

    First Posted
    August 29, 2016
    Last Updated
    September 6, 2016
    Sponsor
    Healthcare Innovation Technology Lab
    Collaborators
    Braeburn Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02896660
    Brief Title
    Probuphine Innovations for Clinical Effectiveness (PRINCE)
    Acronym
    PRINCE
    Official Title
    Activity Monitors for Opioid Dependence Treated With Probuphine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    April 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Healthcare Innovation Technology Lab
    Collaborators
    Braeburn Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    HITLAB will conduct a crossover study wherein participants will be asked to wear an actigraphy device continuously for 12 weeks. The first four weeks of the study participants will continue their previously scheduled treatment regimen, prior to receiving the Probuphine implant. Following four weeks of activity and sleep baseline monitoring using the actigraphy device, the participant will receive the Probuphine implant as part of their regularly scheduled treatment plan. Observation of the participant's activity levels will continue for eight weeks following implantation of Probuphine. Actigraphy measurements will include total time asleep, total time awake, sleep efficiency, and time mobile.
    Detailed Description
    HITLAB will conduct a crossover study that measures the activity levels and sleep quality of patients both before and during treatment with Probuphine in order to determine whether Probuphine offers the additional benefit of improved energy levels during treatment, further distinguishing it from other opioid dependency treatments. HITLAB researchers will meet with participating site physicians prior to study recruitment in order to administer the "Physician Baseline Questionnaire," a brief semi-structured baseline questionnaire to assess initial physician expectations for the actigraphy device. Per physician guidelines, patients must be in stable treatment for at least 1 month prior to study enrollment. If the physician determines Probuphine to be an appropriate treatment method for the study subject, the physician will meet with the subject and explain the purpose of the actigraphy. Upon enrollment, the physician will administer the "Participant Baseline Questionnaire," assessing general well-being, physical activity level, sleep patterns, and technology usage. At this time, the participant will be asked to begin wearing the Actigraph continuously for 12 weeks. The first four weeks of the study patients will continue their previously scheduled treatment regimen, prior to receiving the Probuphine implant. Following four weeks of activity and sleep baseline monitoring using the actigraph device, the participant will receive the Probuphine implant [day 30]. At this visit, the clinician will administer four clinical assessments: Assessment of Withdrawal from Opioids Scale (SOWS), Clinical Opiate Withdraw Scale (COWS), Visual Analog Scales (VAS), and Measures of Morning Desire to use/need to use tool from Braeburn Pharmaceuticals (HS-11-421), as well as a baseline quality of life assessment (WHOQOL-BREF). Observation of the participant's activity levels will continue for a total of eight weeks following implantation of Probuphine. Actigraphy measurements will include total time asleep, total time awake, sleep efficiency, and time mobile. At the midline 60-day visit with each participant, as part of their regular monthly treatment appointment, the physician will repeat administration of the four clinical assessments (The Assessment of Withdrawal from Opioids Scale (SOWS), Clinical Opiate Withdraw Scale (COWS), Visual Analog Scales (VAS), and Measures of Morning Desire to use/Need to use tool from Braeburn Pharmaceuticals (HS-11-421)), as well as the quality of life assessment (WHOQOL-BREF). At the participant endline visit [90 days], a physician will administer a repeat quality of life questionnaire (WHOQOL-BREF), and the four clinical assessments: Assessment of Withdrawal from Opioids Scale (SOWS), Clinical Opiate Withdraw Scale (COWS), Visual Analog Scales (VAS), and Measures of Morning Desire to use/need to use tool from Braeburn Pharmaceuticals (HS-11-421). In addition, five participants will be randomly selected to participate in a short qualitative interview at the time of the site endline visit. Participant interviews, in person or via telephone, will assess their experience using the actigraph device during treatment, and their perspectives on activity changes and sleep quality. Patient perspectives on activity changes and sleep quality will serve as a point of triangulation for the actigraphy data. HITLAB will conduct a baseline site visit, a site visit after 30 days, after 60 days, and after 90 days (the endline visit) of the study period to collect questionnaire and assessment data for analysis. Actigraphy data will be uploaded at days 30, 60 and 90. At the endline site visit, participating physicians will be asked to complete a brief, semi-structured "Physician Endline Questionnaire" to assess satisfaction with the actigraphy device in helping them improve outcomes and quality of life for patients in Probuphine treatment. A HITLAB researcher will also conduct a brief qualitative interview with the physicians at the endline site visit. The in-person physician interviews will assess whether the actigraphy data informed patient experience in such a way that it improves the efficacy of Probuphine administration and treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Opioid Dependence

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ActiGraph Link
    Arm Type
    Experimental
    Arm Description
    Study participants will wear an actigraphy device, the ActiGraph Link, continuously for 90 days
    Intervention Type
    Device
    Intervention Name(s)
    ActiGraph Link
    Intervention Description
    Subjects will be asked to wear the actigraph continuously for a 90-day period, and visit a clinician on day 30, 60, and 90 of the study for data collection.
    Primary Outcome Measure Information:
    Title
    Number of participants with changes in energy levels, as assessed by ActiGraph Link GT9X-BT
    Description
    Patients will wear an actigraphy device to assess changes in activity over a 90-day period.
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    Number of participants with changes in sleep quality, as assessed by ActiGraph Link GT9X-BT
    Description
    Patients will wear an actigraphy device to assess changes in sleep quality over a 90-day period.
    Time Frame
    90 days
    Title
    Number of participants with changes in quality of life, as assessed by WHOQOL-BREF
    Time Frame
    90 days
    Other Pre-specified Outcome Measures:
    Title
    Number of participants with changes in self-reported desire/need to use symptoms, as assessed by Assessment of Withdrawal from Opioids Scale (SOWS)
    Time Frame
    90 days
    Title
    Number of participants with changes in clinician-reported desire/need to use symptoms, as assessed by Clinical Opiate Withdrawal Scale (COWS)
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Eligible subjects must: Be Adults over the age of 18 Speak English In treatment for opioid addiction/dependence Meet the criteria for treatment with Probuphine (on 8mg or less Subutex or Suboxone sublingual tablet or generic equivalent not requiring dose adjustment x 1 month) Be clinically stable Be willing to follow study procedures-including wearing a wearable actigraphy device-for 3 months Exclusion Criteria: Potential subjects must not: Be less than 18 years of age Do not meet the criteria for opioid dependence based on APA guidelines Do not meet the criteria for treatment with Probuphine Are not clinically stable or suffer from other mitigating issues surrounding addiction or psychological state. Are not willing to follow study procedures-including wearing a wearable actigraphy device-for 3 months
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sara Chokshi, PhD
    Phone
    212-543-0100
    Ext
    30
    Email
    schokshi@hitlab.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kathleen A Lynch, MS
    Phone
    212-543-0100
    Ext
    16
    Email
    klynch@hitlab.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stan Kachnowski, PhD
    Organizational Affiliation
    Healthcare Innovation Technology Lab
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    All participant data will be anonymous and reported in aggregate.
    Citations:
    PubMed Identifier
    24999989
    Citation
    Hartwell EE, Pfeifer JG, McCauley JL, Moran-Santa Maria M, Back SE. Sleep disturbances and pain among individuals with prescription opioid dependence. Addict Behav. 2014 Oct;39(10):1537-42. doi: 10.1016/j.addbeh.2014.05.025. Epub 2014 Jun 2.
    Results Reference
    background
    PubMed Identifier
    9539676
    Citation
    Wilson KG, Watson ST, Currie SR. Daily diary and ambulatory activity monitoring of sleep in patients with insomnia associated with chronic musculoskeletal pain. Pain. 1998 Mar;75(1):75-84. doi: 10.1016/S0304-3959(97)00207-8.
    Results Reference
    background
    PubMed Identifier
    12749557
    Citation
    Ancoli-Israel S, Cole R, Alessi C, Chambers M, Moorcroft W, Pollak CP. The role of actigraphy in the study of sleep and circadian rhythms. Sleep. 2003 May 1;26(3):342-92. doi: 10.1093/sleep/26.3.342.
    Results Reference
    background
    PubMed Identifier
    14655927
    Citation
    Vallieres A, Morin CM. Actigraphy in the assessment of insomnia. Sleep. 2003 Nov 1;26(7):902-6. doi: 10.1093/sleep/26.7.902.
    Results Reference
    background

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    Probuphine Innovations for Clinical Effectiveness (PRINCE)

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