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
About this trial
This is an interventional basic science trial for Opioid Dependence
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
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
NCT ID
NCT02896660
First Posted
August 29, 2016
Last Updated
September 6, 2016
Sponsor
Healthcare Innovation Technology Lab
Collaborators
Braeburn Pharmaceuticals
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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