Probuphine Innovations for Clinical Effectiveness (PRINCE) (PRINCE)

September 6, 2016 updated by: Healthcare Innovation Technology Lab

Activity Monitors for Opioid Dependence Treated With Probuphine

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ActiGraph Link
Study participants will wear an actigraphy device, the ActiGraph Link, continuously for 90 days
Device: ActiGraph Link
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
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
90 days
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
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healthcare Innovation Technology Lab

Collaborators

Braeburn Pharmaceuticals

Investigators

  • Principal Investigator: Stan Kachnowski, PhD, Healthcare Innovation Technology Lab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 12, 2016

Study Record Updates

Last Update Posted (Estimate)

September 12, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00018757

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All participant data will be anonymous and reported in aggregate.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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