Clinical trial NCT02896660: Probuphine Innovations for Clinical Effectiveness (PRINCE)
Official title: Activity Monitors for Opioid Dependence Treated With Probuphine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Dependence
Lead sponsor: Healthcare Innovation Technology Lab
Sponsor class: INDUSTRY
Collaborators: name: Braeburn Pharmaceuticals
First posted: 2016-09-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with changes in energy levels, as assessed by ActiGraph Link GT9X-BT
timeFrame: 90 days
Secondary outcomes:
measure: Number of participants with changes in sleep quality, as assessed by ActiGraph Link GT9X-BT
timeFrame: 90 days
measure: Number of participants with changes in quality of life, as assessed by WHOQOL-BREF
timeFrame: 90 days
Other outcomes:
measure: Number of participants with changes in self-reported desire/need to use symptoms, as assessed by Assessment of Withdrawal from Opioids Scale (SOWS)
timeFrame: 90 days
measure: Number of participants with changes in clinician-reported desire/need to use symptoms, as assessed by Clinical Opiate Withdrawal Scale (COWS)
timeFrame: 90 days
Locations:
Study officials:
affiliation: Healthcare Innovation Technology Lab
name: Stan Kachnowski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.