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Probuphine Innovations for Clinical Effectiveness (PRINCE)

NCT02896660 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-09-12

No results posted yet for this study

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.

Conditions

  • Opioid Dependence

Interventions

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.

Sponsors & Collaborators

  • Braeburn Pharmaceuticals

    collaborator INDUSTRY

  • Healthcare Innovation Technology Lab

    lead INDUSTRY

Principal Investigators

  • Stan Kachnowski, PhD · Healthcare Innovation Technology Lab

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-03-31
Completion
2017-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02896660 on ClinicalTrials.gov