Activity Monitors for Opioid Dependence Treated With Probuphine

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).