Probuphine Innovations for Clinical Effectiveness (PRINCE)

NCT02896660 | Unknown

• 1 other identifier: Pro00018757
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Opioid Dependence

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (2)

• Number of participants with changes in sleep quality, as assessed by ActiGraph Link GT9X-BT

  90 days

• Number of participants with changes in quality of life, as assessed by WHOQOL-BREF

  90 days

Other Outcomes (2)

• Number of participants with changes in self-reported desire/need to use symptoms, as assessed by Assessment of Withdrawal from Opioids Scale (SOWS)

  90 days

• Number of participants with changes in clinician-reported desire/need to use symptoms, as assessed by Clinical Opiate Withdrawal Scale (COWS)

  90 days

Study Arms (1)

ActiGraph Link

EXPERIMENTAL

Study participants will wear an actigraphy device, the ActiGraph Link, continuously for 90 days

Device: ActiGraph Link

Interventions

ActiGraph Link DEVICE

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.

ActiGraph Link

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Healthcare Innovation Technology Lab: lead
• Braeburn Pharmaceuticals: collaborator

Related Publications (4)

• 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.

  PMID: 24999989 BACKGROUND

• 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.

  PMID: 9539676 BACKGROUND

• 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.

  PMID: 12749557 BACKGROUND

• 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.

  PMID: 14655927 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Stan Kachnowski, PhD

  Healthcare Innovation Technology Lab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Chokshi, PhD

CONTACT

212-543-0100; schokshi@hitlab.org

Kathleen A Lynch, MS

CONTACT

212-543-0100; klynch@hitlab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 12, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: September 12, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share