Remote Observed Dosing of Suboxone to Improve Clinical Practice

Overview

This is a 15-week, outpatient study of remote observed dosing to improve suboxone compliance in opiate dependent subjects.The main purpose of this study is to see if watching patients take their medication will improve treatment of opiate dependence by prompting patients to take all prescribed doses of Suboxone. Suboxone is approved by the Food and Drug Administration (FDA) for the treatment of opiate dependence. All patients receive a smartphone and patients in the intervention (remote observed dosing) group will use the smartphone to take videos of themselves taking Suboxone.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: May 31, 2022

Interventions

• Behavioral: Suboxone Remote Observed Dosing
  • The remote observed dosing group will use the provided smartphone to video record themselves taking their Suboxone dose each day
• Other: Suboxone Attention Control
  • Attention control group will send a text message daily confirming that they have taken their Suboxone dose

Arms, Groups and Cohorts

• Experimental: Remote Observed Dosing
  • One group will be assigned to Remote Observed Dosing (ROD) and will have all of their Suboxone® doses remotely observed. The intervention is remote observed dosing
• Active Comparator: Attention Control
  • The attention control (AC) group will not have their dosing observed but will send a text message confirming they have taken their study medication to the study team daily matching contact with the study team. Text message confirming that they have taken their study medication is the intervention

Clinical Trial Outcome Measures

Primary Measures

• Mean Urinary Buprenorphine Levels
  • Time Frame: 12 weeks
  • compare the mean urinary buprenorphine level obtained over 12 weeks between the two groups

Participating in This Clinical Trial

Inclusion Criteria

• Voluntarily provide written informed consent prior to the conduct of any study-related procedure – Male, female, or transgender – 18 – 45 years of age – Meet DSM 5 criteria for opioid use disorder moderate to severe – Women of childbearing potential must use a reliable means of contraception Exclusion Criteria:

• Current diagnosis of AIDS – Participation in buprenorphine maintenance treatment within the past 3 months – Presence of AST and/or ALT equal to or > 3X upper limit of normal – Total bilirubin equal to or > 1.5X upper limit of normal and/or estimated creatinine clearance < 60ml/min – Current diagnosis of pain requiring opioids – Pregnant or lactating women – Previous hypersensitivity or allergy to buprenorphine – Current use of agents metabolized through CYP 3A4 such as azole antifungals (e.g. ketoconazole), macrolide antibiotics (e.g. erythromycin), and protease inhibitors (e.g. ritonavir, indinavir, saquinavir) – Meet DSM – 5 criteria for current use disorder for any psychoactive substances other than opioids, marijuana, cocaine or nicotine (e.g. alcohol, sedatives) – Current use of benzodiazepines – Significant medical or psychiatric symptoms or dementia which in the opinion of the investigators would preclude compliance with the protocol, adequate cooperation in the study, or obtaining informed consent – Concurrent medical conditions (such as severe respiratory insufficiency) that may prevent the patient from safely participating in the study; and/or any pending legal action that could prohibit participation and/or compliance in study procedures – Unwilling to accept or use alternative transportation (i.e. public transportation, taxi services, etc.) instead of driving self to appointments during Suboxone Induction – Living in unstable housing

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University of Pennsylvania
• Provider of Information About this Clinical Study
  • Principal Investigator: Kyle Kampman, Medical Director – University of Pennsylvania
• Overall Official(s)
  • Kyle Kampman, MD, Study Director, University of Pennsylvania
  • Brenda Curtis, PhD, Principal Investigator, University of Pennsylvania