Remote Observed Dosing of Suboxone to Improve Clinical Practice

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03769025
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 39
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid-use Disorder; Opioid Dependence; Opiate Dependence	Behavioral: Suboxone Remote Observed Dosing; Other: Suboxone Attention Control	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Remote Observed Dosing of Suboxone to Improve Clinical Practice
• Actual Study Start Date: Apr 1, 2019
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	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
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	Other: Suboxone Attention Control; Attention control group will send a text message daily confirming that they have taken their Suboxone dose

Outcome Measures

Primary Outcome Measures

1. Mean Urinary Buprenorphine Levels [12 weeks]

   compare the mean urinary buprenorphine level obtained over 12 weeks between the two groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania Treatment Research Center	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Study Director: Kyle Kampman, MD, University of Pennsylvania
• Principal Investigator: Brenda Curtis, PhD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kyle Kampman, Medical Director, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03769025
• Other Study ID Numbers: RODS
• First Posted: Dec 7, 2018
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Kyle Kampman, Medical Director, University of Pennsylvania: remote observed dosing
• Additional relevant MeSH terms: Opioid-Related Disorders; Buprenorphine, Naloxone Drug Combination

Study Results

No Results Posted as of Apr 1, 2022