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Remote Observed Dosing of Suboxone to Improve Clinical Practice

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ClinicalTrials.gov Identifier: NCT03769025
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Kyle Kampman, University of Pennsylvania

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 : April 1, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Mean Urinary Buprenorphine Levels [ Time Frame: 12 weeks ]
    compare the mean urinary buprenorphine level obtained over 12 weeks between the two groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769025


Contacts
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Contact: Katherine Crockett 215-746-1990 kcrock@pennmedicine.upenn.edu
Contact: Kiara Benson 215-746-3621 bensonki@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Treatment Research Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Study Director: Kyle Kampman, MD University of Pennsylvania
Principal Investigator: Brenda Curtis, PhD University of Pennsylvania

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Responsible Party: Kyle Kampman, Medical Director, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03769025     History of Changes
Other Study ID Numbers: RODS
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University of Pennsylvania:
remote observed dosing

Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists