Status:
COMPLETED
Remote Observed Dosing of Suboxone to Improve Clinical Practice
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid-use Disorder
Opioid Dependence
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
PHASE2
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 medic...
Detailed Description
Opioid use disorder (OUD) is a significant public health problem. About 2 million Americans meet criteria for opioid use disorder involving prescription pain relievers and an additional 591,000 Americ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03769025
Start Date
April 1 2019
End Date
July 1 2022
Last Update
July 27 2023
Active Locations (1)
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1
University of Pennsylvania Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104