Remote Observed Dosing to Increase Suboxone Compliance

Not Applicable

Completed

• Conditions: Opiate Dependence
• Interventions: Behavioral: Remote Observed Dosing

• Registration Number: NCT01779973
• Lead Sponsor: University of Pennsylvania

Brief Summary

The goal of this project is to test the feasibility, acceptability, and preliminary efficacy of using remote compliance monitoring in buprenorphine (Suboxone®) treatment for opiate dependence. To that end, 10 opiate dependent subjects will be recruited through the University of Pennsylvania's Treatment Research Center, an outpatient substance abuse treatment facility. All subjects will receive buprenorphine (Suboxone®) (16 mg/day, adjusted as needed according to individual requirements).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-30
• Study Start: 2013-02
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-11-03
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Voluntarily provide written informed consent prior to the conduct of any study-related procedure
• Male or female, 18 to 65 years of age,
• Meet DSM-IV criteria for current opioid dependence
• Females of childbearing potential and fertile males must use a reliable means of contraception
• Owns a smartphone with forward facing camera that allows for use of Skype

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Exclusion Criteria

• University of Pennsylvania student, employee, or affiliate
• Current diagnosis of AIDS
• Presence of AST and/or ALT equal to or 3X upper limit of normal
• Total bilirubin and/or creatinine equal to or 1.5X upper limit or normal
• Current diagnosis of chronic pain requiring opioids
• Pregnant or lactating females
• Previous hypersensitivity or allergy to buprenorphine or EVA-containing substances
• 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-IV criteria for current dependence on any psychoactive substances other than opioids or nicotine (e.g. alcohol, sedatives)
• Current use of benzodiazepines other than physician prescribed
• 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
• Participated in a clinical study within the previous 8 weeks

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remote Observed Dosing	Remote Observed Dosing	Compliance with dosage observations of suboxone doses using remote observed dosing 4 days per week and 1 weekly in-office visit.

Primary Outcome Measures

Name	Time	Method
The number of suboxone dose taken during the course of the study. The number of opiate-negative urine samples provided during the study.	9 months

Secondary Outcome Measures

Name	Time	Method
Patterns of missed doses including visit times and frequency impact.	9 months

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States