Remote Observed Dosing to Increase Suboxone Compliance

Study Overview
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Brief Summary
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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).

Conditions
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Opiate Dependence

Intervention / Treatment
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* Behavioral: Remote Observed Dosing


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Observed Dosing<br>Compliance with dosage observations of suboxone doses using remote observed dosing 4 days per week and 1 weekly in-office visit. | Behavioral: Remote Observed Dosing<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patterns of missed doses including visit times and frequency impact. |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skype, compliance, remote dosing, suboxone, opiate, opiates, heroin, oxycontin, Philadelphia