Re-Treatment Study of Probuphine in Opioid Addiction

Study Overview
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Brief Summary
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Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a 6-month, open-label, re-treatment study that will confirm the safety and efficacy of Probuphine in patients who have previously completed the 6-month PRO-806 study with either Probuphine, placebo or sublingual buprenorphine.

Official Title
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A Phase 3, Six-Month, Open-Label, Re-Treatment Study of Probuphine in Opioid Addiction

Conditions
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Opioid Dependency

Intervention / Treatment
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* Drug: Probuphine (buprenorphine implant)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has voluntarily provided written informed consent prior to conducting any study-related procedures Completion of 24 weeks of treatment in PRO-806 Subject has been deemed appropriate for entry into this extension study by the investigator Females of childbearing potential must be willing to use a reliable means of contraception during the entire study. Exclusion Criteria: An aspartate aminotransferase (AST) levels ≥ 3 X the upper limit of normal, alanine aminotransferase (ALT) levels ≥ 3 X the upper limit of normal, total bilirubin ≥ 1.5 X the upper limit of normal, or creatinine ≥ 1.5 X upper limit of normal on the screening laboratory assessments A current diagnosis of chronic pain requiring opioids for treatment A pregnant or lactating female Current use of agents metabolized through Cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir) A history of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin A significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigator would preclude compliance with the protocol, subject safety, adequate cooperation in the study, or obtaining informed consent Any current medical conditions such as severe respiratory insufficiency that may prevent the subject from safely participating in study, or any pending legal action that could prohibit participation or compliance in the study

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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probuphine<br>patients are first inducted on sublingual buprenorphine then switched to 4 Probuphine Implants | Drug: Probuphine (buprenorphine implant)<br>* Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with Adverse Events (AEs) as a measure of safety | AEs that occurred after the signing of the informed consent until 4 weeks after the implants have been removed were followed. Serious AEs and AEs that were designated as possibly related to study drug were followed until resolution or stabilization. | 29 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic analyses through plasma buprenorphine concentration in subjects as a measure of efficacy |  | 24 weeks | 
| Percent of subjects retained as a measure of efficacy |  | 24 weeks | 
| Percent of subjects reporting illicit drug use as a measure of efficacy |  | 24 weeks | 
| Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy |  | 24 weeks | 
| Mean total score on SOWS as a measure of efficacy |  | 24 weeks | 
| Mean total score on COWS as a measure of efficacy |  | 24 weeks | 
| Mean subjective opioid cravings scores as a measure of efficacy |  | 24 weeks | 
| Mean total score on Beck Depression Inventory (BDI-II) as a measure of efficacy |  | 24 weeks | 
| Patient-rated opioid use and problems Responder Analysis as a measure of efficacy |  | 24 weeks | 
| Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy |  | 24 weeks | 
| Overall satisfaction with treatment reported on Patient Satisfaction Survey |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid dependence, opioid addiction, buprenorphine, implant, methadone, heroin, suboxone, opioid pain medication, opioid withdrawal