Re-Treatment Study of Probuphine in Opioid Addiction

Phase 3

Completed

• Conditions: Opioid Dependency
• Interventions: Drug: Probuphine (buprenorphine implant)

• Registration Number: NCT01262261
• Lead Sponsor: Titan Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-16
• Study First Posted: 2010-12-17
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Disposition First Submitted: 2012-10-24
• Disposition First Submitted QC: 2012-10-24
• Disposition First Posted: 2012-10-30
• Status Verified: 2017-06
• Last Update Submitted: 2018-12-27
• Last Update Posted: 2018-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Probuphine	Probuphine (buprenorphine implant)	patients are first inducted on sublingual buprenorphine then switched to 4 Probuphine Implants

Primary Outcome Measures

Name	Time	Method
Number of subjects with Adverse Events (AEs) as a measure of safety	29 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic analyses through plasma buprenorphine concentration in subjects 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
Patient-rated opioid use and problems Responder Analysis as a measure of efficacy	24 weeks
Percent of subjects retained as a measure of efficacy	24 weeks
Mean subjective opioid cravings scores as a measure of efficacy	24 weeks
Percent of subjects reporting illicit drug use 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
Mean total score on Beck Depression Inventory (BDI-II) as a measure of efficacy	24 weeks

Trial Locations

Locations (18)

Amit Vijapura, MD; 🇺🇸 Jacksonville, Florida, United States

Fidelity Clinical Research; 🇺🇸 Lauderhill, Florida, United States

Operation PAR, Inc. - TC Campus; 🇺🇸 Largo, Florida, United States

University of Vermont; 🇺🇸 Burlington, Vermont, United States

Stanley Street Treatment and Resources, Inc; 🇺🇸 Fall River, Massachusetts, United States

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

Friends Research Institute; 🇺🇸 Torrance, California, United States

BPRU, Behavioral Biology Research Center; 🇺🇸 Baltimore, Maryland, United States

North County Clinical Research; 🇺🇸 Oceanside, California, United States

David Geffen School of Medicine at UCLA; 🇺🇸 Los Angeles, California, United States

Synergy Clinical Research Center; 🇺🇸 National City, California, United States

Scientific Clinical Research, Inc.; 🇺🇸 North Miami, Florida, United States

Precise Research Centers; 🇺🇸 Flowood, Mississippi, United States

Psych Care Consultants Research; 🇺🇸 Saint Louis, Missouri, United States

St. Luke's Roosevelt Hospital Center; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Carolina Clinical Trials, Inc.; 🇺🇸 Charleston, South Carolina, United States

Providence Behavioral Health Services; 🇺🇸 Everett, Washington, United States