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Study of Probuphine in Patients With Opioid Dependence

NCT ID: NCT00772785

Last Updated: 2018-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-02-28

Brief Summary

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Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine (buprenorphine implant) is an implant placed just beneath the skin that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study will test the safety and efficacy of Probuphine in the treatment of patients with opioid dependence. Patients who have completed at least 24 weeks of treatment in the Open-Label, Multi-Center Study of Probuphine in Patients with Opioid Dependence (PRO-807 Study), will be re-treated with Probuphine over an additional 24 weeks.

Detailed Description

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This is a 6-month, open-label, multi-center extension study. It is estimated that approximately 200 patients will be enrolled at approximately 25 sites in the United States (US). Following completion of either the PRO-807(NCT00630201) or PRO-808 studies, eligible patients will be implanted with Probuphine implants in the opposite arm for the PRO-809 study. Safety, BPN plasma levels, and efficacy measures will be collected during the 24-week treatment period.

Conditions

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Opioid Dependency

Keywords

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opioid dependence opioid addiction buprenorphine methadone heroin implant opioid withdrawal opioid pain medication suboxone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Probuphine

buprenorphine implant

Group Type EXPERIMENTAL

Probuphine (buprenorphine implant)

Intervention Type DRUG

Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants 6-month duration)

Interventions

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Probuphine (buprenorphine implant)

Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants 6-month duration)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must meet the following eligibility criteria:

* Expected to complete 24 weeks of treatment in PRO-807 or PRO-808
* Voluntarily provide written informed consent prior to the conduct of any study-related procedures
* Deemed appropriate for entry into this re-treatment study by the Investigator
* Females of childbearing potential and fertile males must use a reliable means of contraception

Exclusion Criteria

Patients are not eligible for enrollment if any of the following criteria are met:

* Presence of aspartate aminotransferase (AST) levels ≥ 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels ≥ 3 X upper limit of normal and/or total bilirubin ≥ 1.5 X upper limit of normal and/or creatinine ≥ 1.5 X upper limit of normal, measured at the time of the Week 20 Visit for the previous trial (PRO-807 or PRO-808), or any time less than 5 weeks prior to the Implant Visit.
* Current diagnosis of chronic pain requiring opioids for treatment
* Pregnant or lactating females
* Current use of agents metabolized through cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), and protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
* Current history of coagulopathy and anti-coagulant therapy (such as warfarin)
* Current use of benzodiazepines other than physician prescribed use
* Significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigator, would preclude compliance with the protocol, patient safety, 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 study; and/or any pending legal action that could prohibit participation and/or compliance in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Titan Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Scientific Clinical Research, Inc.

North Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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PRO-809

Identifier Type: -

Identifier Source: org_study_id