Study of Probuphine in Patients With Opioid Dependence

NCT00772785 | Terminated Phase 3 DMC

• 1 other identifier: PRO-809
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Dependency

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  24 WEEKS

Secondary Outcomes (1)

• Plasma buprenorphine concentration

  24 WEEKS

Study Arms (1)

Probuphine

EXPERIMENTAL

buprenorphine implant

Drug: Probuphine (buprenorphine implant)

Interventions

Probuphine (buprenorphine implant) DRUG

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

Probuphine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Titan Pharmaceuticals: lead

Study Sites (1)

Scientific Clinical Research, Inc.

North Miami, Florida, 33161, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 15, 2008
• Study Start: September 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 31, 2018

Record last verified: 2017-06

Locations

US (1)