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Re-Treatment Study of Probuphine in Opioid Addiction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Titan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01262261
First received: December 15, 2010
Last updated: October 6, 2014
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Opioid Dependency
Drug: Probuphine (buprenorphine implant)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Six-Month, Open-Label, Re-Treatment Study of Probuphine in Opioid Addiction

Resource links provided by NLM:


Further study details as provided by Titan Pharmaceuticals:

Primary Outcome Measures:
  • Number of subjects with Adverse Events (AEs) as a measure of safety [ Time Frame: 29 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Pharmacokinetic analyses through plasma buprenorphine concentration in subjects as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent of subjects retained as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent of subjects reporting illicit drug use as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean total score on SOWS as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean total score on COWS as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean subjective opioid cravings scores as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean total score on Beck Depression Inventory (BDI-II) as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Patient-rated opioid use and problems Responder Analysis as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Overall satisfaction with treatment reported on Patient Satisfaction Survey [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: November 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probuphine
patients are first inducted on sublingual buprenorphine then switched to 4 Probuphine Implants
Drug: Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262261

Locations
United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90025
Synergy Clinical Research Center
National City, California, United States, 91950
North County Clinical Research
Oceanside, California, United States, 92056
Friends Research Institute
Torrance, California, United States, 90502
United States, Florida
Amit Vijapura, MD
Jacksonville, Florida, United States, 32256
Operation PAR, Inc. - TC Campus
Largo, Florida, United States, 33771
Fidelity Clinical Research
Lauderhill, Florida, United States, 33319
Scientific Clinical Research, Inc.
North Miami, Florida, United States, 33161
United States, Maryland
BPRU, Behavioral Biology Research Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Stanley Street Treatment and Resources, Inc
Fall River, Massachusetts, United States, 02720
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
United States, Missouri
Psych Care Consultants Research
St. Louis, Missouri, United States, 63128
United States, New York
St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10025
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Carolina Clinical Trials, Inc.
Charleston, South Carolina, United States, 29407
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
United States, Washington
Providence Behavioral Health Services
Everett, Washington, United States, 98201
Sponsors and Collaborators
Titan Pharmaceuticals
Investigators
Principal Investigator: Katherine L. Beebe, Ph.D. Titan Pharmaceuticals
  More Information

Additional Information:
Publications:
Responsible Party: Titan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01262261     History of Changes
Other Study ID Numbers: PRO-811
Study First Received: December 15, 2010
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Titan Pharmaceuticals:
opioid dependence
opioid addiction
buprenorphine
implant
methadone
heroin
suboxone
opioid pain medication
opioid withdrawal

Additional relevant MeSH terms:
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014