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Re-Treatment Study of Probuphine in Opioid Addiction

Information source: Titan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opioid Dependency

Intervention: Probuphine (buprenorphine implant) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Titan Pharmaceuticals

Official(s) and/or principal investigator(s):
Katherine L. Beebe, Ph.D., Principal Investigator, Affiliation: Titan Pharmaceuticals

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of subjects with Adverse Events (AEs) as a measure of safety

Secondary outcome:

Pharmacokinetic analyses through plasma buprenorphine concentration in subjects as a measure of efficacy

Percent of subjects retained as a measure of efficacy

Percent of subjects reporting illicit drug use as a measure of efficacy

Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy

Mean total score on SOWS as a measure of efficacy

Mean total score on COWS as a measure of efficacy

Mean subjective opioid cravings scores as a measure of efficacy

Mean total score on Beck Depression Inventory (BDI-II) as a measure of efficacy

Patient-rated opioid use and problems Responder Analysis as a measure of efficacy

Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy

Overall satisfaction with treatment reported on Patient Satisfaction Survey

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

David Geffen School of Medicine at UCLA, Los Angeles, California 90025, United States

Synergy Clinical Research Center, National City, California 91950, United States

North County Clinical Research, Oceanside, California 92056, United States

Friends Research Institute, Torrance, California 90502, United States

Amit Vijapura, MD, Jacksonville, Florida 32256, United States

Operation PAR, Inc. - TC Campus, Largo, Florida 33771, United States

Fidelity Clinical Research, Lauderhill, Florida 33319, United States

Scientific Clinical Research, Inc., North Miami, Florida 33161, United States

BPRU, Behavioral Biology Research Center, Baltimore, Maryland 21224, United States

Stanley Street Treatment and Resources, Inc, Fall River, Massachusetts 02720, United States

Precise Research Centers, Flowood, Mississippi 39232, United States

Psych Care Consultants Research, St. Louis, Missouri 63128, United States

St. Luke's Roosevelt Hospital Center, New York, New York 10025, United States

Duke University Medical Center, Durham, North Carolina 27705, United States

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Carolina Clinical Trials, Inc., Charleston, South Carolina 29407, United States

University of Vermont, Burlington, Vermont 05401, United States

Providence Behavioral Health Services, Everett, Washington 98201, United States

Additional Information

Related publications:

Ling W, Casadonte P, Bigelow G, Kampman KM, Patkar A, Bailey GL, Rosenthal RN, Beebe KL. Buprenorphine implants for treatment of opioid dependence: a randomized controlled trial. JAMA. 2010 Oct 13;304(14):1576-83. doi: 10.1001/jama.2010.1427.

White J, Bell J, Saunders JB, Williamson P, Makowska M, Farquharson A, Beebe KL. Open-label dose-finding trial of buprenorphine implants (Probuphine) for treatment of heroin dependence. Drug Alcohol Depend. 2009 Jul 1;103(1-2):37-43. doi: 10.1016/j.drugalcdep.2009.03.008. Epub 2009 Apr 28.

Starting date: November 2010
Last updated: October 6, 2014

Page last updated: August 23, 2015

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