A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction

Condition(s) targeted: Opioid Dependency

Intervention: Probuphine (buprenorphine implant) (Drug); placebo implant (Drug); Buprenorphine (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

Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.

Official title: A Randomized, Placebo and Active-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24

CDF of the percent of urine samples negative for opioids from weeks 1-24 with imputation based on illicit drug use self-report data for Probuphine and placebo groups

Secondary outcome:

CDF of the percent of urine samples negative for opioids from weeks 1-16

CDF of the percent of urine samples negative for opioids from weeks 17-24

Difference of proportion of urine samples negative for illicit opioids over 24 weeks of treatment for Probuphine vs. SL BPN

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

Criteria:

Inclusion Criteria:

- Voluntarily provide written informed consent prior to the conduct of any

study-related procedures

- Male or female, 18-65 years of age

- Meet DSM-IV-TR criteria for current opioid dependence

- Females of childbearing potential or a fertile male, must use a reliable means of

contraception Exclusion Criteria:

- Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)

- Received any medication-assisted treatment for opioid dependence (e. g., methadone,

BPN) within the previous 90 days

- Current diagnosis of chronic pain requiring opioids for treatment

- Candidates for short-term opioid treatment (<6 months) only, or opioid detoxification

therapy

- Pregnant or lactating female?

- Previous hypersensitivity or allergy to BPN, EVA-containing substances, or naloxone

- 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)

- History of coagulopathy within the past 90 days, and/or current anti-coagulant

therapy such as warfarin

- Meet the DSM-IV-TR criteria for dependence on any other psychoactive substances other

than opioids or nicotine (e. g., alcohol, sedatives)

- 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

- 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

- Exposure to any investigational drug within the previous 8 weeks

- Previous exposure to Probuphine, or prior implantation with a placebo implant in the

context of a Probuphine clinical trial

- Presence of aspartate aminotransferase (AST) levels greater than or equal to 3 X the

upper limit of normal, alanine aminotransferase (ALT) levels greater than or equal to 3 X the upper limit of normal, total bilirubin greater than or equal to 1. 5 X the upper limit of normal, or creatinine greater than 1. 5 X upper limit of normal on the screening laboratory assessments

- Clinically significant low platelet count on the screening laboratory assessments

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, Inc., 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

SSTAR: Stanley Street Treatment and Resources, Inc., Fall River, Massachusetts 02720-6009, United States

Precise Research Centers, Flowood, Mississippi 39232, United States

PsychCare Consultants Research, St. Louis, Missouri 63128, United States

New York VA Medical Center, NYU School of Medicine, New York, New York 10010, United States

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

Duke University, Duke Addictions Program, Durham, North Carolina 27705, United States

University of Cincinnati, Cincinnati, Ohio 45220, 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

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