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

Opioid Dependency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114308
• Other study ID #: PRO-806
• Secondary ID: 1RC2DA028910-01
• Status: Completed
• Phase: Phase 3
• Start date: April 2010
• Est. completion date: May 2011

Study information

• Verified date: June 2017
• Source: Titan Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Dependency

Intervention

Drug:
• Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
• placebo implant
Implant contains ethylene vinyl acetate
• Buprenorphine
sublingual buprenorphine/naloxone tablets

Locations

Country	Name	City	State
United States	BPRU, Behavioral Biology Research Center	Baltimore	Maryland
United States	University of Vermont	Burlington	Vermont
United States	Carolina Clinical Trials, Inc.	Charleston	South Carolina
United States	University of Cincinnati	Cincinnati	Ohio
United States	Duke University, Duke Addictions Program	Durham	North Carolina
United States	Providence Behavioral Health Services	Everett	Washington
United States	SSTAR: Stanley Street Treatment and Resources, Inc.	Fall River	Massachusetts
United States	Precise Research Centers	Flowood	Mississippi
United States	Amit Vijapura, MD	Jacksonville	Florida
United States	Operation PAR, Inc. - TC Campus	Largo	Florida
United States	Fidelity Clinical Research, Inc.	Lauderhill	Florida
United States	David Geffen School of Medicine at UCLA	Los Angeles	California
United States	Synergy Clinical Research Center	National City	California
United States	New York VA Medical Center, NYU School of Medicine	New York	New York
United States	St. Luke's Roosevelt Hospital Center	New York	New York
United States	Scientific Clinical Research, Inc.	North Miami	Florida
United States	North County Clinical Research	Oceanside	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	PsychCare Consultants Research	Saint Louis	Missouri
United States	Friends Research Institute	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Titan Pharmaceuticals	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent urines negative for illicit opioids		24 weeks
Other	Percent of study completers		24 weeks
Other	Mean total score on the SOWS		24 weeks
Other	Mean total score on the COWS		24 weeks
Other	Mean subjective opioid craving assessment using Visual Analog Scale (VAS)		24 weeks
Other	Patient-rated Clinical Global Improvement (CGI)		24 weeks
Other	Physician-rated Clinical Global Improvement (CGI)		24 weeks
Other	Mean total number of weeks of abstinence		24 weeks
Other	Mean maximum period of continuous abstinence		24 weeks
Primary	CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24		1-24 weeks
Primary	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		1-24 weeks
Secondary	CDF of the percent of urine samples negative for opioids from weeks 1-16		1-16 weeks
Secondary	CDF of the percent of urine samples negative for opioids from weeks 17-24		17-24 weeks
Secondary	Difference of proportion of urine samples negative for illicit opioids over 24 weeks of treatment for Probuphine vs. SL BPN		24 weeks

External Links

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