Re-Treatment Study of Probuphine in Opioid Addiction

Opioid Dependency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262261
• Other study ID #: PRO-811
• Status: Completed
• Phase: Phase 3
• Start date: November 2010
• Est. completion date: November 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Opioid Dependency

Intervention

Drug:
• Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.

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	Duke University Medical Center	Durham	North Carolina
United States	Providence Behavioral Health Services	Everett	Washington
United States	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	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	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	Psych Care Consultants Research	Saint Louis	Missouri
United States	Friends Research Institute	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Titan Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with Adverse Events (AEs) as a measure of safety	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.	29 weeks
Secondary	Pharmacokinetic analyses through plasma buprenorphine concentration in subjects as a measure of efficacy		24 weeks
Secondary	Percent of subjects retained as a measure of efficacy		24 weeks
Secondary	Percent of subjects reporting illicit drug use as a measure of efficacy		24 weeks
Secondary	Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy		24 weeks
Secondary	Mean total score on SOWS as a measure of efficacy		24 weeks
Secondary	Mean total score on COWS as a measure of efficacy		24 weeks
Secondary	Mean subjective opioid cravings scores as a measure of efficacy		24 weeks
Secondary	Mean total score on Beck Depression Inventory (BDI-II) as a measure of efficacy		24 weeks
Secondary	Patient-rated opioid use and problems Responder Analysis as a measure of efficacy		24 weeks
Secondary	Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy		24 weeks
Secondary	Overall satisfaction with treatment reported on Patient Satisfaction Survey		24 weeks

External Links

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