Clinical trial NCT01262261: Re-Treatment Study of Probuphine in Opioid Addiction
Official title: A Phase 3, Six-Month, Open-Label, Re-Treatment Study of Probuphine in Opioid Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid Dependency
Keywords: opioid dependence
opioid addiction
buprenorphine
implant
methadone
heroin
suboxone
opioid pain medication
opioid withdrawal
Lead sponsor: Titan Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-12-17
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Number of subjects with Adverse Events (AEs) as a measure of safety
timeFrame: 29 weeks
Secondary outcomes:
measure: Pharmacokinetic analyses through plasma buprenorphine concentration in subjects as a measure of efficacy
timeFrame: 24 weeks
measure: Percent of subjects retained as a measure of efficacy
timeFrame: 24 weeks
measure: Percent of subjects reporting illicit drug use as a measure of efficacy
timeFrame: 24 weeks
measure: Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy
timeFrame: 24 weeks
measure: Mean total score on SOWS as a measure of efficacy
timeFrame: 24 weeks
measure: Mean total score on COWS as a measure of efficacy
timeFrame: 24 weeks
measure: Mean subjective opioid cravings scores as a measure of efficacy
timeFrame: 24 weeks
measure: Mean total score on Beck Depression Inventory (BDI-II) as a measure of efficacy
timeFrame: 24 weeks
measure: Patient-rated opioid use and problems Responder Analysis as a measure of efficacy
timeFrame: 24 weeks
measure: Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy
timeFrame: 24 weeks
measure: Overall satisfaction with treatment reported on Patient Satisfaction Survey
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Oceanside
country: United States
facility: North County Clinical Research
state: California
city: Torrance
country: United States
facility: Friends Research Institute
state: California
city: Jacksonville
country: United States
facility: Amit Vijapura, MD
state: Florida
city: Largo
country: United States
facility: Operation PAR, Inc. - TC Campus
state: Florida
city: Lauderhill
country: United States
facility: Fidelity Clinical Research
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research, Inc.
state: Florida
city: Baltimore
country: United States
facility: BPRU, Behavioral Biology Research Center
state: Maryland
city: Fall River
country: United States
facility: Stanley Street Treatment and Resources, Inc
state: Massachusetts
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Saint Louis
country: United States
facility: Psych Care Consultants Research
state: Missouri
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Carolina Clinical Trials, Inc.
state: South Carolina
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Everett
country: United States
facility: Providence Behavioral Health Services
state: Washington
Study officials:
affiliation: Titan Pharmaceuticals
name: Katherine L. Beebe, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.