Clinical trial NCT00447564: Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid Dependence
Keywords: opioid dependence
opioid addiction
buprenorphine
methadone
heroin
implant
opioid withdrawal
opioid pain medication
suboxone
Lead sponsor: Titan Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-03-14
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Buprenorphine (BPN) is an approved treatment for opioid dependence, however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine is an implant placed just beneath the skin that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study will test the safety and efficacy of Probuphine in the treatment of patients with opioid dependence.


Eligibility 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 criteria for current opioid dependence
* Females of childbearing potential and fertile males must use a reliable means of contraception

Exclusion Criteria:

* Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
* Presence of aspartate aminotransferase (AST) levels ≥ 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels ≥ 3 X upper limit of normal and/or total bilirubin ≥ 1.5 X upper limit of normal and/or creatinine ≥ 1.5 X upper limit of normal
* Received treatment for opioid dependence (e.g., methadone, BPN), within the previous 90 days
* Current diagnosis of chronic pain requiring opioids for treatment
* Candidates for only short term opioid treatment or opioid detoxification therapy
* Pregnant or lactating females
* Previous hypersensitivity or allergy to BPN- or EVA-containing substances or naloxone
* Current use of agents metabolized through CYP 3A4 such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), and protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
* Current anti-coagulant therapy (such as warfarin) or an INR \> 1.2
* Meet DSM-IV criteria for current dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives)
* Current use of benzodiazepines other than physician prescribed use
* Significant medical or psychiatric symptoms or dementia which in the opinion of the Investigators would preclude compliance with the protocol, patient safety, adequate cooperation in the study, or obtaining informed consent
* Concurrent medical conditions (such as severe respiratory insufficiency) that may prevent the patient from safely participating in study; and/or any pending legal action that could prohibit participation and/or compliance in study
* Participated in a clinical study within the previous 8 weeks

Primary outcomes:
measure: The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids
timeFrame: weeks 1-16
Secondary outcomes:
measure: The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids
timeFrame: weeks 17-24
measure: Mean percent urines negative for illicit opioids
timeFrame: weeks 1-16
measure: Mean percent urines negative for illicit opioids
timeFrame: weeks 17-24
measure: Proportion (percent) of study completers
timeFrame: weeks 1-16
measure: Proportion (percent) of study completers
timeFrame: weeks 17-24
measure: Total number of weeks of abstinence
timeFrame: weeks 1-16
measure: Total number of weeks of abstinence
timeFrame: weeks 17-24
measure: Mean maximal period in weeks of continuous abstinence
timeFrame: weeks 1-16
measure: Mean maximal period in weeks of continuous abstinence
timeFrame: weeks 17-24
measure: Mean total score on the SOWS
timeFrame: weeks 1-16
measure: Mean total score on the SOWS
timeFrame: weeks 17-24
measure: Mean total score on the COWS
timeFrame: weeks 1-16
measure: Mean total score on the COWS
timeFrame: weeks 17-24
measure: Mean subjective opioid cravings assessment (VAS)
timeFrame: weeks 1-16
measure: Mean subjective opioid cravings assessment (VAS)
timeFrame: weeks 17-24
measure: Patient-rated Clinical Global Impression
timeFrame: weeks 1-16
measure: Patient-rated Clinical Global Impression
timeFrame: weeks 17-24
measure: Physician-rated Clinical Global Impression
timeFrame: weeks 1-16
measure: Physician-rated Clinical Global Impression
timeFrame: weeks 17-24
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: Jacksonville
country: United States
facility: Amit Vijapura, MD and Associates
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: Roswell
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Baltimore
country: United States
facility: Behavioral Biology Research Unit, Johns Hopkins Bayview Campus
state: Maryland
city: Fall River
country: United States
facility: Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc.
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University Department of Psychiatry and Behavioral Neurosciences
state: Michigan
city: Saint Louis
country: United States
facility: Psych Care Consultants Research
state: Missouri
city: New York
country: United States
facility: New York VA Medical Center, NYU School of Medicine
state: New York
city: New York
country: United States
facility: Addiction Institute of New York
state: New York
city: Durham
country: United States
facility: Duke University Medical Center Addictions Program
state: North Carolina
city: Oklahoma City
country: United States
facility: Pahl Pharmaceutical Research, LLC
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania Treatment Research Center
state: Pennsylvania
city: Everett
country: United States
facility: Providence Behavioral Health Services
state: Washington
city: Seattle
country: United States
facility: Puget Sound Health Care Systems
state: Washington
Study officials:
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.