Trial record 9 of 414 for:    United States, Vermont | University of Vermont

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Titan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01114308
First received: April 27, 2010
Last updated: January 25, 2013
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Opioid Dependency
Drug: Probuphine (buprenorphine implant)
Drug: placebo implant
Drug: Buprenorphine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo and Active-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence

Resource links provided by NLM:


Further study details as provided by Titan Pharmaceuticals:

Primary Outcome Measures:
  • CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24 [ Time Frame: 1-24 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1-24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CDF of the percent of urine samples negative for opioids from weeks 1-16 [ Time Frame: 1-16 weeks ] [ Designated as safety issue: No ]
  • CDF of the percent of urine samples negative for opioids from weeks 17-24 [ Time Frame: 17-24 weeks ] [ Designated as safety issue: No ]
  • Difference of proportion of urine samples negative for illicit opioids over 24 weeks of treatment for Probuphine vs. SL BPN [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Percent urines negative for illicit opioids [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent of study completers [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean total score on the SOWS [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean total score on the COWS [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean subjective opioid craving assessment using Visual Analog Scale (VAS) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Patient-rated Clinical Global Improvement (CGI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Physician-rated Clinical Global Improvement (CGI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean total number of weeks of abstinence [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean maximum period of continuous abstinence [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 287
Study Start Date: April 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probuphine
Patients are first inducted on SL BPN then switched to 4 buprenorphine implants
Drug: Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
Placebo Comparator: placebo implant
patients are first inducted on SL BPN then switched to 4 placebo implants
Drug: placebo implant
Implant contains ethylene vinyl acetate
Active Comparator: sublingual buprenorphine
patients are inducted on SL BPN, then continue on SL BPN
Drug: Buprenorphine
sublingual buprenorphine/naloxone tablets
Other Name: Suboxone

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114308

Locations
United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90025
Synergy Clinical Research Center
National City, California, United States, 91950
North County Clinical Research
Oceanside, California, United States, 92056
Friends Research Institute
Torrance, California, United States, 90502
United States, Florida
Jacksonville, Florida, United States, 32256
Operation PAR, Inc. - TC Campus
Largo, Florida, United States, 33771
Fidelity Clinical Research, Inc.
Lauderhill, Florida, United States, 33319
Scientific Clinical Research, Inc.
North Miami, Florida, United States, 33161
United States, Maryland
BPRU, Behavioral Biology Research Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
SSTAR: Stanley Street Treatment and Resources, Inc.
Fall River, Massachusetts, United States, 02720-6009
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
United States, Missouri
PsychCare Consultants Research
St. Louis, Missouri, United States, 63128
United States, New York
New York VA Medical Center, NYU School of Medicine
New York, New York, United States, 10010
St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10025
United States, North Carolina
Duke University, Duke Addictions Program
Durham, North Carolina, United States, 27705
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45220
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Carolina Clinical Trials, Inc.
Charleston, South Carolina, United States, 29407
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
United States, Washington
Providence Behavioral Health Services
Everett, Washington, United States, 98201
Sponsors and Collaborators
Titan Pharmaceuticals
Investigators
Principal Investigator: Katherine L. Beebe, Ph.D. Titan Pharmaceuticals
  More Information

Additional Information:
No publications provided by Titan Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Titan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01114308     History of Changes
Other Study ID Numbers: PRO-806, 1RC2DA028910-01
Study First Received: April 27, 2010
Last Updated: January 25, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Titan Pharmaceuticals:
opioid dependence
opioid addiction
buprenorphine
implant
methadone
heroin
suboxone
opioid pain medication
opioid withdrawal

Additional relevant MeSH terms:
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on April 15, 2014