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

Primary Purpose

Opioid Dependency

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Probuphine (buprenorphine implant)
placebo implant
Buprenorphine
Sponsored by
Titan Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Dependency focused on measuring opioid dependence, opioid addiction, buprenorphine, implant, methadone, heroin, suboxone, opioid pain medication, opioid withdrawal

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • David Geffen School of Medicine at UCLA
  • Synergy Clinical Research Center
  • North County Clinical Research
  • Friends Research Institute
  • Amit Vijapura, MD
  • Operation PAR, Inc. - TC Campus
  • Fidelity Clinical Research, Inc.
  • Scientific Clinical Research, Inc.
  • BPRU, Behavioral Biology Research Center
  • SSTAR: Stanley Street Treatment and Resources, Inc.
  • Precise Research Centers
  • PsychCare Consultants Research
  • New York VA Medical Center, NYU School of Medicine
  • St. Luke's Roosevelt Hospital Center
  • Duke University, Duke Addictions Program
  • University of Cincinnati
  • University of Pennsylvania
  • Carolina Clinical Trials, Inc.
  • University of Vermont
  • Providence Behavioral Health Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Probuphine

placebo implant

sublingual buprenorphine

Arm Description

Patients are first inducted on SL BPN then switched to 4 buprenorphine implants

patients are first inducted on SL BPN then switched to 4 placebo implants

patients are inducted on SL BPN, then continue on SL BPN

Outcomes

Primary Outcome Measures

CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24
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

Secondary Outcome Measures

CDF of the percent of urine samples negative for opioids from weeks 1-16
CDF of the percent of urine samples negative for opioids from weeks 17-24
Difference of proportion of urine samples negative for illicit opioids over 24 weeks of treatment for Probuphine vs. SL BPN

Full Information

First Posted
April 27, 2010
Last Updated
December 27, 2018
Sponsor
Titan Pharmaceuticals
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01114308
Brief Title
A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction
Official Title
A Randomized, Placebo and Active-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Titan Pharmaceuticals
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependency
Keywords
opioid dependence, opioid addiction, buprenorphine, implant, methadone, heroin, suboxone, opioid pain medication, opioid withdrawal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
287 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probuphine
Arm Type
Experimental
Arm Description
Patients are first inducted on SL BPN then switched to 4 buprenorphine implants
Arm Title
placebo implant
Arm Type
Placebo Comparator
Arm Description
patients are first inducted on SL BPN then switched to 4 placebo implants
Arm Title
sublingual buprenorphine
Arm Type
Active Comparator
Arm Description
patients are inducted on SL BPN, then continue on SL BPN
Intervention Type
Drug
Intervention Name(s)
Probuphine (buprenorphine implant)
Intervention Description
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
Intervention Type
Drug
Intervention Name(s)
placebo implant
Intervention Description
Implant contains ethylene vinyl acetate
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Other Intervention Name(s)
Suboxone
Intervention Description
sublingual buprenorphine/naloxone tablets
Primary Outcome Measure Information:
Title
CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24
Time Frame
1-24 weeks
Title
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
Secondary Outcome Measure Information:
Title
CDF of the percent of urine samples negative for opioids from weeks 1-16
Time Frame
1-16 weeks
Title
CDF of the percent of urine samples negative for opioids from weeks 17-24
Time Frame
17-24 weeks
Title
Difference of proportion of urine samples negative for illicit opioids over 24 weeks of treatment for Probuphine vs. SL BPN
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Percent urines negative for illicit opioids
Time Frame
24 weeks
Title
Percent of study completers
Time Frame
24 weeks
Title
Mean total score on the SOWS
Time Frame
24 weeks
Title
Mean total score on the COWS
Time Frame
24 weeks
Title
Mean subjective opioid craving assessment using Visual Analog Scale (VAS)
Time Frame
24 weeks
Title
Patient-rated Clinical Global Improvement (CGI)
Time Frame
24 weeks
Title
Physician-rated Clinical Global Improvement (CGI)
Time Frame
24 weeks
Title
Mean total number of weeks of abstinence
Time Frame
24 weeks
Title
Mean maximum period of continuous abstinence
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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-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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine L. Beebe, Ph.D.
Organizational Affiliation
Titan Pharmaceuticals
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Synergy Clinical Research Center
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
North County Clinical Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Friends Research Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Amit Vijapura, MD
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Operation PAR, Inc. - TC Campus
City
Largo
State/Province
Florida
ZIP/Postal Code
33771
Country
United States
Facility Name
Fidelity Clinical Research, Inc.
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Scientific Clinical Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
BPRU, Behavioral Biology Research Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
SSTAR: Stanley Street Treatment and Resources, Inc.
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720-6009
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
PsychCare Consultants Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
New York VA Medical Center, NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
St. Luke's Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Duke University, Duke Addictions Program
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Carolina Clinical Trials, Inc.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Providence Behavioral Health Services
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23919595
Citation
Rosenthal RN, Ling W, Casadonte P, Vocci F, Bailey GL, Kampman K, Patkar A, Chavoustie S, Blasey C, Sigmon S, Beebe KL. Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone. Addiction. 2013 Dec;108(12):2141-9. doi: 10.1111/add.12315. Epub 2013 Sep 18.
Results Reference
derived
Links:
URL
http://www.titanpharm.com
Description
Related Info

Learn more about this trial

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

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