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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01114308
Recruitment Status : Completed
First Posted : May 3, 2010
Last Update Posted : June 14, 2017
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Braeburn Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Opioid Dependency Drug: Probuphine (buprenorphine implant) Drug: placebo implant Drug: Buprenorphine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo and Active-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence
Study Start Date : April 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24 [ Time Frame: 1-24 weeks ]
  2. 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 Measures :
  1. CDF of the percent of urine samples negative for opioids from weeks 1-16 [ Time Frame: 1-16 weeks ]
  2. CDF of the percent of urine samples negative for opioids from weeks 17-24 [ Time Frame: 17-24 weeks ]
  3. 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 Outcome Measures:
  1. Percent urines negative for illicit opioids [ Time Frame: 24 weeks ]
  2. Percent of study completers [ Time Frame: 24 weeks ]
  3. Mean total score on the SOWS [ Time Frame: 24 weeks ]
  4. Mean total score on the COWS [ Time Frame: 24 weeks ]
  5. Mean subjective opioid craving assessment using Visual Analog Scale (VAS) [ Time Frame: 24 weeks ]
  6. Patient-rated Clinical Global Improvement (CGI) [ Time Frame: 24 weeks ]
  7. Physician-rated Clinical Global Improvement (CGI) [ Time Frame: 24 weeks ]
  8. Mean total number of weeks of abstinence [ Time Frame: 24 weeks ]
  9. Mean maximum period of continuous abstinence [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01114308

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
Amit Vijapura, MD
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
Saint 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
Braeburn Pharmaceuticals
National Institute on Drug Abuse (NIDA)
Principal Investigator: Katherine L. Beebe, Ph.D. Titan Pharmaceuticals

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Braeburn Pharmaceuticals Identifier: NCT01114308     History of Changes
Other Study ID Numbers: PRO-806
1RC2DA028910-01 ( U.S. NIH Grant/Contract )
First Posted: May 3, 2010    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

Keywords provided by Braeburn Pharmaceuticals:
opioid dependence
opioid addiction
opioid pain medication
opioid withdrawal

Additional relevant MeSH terms:
Analgesics, Opioid
Buprenorphine, Naloxone Drug Combination
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists