A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction
This study has been completed.
Sponsor:
Titan Pharmaceuticals
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
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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
| 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 May 19, 2013