Re-Treatment Study of Probuphine in Opioid Addiction
This study has been completed.
Sponsor:
Titan Pharmaceuticals
Information provided by (Responsible Party):
Titan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01262261
First received: December 15, 2010
Last updated: January 25, 2013
Last verified: October 2012
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Purpose
Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a 6-month, open-label, re-treatment study that will confirm the safety and efficacy of Probuphine in patients who have previously completed the 6-month PRO-806 study with either Probuphine, placebo or sublingual buprenorphine.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid Dependency |
Drug: Probuphine (buprenorphine implant) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3, Six-Month, Open-Label, Re-Treatment Study of Probuphine in Opioid Addiction |
Resource links provided by NLM:
Further study details as provided by Titan Pharmaceuticals:
Primary Outcome Measures:
- Number of subjects with Adverse Events (AEs) as a measure of safety [ Time Frame: 29 weeks ] [ Designated as safety issue: Yes ]AEs that occurred after the signing of the informed consent until 4 weeks after the implants have been removed were followed. Serious AEs and AEs that were designated as possibly related to study drug were followed until resolution or stabilization.
Secondary Outcome Measures:
- Pharmacokinetic analyses through plasma buprenorphine concentration in subjects as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Percent of subjects retained as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Percent of subjects reporting illicit drug use as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Mean total score on SOWS as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Mean total score on COWS as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Mean subjective opioid cravings scores as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Mean total score on Beck Depression Inventory (BDI-II) as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Patient-rated opioid use and problems Responder Analysis as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Overall satisfaction with treatment reported on Patient Satisfaction Survey [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 85 |
| Study Start Date: | November 2010 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Probuphine
patients are first inducted on sublingual buprenorphine then switched to 4 Probuphine Implants
|
Drug: Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject has voluntarily provided written informed consent prior to conducting any study-related procedures
- Completion of 24 weeks of treatment in PRO-806
- Subject has been deemed appropriate for entry into this extension study by the investigator
- Females of childbearing potential must be willing to use a reliable means of contraception during the entire study.
Exclusion Criteria:
- An aspartate aminotransferase (AST) levels ≥ 3 X the upper limit of normal, alanine aminotransferase (ALT) levels ≥ 3 X the upper limit of normal, total bilirubin ≥ 1.5 X the upper limit of normal, or creatinine ≥ 1.5 X upper limit of normal on the screening laboratory assessments
- A current diagnosis of chronic pain requiring opioids for treatment
- A pregnant or lactating female
- 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)
- A history of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin
- A 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
- Any 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262261
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 | |
| 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 | |
| Stanley Street Treatment and Resources, Inc | |
| Fall River, Massachusetts, United States, 02720 | |
| United States, Mississippi | |
| Precise Research Centers | |
| Flowood, Mississippi, United States, 39232 | |
| United States, Missouri | |
| Psych Care Consultants Research | |
| St. Louis, Missouri, United States, 63128 | |
| United States, New York | |
| St. Luke's Roosevelt Hospital Center | |
| New York, New York, United States, 10025 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27705 | |
| 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:
Publications:
| Responsible Party: | Titan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01262261 History of Changes |
| Other Study ID Numbers: | PRO-811 |
| Study First Received: | December 15, 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:
|
Behavior, Addictive Compulsive Behavior Impulsive Behavior 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 June 13, 2013