Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects
This study is currently recruiting participants.
Verified October 2012 by Reckitt Benckiser Pharmaceuticals Inc.
Sponsor:
Reckitt Benckiser Pharmaceuticals Inc.
Information provided by (Responsible Party):
Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01738503
First received: November 28, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
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Purpose
This is an open-label study in treatment seeking opioid-dependent subjects for safety, tolerability, pharmacokinetics, and efficacy markers of subcutaneous injections of depot buprenorphine after induction and stabilization of treatment seeking subjects onto Subutex.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid Related Disorder |
Drug: RBP-6000 Drug: SC injection of RBP-6000 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Multicenter, Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy Markers of Subcutaneous Injections of Depot Buprenorphine (RBP-6000) in Treatment Seeking Opioid-Dependent Subjects |
Resource links provided by NLM:
Further study details as provided by Reckitt Benckiser Pharmaceuticals Inc.:
Primary Outcome Measures:
- To compare the steady state PK of buprenorphine and norbuprenorphine after SC doses of RBP- 6000 relative to the corresponding SUBUTEX doses [ Time Frame: 113 days ] [ Designated as safety issue: No ]Multiple dose pharmacokinetics (PK) of buprenorphine and norbuprenorphine after SC injections of 50 mg, 100 mg, and 200 mg doses of buprenorphine in RBP-6000 in treatment seeking opioid-dependent subjects who will be inducted and then stabilized on a SUBUTEX dose of 8 mg, 12 mg, or 24 mg, respectively.
Secondary Outcome Measures:
- The Clinical Opiate Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS), Opioid Craving Visual Analog Scale (VAS), and Clinical Global Impression total scores. [ Time Frame: 113 ] [ Designated as safety issue: No ]The Clinical Opiate Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS), Opioid Craving Visual Analog Scale (VAS), Clinical Global Impression - Severity scale (CGIS), and Clinical Global Impression - Improvement scale (CGI-I) total scores.
Other Outcome Measures:
- To assess the safety of multiple subcutaneous (SC) injections of 50 mg, 100 mg and 200 mg doses of buprenorphine in RBP-6000 in treatment seeking opioid-dependent subjects who will be inducted and then stabilized on a sublingual SUBUTEX doses. [ Time Frame: 113 ] [ Designated as safety issue: Yes ]To assess the safety and tolerability of multiple subcutaneous (SC) injections of 50 mg, 100 mg and 200 mg doses of buprenorphine in RBP-6000 in treatment seeking opioid-dependent subjects who will be inducted and then stabilized on a sublingual SUBUTEX dose of 8 mg, 12 mg, or 24 mg prior to transfer.
| Estimated Enrollment: | 45 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: RBP-6000
Subcutaneous (SC) injections containing RBP-6000 50 mg at 28 day intervals
|
Drug: RBP-6000
18% Buprenorphine Sterile Solution for subcutaneous (SC) injection
Drug: SC injection of RBP-6000
|
|
Active Comparator: RB-6000
Subcutaneous injections containing 100 mg at 28 day intervals
|
Drug: RBP-6000
18% Buprenorphine Sterile Solution for subcutaneous (SC) injection
Drug: SC injection of RBP-6000
|
|
Active Comparator: SC injections containing RBP-6000 50mg
Subcutaneous (SC) injections containing RBP-6000 200mg at 28 day intervals
|
Drug: RBP-6000
18% Buprenorphine Sterile Solution for subcutaneous (SC) injection
Drug: SC injection of RBP-6000
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female subjects
- Agree not to take any buprenorphine products other than those administered for the current study throughout participation in the study
- Body mass index (BMI) of >18.0 to < 33.0 kg/m
Exclusion Criteria:
- Participants with a current diagnosis requiring chronic opioid treatment
- Participants with a history of risk factors of Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or an ECG demonstrating a Fridericia's corrected QT interval (QTcF) >450 msec in males and QTcF > 470 in females at screening
- Abuse of buprenorphine or use of buprenorphine within 14 days of informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738503
Contacts
| Contact: Heather D Sutton | 804-423-8961 |
Locations
| United States, Kansas | |
| Vince and Associates Clinical Research | Recruiting |
| Overland Park, Kansas, United States, 66212 | |
| Contact: Bradley D Vince, DO 913-696-1601 | |
| Principal Investigator: Bradley D. Vince, DO | |
| Sub-Investigator: Steven G Hull, MD | |
Sponsors and Collaborators
Reckitt Benckiser Pharmaceuticals Inc.
Investigators
| Principal Investigator: | Bradley D Vince, DO | Vince and Associates Clinical Research |
More Information
No publications provided
| Responsible Party: | Reckitt Benckiser Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT01738503 History of Changes |
| Other Study ID Numbers: | RB-US-12-0005 |
| Study First Received: | November 28, 2012 |
| Last Updated: | November 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Reckitt Benckiser Pharmaceuticals Inc.:
|
Opioid Dependence, Buprenorphine, Depot, SUBUTEX, RBP-6000 |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders 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 17, 2013