Ignite Creation Date:
2024-05-05 @ 11:35 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01366001
Status:
COMPLETED
Last Update Posted:
2012-03-09
First Post:
2011-06-02
Brief Title:
ALK33BUP-101 Safety and Pharmacodynamic Effects of ALKS 33-BUP Administered Alone and When Co-administered With Cocaine
Sponsor:
Alkermes Inc
Organization:
Alkermes Inc
Study Overview
Official Title:
A Phase 1 Multiple-dose Parallel Group Study to Evaluate the Safety and Pharmacodynamic Effects of RDC-0313-buprenorphine ALKS 33-BUP Administered Alone and Co-administered With Cocaine to Opioid-experienced Cocaine Abusers
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and tolerability of ALKS33-BUP when administered to opioid-experienced cocaine abusers
Detailed Description:
There are no currently available pharmacologic treatments for cocaine abuse andor dependence and the unmet medical need is growing In collaboration with the National Institute on Drug Abuse NIDA Alkermes Inc is investigating a fixed-dose combination product consisting of ALKS 33 also referred to as RDC-0313 and buprenorphine ALKS 33-BUP for the treatment of cocaine abuse andor dependence Grant Number R01DA031000
This is a randomized double-blind placebo-controlled parallel design inpatient study Eligibility will be established which includes responses to cocaine infusions at baseline prior to study drug administration Approximately 30 opioid-experienced cocaine abusers will be randomized 111 to receive study drug Study drug will be administered once daily for 10 consecutive days Pharmacodynamic assessments and drug-drug interactions will be closely monitored during the study Following study drug administration subjects will receive cocaine infusions to evaluate the effect of treatment on the subjective effects and the PKPD of cocaine Subjects will be discharged from the clinical research unit 2 days after the last infusion of cocaine Subjects will return for follow-up between 7 and 14 days after discharge The full study will take subjects approximately 28 days with 17 days of inpatient stay
This is a randomized double-blind placebo-controlled parallel design inpatient study Eligibility will be established which includes responses to cocaine infusions at baseline prior to study drug administration Approximately 30 opioid-experienced cocaine abusers will be randomized 111 to receive study drug Study drug will be administered once daily for 10 consecutive days Pharmacodynamic assessments and drug-drug interactions will be closely monitored during the study Following study drug administration subjects will receive cocaine infusions to evaluate the effect of treatment on the subjective effects and the PKPD of cocaine Subjects will be discharged from the clinical research unit 2 days after the last infusion of cocaine Subjects will return for follow-up between 7 and 14 days after discharge The full study will take subjects approximately 28 days with 17 days of inpatient stay
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA031000 | NIH | None | httpsreporternihgovquickSearchR01DA031000 |