Ignite Creation Date:
2024-05-05 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00781898
Status:
COMPLETED
Last Update Posted:
2017-10-23
First Post:
2008-10-24
Brief Title:
Treatment Study Using Depot Naltrexone 16 Philadelphia CoordData Mgmt Site
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Prevention of Relapse to Opioid Addiction Using Depot Naltrexone
Status:
COMPLETED
Status Verified Date:
2017-09
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 aim of this project is to conduct a multi-site effectiveness study to determine whether the addition of a monthly injection of depot naltrexone to treatment as usual TAU will significantly improve outcome in parolees and probationers with a history of opioid addiction compared to TAU alone Participants will be randomized to either treatment as usual in community programs or monthly injections of depot naltrexone for six months with treatment as usual in community programs The effectiveness of depot naltrexone has never been studied in opioid dependent parolees all parolee subjects will be evaluated at baseline while in treatment and at 6 12 and 18 month post entry time points The primary study outcomes are retention in treatment drug use re-arrests psychosocial and medicalpsychiatric functioning and economic costs and benefit costs of naltrexone
Detailed Description:
This site serves as the coordinating center for five sites conducting the trial under the same IND and same protocol
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 |
|---|---|---|---|
| R01DA024553 | NIH | None | httpsreporternihgovquickSearchR01DA024553 |