Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310934
Status:
COMPLETED
Last Update Posted:
2006-10-24
First Post:
2006-04-03
Brief Title:
A Stepwise Strategy Utilizing Buprenorphine and Methadone
Sponsor:
Karolinska University Hospital
Organization:
Karolinska University Hospital
Study Overview
Official Title:
Graded Strategy for Pharmacological Treatment of Heroin Dependence
Status:
COMPLETED
Status Verified Date:
2006-03
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 objective of this study is to compare optimally given methadone maintenance treatment MMT for heroin dependence with a novel sequential strategy where patients are offered buprenorphine as first line treatment allowed dose adjustments as needed and switched to methadone if the maximal dose of buprenorphine is insufficient
Detailed Description:
The objective of this study is to compare optimally given methadone maintenance treatment MMT for heroin dependence with a novel sequential strategy STEP where patients are offered buprenorphine as first line treatment allowed dose adjustments as needed and switched to methadone if the maximal dose of buprenorphine is insufficient
For this purpose 96 subjects at two centers Uppsala and Stockholm are randomized to MMT or STEP and followed for 6 months Retention in treatment is the primary outcome Secondary outcomes in completers are proportion urine samples free of illicit opiates on app twice weekly sampling and problem severity as measured by a semistructured interview the Addiction Severity Index ASI at baseline and after 3 and 6 months
For this purpose 96 subjects at two centers Uppsala and Stockholm are randomized to MMT or STEP and followed for 6 months Retention in treatment is the primary outcome Secondary outcomes in completers are proportion urine samples free of illicit opiates on app twice weekly sampling and problem severity as measured by a semistructured interview the Addiction Severity Index ASI at baseline and after 3 and 6 months
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