Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218127
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-09-16
Brief Title:
Treatment of OpioidHeroin Dependence Comparison of Three Medication Dosing Regimens
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Opioid Maintenance Optimum Stabilization and Withdrawal
Status:
COMPLETED
Status Verified Date:
2016-10
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:
Heroin dependence remains a major addiction problem in the United States The purpose of this study is to determine the effectiveness of levoacetyl methadol ORLAAM in treating heroin dependent individuals
Detailed Description:
Heroin is a highly addictive drug and its abuse has both medical and social consequences ORLAAM is approved to treat both opiate and narcotic dependence The purpose of this study is to determine the efficacy of ORLAAM in treating heroin dependent individuals In addition this study will determine the most effective dosing regimen of ORLAAM
This study will last 20 weeks Participants will be randomly assigned to receive one of three dosing conditions 1 standard fixed dose 2 dose-by-weight and 3 dose effect The dose effect condition will include a dose of ORLAAM dependent on opiate use and withdrawal symptoms associated with opiate use doses may be adjusted throughout the study All participants will receive cognitive behavioral therapy throughout the study
This study will last 20 weeks Participants will be randomly assigned to receive one of three dosing conditions 1 standard fixed dose 2 dose-by-weight and 3 dose effect The dose effect condition will include a dose of ORLAAM dependent on opiate use and withdrawal symptoms associated with opiate use doses may be adjusted throughout the study All participants will receive cognitive behavioral therapy throughout the study
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 |
|---|---|---|---|
| DPMC | None | None | None |
| R01-13664-1 | None | None | None |