Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175357
Status:
COMPLETED
Last Update Posted:
2014-09-29
First Post:
2005-09-09
Brief Title:
NAOMI A Study to Compare Medically-prescribed Heroin With Oral Methadone in Chronic Opiate Addiction
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
North American Opiate Medication Initiative NAOMI Multi-Centre Randomized Controlled Trial of Heroin-Assisted Therapy for Treatment-Refractory Injection Opiate Users
Status:
COMPLETED
Status Verified Date:
2014-09
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 objective of this study is to determine whether the closely supervised provision of injectable pharmaceutical-grade heroin in combination with oral methadone is more effective than methadone therapy alone in recruiting retaining and benefiting long-term heroin users who have not been helped by current standard treatment options
Detailed Description:
This is a two-centre Vancouver Montreal RCT involving a total of 235 volunteers Eligible participants will be randomized to injectable heroin combined with oral methadone as desired 45 versus oral methadone alone 45 A subset of 10 will be randomized to injectable hydromorphone Dilaudid Hydromorphone and heroin will be given in a double-blind fashion the purpose is to permit validation of reported illicit use of heroin through urine testing in the hydromorphone group Research visits will be conducted quarterly and will occur independently of treatment clinic visits Incentives will be used to maintain research follow-up whether or not the subject is retained in treatment The analysis will be under intent-to-treat The primary outcomes of interest are 1 recruitment and retention in the study and 2 illicit drug use and criminal behavior as determined by the Europ-ASI at 12 months Secondary outcomes are measures of social function eg social integration and functioning quality of life and cost-benefiteffectiveness of the interventions
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 |
|---|---|---|---|
| 03-2316 | None | None | None |