Project 170813

Study to Assess Longer-term Opioid Medication Effectiveness (SALOME): Multi-centre, double blind Randomized Controlled Trial comparing the efficacy of Diacetylmorphine vs. Hydromorphone for the treatment of long-term Injection Opiate Users who do not benefit from available therapies

170813

Study to Assess Longer-term Opioid Medication Effectiveness (SALOME): Multi-centre, double blind Randomized Controlled Trial comparing the efficacy of Diacetylmorphine vs. Hydromorphone for the treatment of long-term Injection Opiate Users who do not benefit from available therapies

$999,997
Project Information
Study Type: Trial Randomized_Controlled_Trial
Therapeutic Area: Addiction
Research Theme: Clinical
Disease Area: opioid dependence, heroin addiction
Data Type: Canadian
Institution & Funding
Principal Investigator(s): Krausz, Reinhard M; Oviedo-Joekes, Eugenia
Co-Investigator(s): Anis, Aslam H; Brissette, Suzanne; Bruneau, Julie; Marsh, David C; Nosyk, Bohdan P; Schechter, Martin T; Schütz, Christian G
Institution: St. Paul's Hospital, Vancouver
CIHR Institute: Neurosciences, Mental Health and Addiction
Program: Randomized Controlled Trials
Peer Review Committee: Randomized Controlled Trials - B (RSB)
Competition Year: 2008
Term: 3 yrs 0 mth
Abstract Summary

Inner city populations, particularly injection drug users, are at extremely high risk of many drug related harms including HIV, hepatitis C and overdose death. While some treatments exist, they are not optimal and people with the most severe cases of heroin addiction remain outside of the health care system. To improve the treatment of addiction, my colleagues and I are conducting innovative clinical trials that are testing whether medically prescribed heroin is a safe and effective treatment that improves on currently available therapies. We are also testing if pills can be used instead of injections and whether licensed medications can be used instead of heroin. We will give special attention to women and how they respond to the treatments we are testing. The ultimate goal of this research is to benefit both people with the most severe cases of heroin addiction as well as their communities.

Research Characteristics

This project includes the following research characteristics:

Cost Effectiveness
Budget Impact
Health Technology Assessment
Resource Utilization
Productivity Outcomes
Policy Evaluation
Health System Integration
Patient Reported Outcomes
Patient Engagement
Community Based
Regulatory Pathway
Ethics Focus
Comorbidity Focus
Social Determinants
Health Equity
Multicenter
Knowledge Translation Focus
Equity Considerations
Safety Focus
Quality of Life
Composite Endpoint
Vulnerable Populations
Study Justification

"testing whether medically prescribed heroin is a safe and effective treatment that improves on currently available therapies"

Novelty Statement

"The ultimate goal of this research is to benefit both people with the most severe cases of heroin addiction as well as their communities."

Methodology Innovation

double-blind randomized controlled trial comparing diacetylmorphine vs. hydromorphone for treatment-refractory opioid use disorder

Keywords
Maintenance Treatment Opioid Dependence Randomized Clinical Trial Therapeutic Use Of Narcotics