Status:
COMPLETED
Study to Assess Longer-term Opioid Medication Effectiveness (SALOME)
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Providence Healthcare
Conditions:
Opioid Dependence
Heroin Dependence
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
The purpose of this study, SALOME, is to determine if 1) the closely supervised provision of injectable, hydromorphone (HDM; trade name Dilaudid™) is as effective as injectable diacetylmorphine (DAM; ...
Detailed Description
SALOME is two-stage single centre (Vancouver) phase III, randomized, double blind controlled trial involving a total of 202 individuals with chronic opioid-dependence who are not benefiting currently ...
Eligibility Criteria
Inclusion
- General
- Regular use of opioids for five years
- Injecting opioids in the past year
- Two attempts at treatment including one methadone (or other substitution)
- Must be a legal adult
- Struggling with drug related problems
- General
Exclusion
- Pregnancy upon study entry
- Diagnosis of severe medical or psychiatric conditions contra-indicated for diacetylmorphine or hydromorphone treatment.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT01447212
Start Date
December 1 2011
End Date
February 1 2016
Last Update
June 7 2016
Active Locations (1)
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1
SALOME Research Office
Vancouver, British Columbia, Canada, V6B 1C8