Study to Assess Longer-term Opioid Medication Effectiveness (SALOME)
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Purpose
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; heroin) in the treatment of chronic, multi-morbid opioid-dependent individuals who have not benefited sufficiently from conventional treatments, and if a switch to the oral equivalent of hydromorphone and diacetylmorphine is as effective as the injection form. The availability of an effective, licensed opioid medication such as hydromorphone, for substitution treatment of chronic, multi-morbid treatment-refractory opioid-dependent individuals, would be of immense impact locally and internationally. It could help to establish alternative treatment options where for non-medical reasons Heroin Assisted Treatment would not be acceptable. Thus, one result could be the expansion of treatment options for the most difficult to treat heroin dependent persons. This would also be an important step for secondary prevention of HIV and Hepatitis C as well as a better integration of those patients in other medical treatments. Switching from intravenous to oral application would also reduce a lot of potential risk factors (like overdose, seizures, infections, etc) and side effects associated with the injection route. Additionally it could make these treatments more feasible in normal treatment settings, like existing methadone services.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid Dependence Heroin Dependence |
Drug: Hydromorphone, Injectable Drug: Diacetylmorphine, injectable Drug: Hydromorphone, liquid oral Drug: Diacetylmorphine, liquid oral |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | SALOME: Multi-Centre, Double Blind Randomized Controlled Trial Comparing The Effectiveness Of Diacetylmorphine Vs. Hydromorphone For The Treatment Of Long-Term Injection Opioid Users Who Do Not Benefit From Available Therapies |
- Change in days of illicit heroin use from baseline. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]Use of illicit heroin at a time point is defined as the number of days of illicit ("street") heroin in the prior 30 days of the 6 month treatment period by means of self report.
| Estimated Enrollment: | 322 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Hydromorphone
Phase I: Injectable Hydromorphone is received for 6 months of the study. Phase II: At 6 months, participants are randomized to either: 1) stay on injectable hydromorphone; or 2) switch to oral hydromorphone, for another six months.
|
Drug: Hydromorphone, Injectable
Phase I: 3x daily, up to 500mg per day, for 6 months. Phase II: At 6 months, participants are randomized to either: 1) stay on injectable hydromorphone; 2) switch to oral hydromorphone, for another 6 months.
Drug: Hydromorphone, liquid oral
Study Phase II: After 6 months of receiving Hydromorphone injectable , participants will be randomized to stay on injectable hydromorphone or switch to oral hydromorphone, for another six months. Oral = experimental; injectable = active comparator
|
|
Active Comparator: Diacetylmorphine
Phase I: Injectable Diacetylmorphine is received for 6 months of the study. Phase II: At 6 months, participants are randomized to either: 1) stay on injectable Diacetylmorphine; or 2) switch to oral Diacetylmorphine, for another six months.
|
Drug: Diacetylmorphine, injectable
Phase I: 3x daily, up to 1,000mg per day, for 6 months. Phase II: At 6 months, participants are randomized to either: 1) stay on injectable diacetylmorphine; 2) switch to oral diacetylmorphine, for another 6 months.
Drug: Diacetylmorphine, liquid oral
Study Phase II: After 6 months of receiving Diacetylmorphine injectable, participants will be randomized to stay on injectable Diacetylmorphine or switch to oral Diacetylmorphine, for another six months. Oral = experimental; injectable = active comparator
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
General Inclusion Criteria:
- 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 Criteria:
- Pregnancy upon study entry
- Diagnosis of severe medical or psychiatric conditions contra-indicated for diacetylmorphine or hydromorphone treatment.
Contacts and Locations| Contact: Salima Jutha | salome.study@gmail.com |
| Canada, British Columbia | |
| SALOME Research Office | Recruiting |
| Vancouver, British Columbia, Canada, V6B 1C8 | |
| Contact: Kirsten Marchand salome.study@gmail.com | |
| Principal Investigator: Eugenia Oveido-Joekes, Ph.D | |
| Principal Investigator: | Eugenia Oveido-Joekes, Ph.D. | University of British Columbia |
| Principal Investigator: | Michael R Krausz, M.D. | University of British Columbia |
More Information
Additional Information:
Publications:
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01447212 History of Changes |
| Other Study ID Numbers: | H09-01455 |
| Study First Received: | October 4, 2011 |
| Last Updated: | August 28, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
Opioid Dependence Long-term Opioid Injectors Opioid Substitution Treatment |
Hydromorphone Diamorphine Diacetylmorphine |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Heroin Dependence Substance-Related Disorders Mental Disorders Heroin Hydromorphone Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on May 16, 2013