Study to Assess Longer-term Opioid Medication Effectiveness (SALOME) (SALOME)
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ClinicalTrials.gov Identifier: NCT01447212 |
Recruitment Status :
Completed
First Posted : October 6, 2011
Last Update Posted : June 7, 2016
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Condition or disease | Intervention/treatment | Phase |
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Opioid Dependence Heroin Dependence | Drug: Hydromorphone, Injectable Drug: Diacetylmorphine, injectable Drug: Hydromorphone, liquid oral Drug: Diacetylmorphine, liquid oral | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 202 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | December 2011 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | February 2016 |

Arm | Intervention/treatment |
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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.
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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.
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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 |
- Change in days of illicit heroin use from baseline. [ Time Frame: baseline and 6 months ]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.

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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447212
Canada, British Columbia | |
SALOME Research Office | |
Vancouver, British Columbia, Canada, V6B 1C8 |
Principal Investigator: | Eugenia Oveido-Joekes, Ph.D. | University of British Columbia | |
Principal Investigator: | Michael R Krausz, M.D. | University of British Columbia |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT01447212 |
Other Study ID Numbers: |
H09-01455 |
First Posted: | October 6, 2011 Key Record Dates |
Last Update Posted: | June 7, 2016 |
Last Verified: | June 2016 |
Opioid Dependence Long-term Opioid Injectors Opioid Substitution Treatment |
Hydromorphone Diamorphine Diacetylmorphine |
Opioid-Related Disorders Heroin Dependence Narcotic-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Hydromorphone Heroin |
Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |