Study to Assess Longer-term Opioid Medication Effectiveness (SALOME) - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Heroin

Drug Information available for: Hydromorphone hydrochloride Hydromorphone

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

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.


Enrollment:	202
Study Start Date:	December 2011
Study Completion Date:	February 2016
Primary Completion Date:	June 2014 (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

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

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Eligibility


Ages Eligible for Study:	19 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447212

Locations


Canada, British Columbia
SALOME Research Office
Vancouver, British Columbia, Canada, V6B 1C8

Sponsors and Collaborators

University of British Columbia

Canadian Institutes of Health Research (CIHR)

Providence HealthCare

Innerchange Charitable Society

Investigators


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:

SALOME webpage. This link exits the ClinicalTrials.gov site

Publications:

Oviedo-Joekes E, Brissette S, Marsh DC, Lauzon P, Guh D, Anis A, Schechter MT. Diacetylmorphine versus methadone for the treatment of opioid addiction. N Engl J Med. 2009 Aug 20;361(8):777-86. doi: 10.1056/NEJMoa0810635.

Oviedo-Joekes E, Guh D, Brissette S, Marsh DC, Nosyk B, Krausz M, Anis A, Schechter MT. Double-blind injectable hydromorphone versus diacetylmorphine for the treatment of opioid dependence: a pilot study. J Subst Abuse Treat. 2010 Jun;38(4):408-11. doi: 10.1016/j.jsat.2010.03.003. Epub 2010 Mar 31.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Oviedo-Joekes E, Marchand K, Lock K, MacDonald S, Guh D, Schechter MT. The SALOME study: recruitment experiences in a clinical trial offering injectable diacetylmorphine and hydromorphone for opioid dependency. Subst Abuse Treat Prev Policy. 2015 Jan 26;10:3. doi: 10.1186/1747-597X-10-3.


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:	June 5, 2016
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 Chemically-Induced Disorders Mental Disorders Analgesics, Opioid Hydromorphone	Heroin Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 23, 2016

Study to Assess Longer-term Opioid Medication Effectiveness (SALOME) (SALOME)