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

NCT01447212 | Completed Phase 3 DMC

• 1 other identifier: H09-01455
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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; 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.

Conditions

Opioid Dependence; Heroin Dependence

Keywords

Opioid Dependence; Long-term Opioid Injectors; Opioid Substitution Treatment; Hydromorphone; Diamorphine; Diacetylmorphine

Outcome Measures

Primary Outcomes (1)

• Change in days of illicit heroin use from baseline.

  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.

  baseline and 6 months

Study Arms (2)

Hydromorphone

EXPERIMENTAL

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; Drug: Hydromorphone, liquid oral

Diacetylmorphine

ACTIVE COMPARATOR

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; Drug: Diacetylmorphine, liquid oral

Interventions

Hydromorphone, Injectable DRUG

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.

Hydromorphone

Diacetylmorphine, injectable DRUG

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.

Diacetylmorphine

Hydromorphone, liquid oral DRUG

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

Hydromorphone

Diacetylmorphine, liquid oral DRUG

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

Diacetylmorphine

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy upon study entry
• Diagnosis of severe medical or psychiatric conditions contra-indicated for diacetylmorphine or hydromorphone treatment.

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Providence Healthcare: collaborator
• Innerchange Charitable Society: collaborator

Study Sites (1)

SALOME Research Office

Vancouver, British Columbia, V6B 1C8, Canada

Location

Related Publications (5)

• 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.

  PMID: 19692689 BACKGROUND

• 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.

  PMID: 20359843 BACKGROUND

• Palis H, Marchand K, Guh D, Brissette S, Lock K, MacDonald S, Harrison S, Anis AH, Krausz M, Marsh DC, Schechter MT, Oviedo-Joekes E. Men's and women's response to treatment and perceptions of outcomes in a randomized controlled trial of injectable opioid assisted treatment for severe opioid use disorder. Subst Abuse Treat Prev Policy. 2017 May 19;12(1):25. doi: 10.1186/s13011-017-0110-9.

  PMID: 28526048 DERIVED

• Oviedo-Joekes E, Guh D, Brissette S, Marchand K, MacDonald S, Lock K, Harrison S, Janmohamed A, Anis AH, Krausz M, Marsh DC, Schechter MT. Hydromorphone Compared With Diacetylmorphine for Long-term Opioid Dependence: A Randomized Clinical Trial. JAMA Psychiatry. 2016 May 1;73(5):447-55. doi: 10.1001/jamapsychiatry.2016.0109.

  PMID: 27049826 DERIVED

• 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.

  PMID: 25619263 DERIVED

Related Links

• SALOME webpage.

MeSH Terms

Conditions

Opioid-Related Disorders; Heroin Dependence

Interventions

Hydromorphone; Injections; Heroin; Fluid Therapy

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Eugenia Oveido-Joekes, Ph.D.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Michael R Krausz, M.D.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 6, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: February 1, 2016
• Last Updated: June 7, 2016

Record last verified: 2016-06

Locations

CA (1)