ID: 222

Type of submission: Oral

Conference track: Research

Topics: Innovative Harm Reduction Programmes; Opioid Substitution Therapy Programmes

Presenting author: Eugenia Oviedo-Joekes

Presenting author biography:

Dr. Eugenia Oviedo-Joekes is an Associate Professor at the School of Population and Public Health (University of British Columbia). Her main research area is public health and addictions, with a focus on testing alternative approaches to expand and diversify treatments for vulnerable populations.

Non-inferiority of hydromorphone compared to diacetylmorphine for long-term opioid dependence: A randomized clinical trial

Eugenia Oviedo-Joekes, Daphne Guh, Suzanne Brissette, Kirsten Marchand, Scott MacDonald, Kurt Lock, Julie Foreman, Scott Harrison, David Marsh, Martin Schechter

Background: Diacetylmorphine, the active ingredient in heroin, has been shown to be an effective treatment for people with long-term opioid dependence who have not benefitted from available treatments. However, due to political and regulatory barriers, diacetylmorphine is not available in many settings including the U.S. and Canada. This limits the treatment options for the most vulnerable street opioid users. The present study aimed to test if injectable hydromorphone is non-inferior to injectable diacetylmorphine in reducing illicit heroin and opioid use in chronic injection opioid users after six months of treatment.

Methods: SALOME (Study to Assess Longer-term Opioid Medication Effectiveness) was a phase III, double-blind, non-inferiority trial. Between December 2011 and 2013, the study randomized 202 long-term street opioid injectors in Vancouver (Canada) who were not benefitting from available treatments. Participants were randomly assigned to receive injectable diacetylmorphine or hydromorphone treatment (up to three times daily) for six months in a supervised clinic.

Results: Non-inferiority of hydromorphone was conclusive in both ITT and PP analyses of total street opioid use and positive urinalyses, and on PP analysis of street heroin use. Only the difference between ITT groups on street heroin use did not exclude the margin. The most common related serious adverse events were opioid overdoses (n=14) and seizures (n=11), all successfully treated on site without hospitalization. There were 3 overdoses in the hydromorphone group compared to 11 in the diacetylmorphine group, in 41,027 and 44,424 treatment episodes respectively. All 11 seizures occurred in 4 participants in the diacetylmorphine group.

Conclusions: Where possible, both diacetylmorphine and hydromorphone should be incorporated into the addiction treatment repertoire for opioid dependence refractory to existing therapies. In jurisdictions where diacetylmorphine is currently not available, hydromorphone provides a safe, effective and licensed alternative.