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Hydromorphone works as well as heroin-assisted drug addiction treatment
Liz Highleyman, 2017-05-16 09:50:00
Hydromorphone was as effective as pharmaceutical heroin for opioid
addiction treatment, but it was associated with fewer serious side effects,
according to results from the SALOME trial presented yesterday at the 25th Harm
Reduction International Conference (HR17) in Montreal.
These findings suggest that both hydromorphone and heroin should be
included among the treatment options for opioid dependence, allowing providers
to tailor treatment to the individual, said study co-investigator David Marsh of
Northern Ontario School of Medicine.
Methadone and buprenorphine are the
standard medications used for opioid substitution therapy, but they do not work
for everyone. Around 15% to 25% of people who inject heroin will not respond well
to methadone. European studies have found that diacetylmorphine – the active
ingredient in heroin – can be more effective for this population.
Heroin-assisted treatment has a long history in the UK and is offered in European countries including Denmark, Germany,
the Netherlands and Switzerland. Research has shown that it improves outcomes for selected patients, decreasing
illicit drug use and its associated social and health-related harms. No one
worldwide has ever died of an overdose in heroin-assisted treatment, Marsh
The NAOMI (North American Opiate Medication Initiative) study, a phase
3 randomised controlled trial conducted in Vancouver and Montreal, was the
first major North American study comparing injectable diacetylmorphine versus oral
methadone. As previously reported, participants who received heroin were more likely to stay on
treatment and to reduce illicit drug use and other illegal activities.
heroin remains illegal for this purpose in most countries. Hydromorphone (brand
name Dilaudid) is a semi-synthetic morphine
derivative that works similarly to heroin, but it is an approved painkiller and
is widely legally available for medical use.
The phase 3 SALOME (Study to Assess Long-term Opioid Medication
Effectiveness) trial, conducted at the Providence Health Crosstown Clinic in Vancouver's Downtown Eastside,
evaluated whether hydromorphone is as effective as diacetylmorphine for the
treatment of long-term opioid addiction.
The earlier NAOMI study included a small group of
participants who received injectable hydromorphone to validate
self-reports of on-going drug use, because unlike diacetylmorphine it can be
distinguished from illicit heroin on a urine test.
Some participants couldn't tell the difference between
hydromorphone and diacetylmorphine, prompting researchers to conduct a larger
study comparing these two drugs, Marsh said.
SALOME enrolled 202 participants between 2011 and 2013. About 70% were
men, the mean age was 44 years and a third were of aboriginal origin; 60% reported
being homeless or unstably housed.
The participants were long-term chronic street opioid users, with at
least a five-year history of heroin use (mean 15 years) and regular heroin or
other opioid injection during the past year. On average they had been on
methadone maintenance therapy for almost five years, but had been abstinent
from illicit drugs for just seven months, Marsh said.
Participants were randomly assigned to receive injectable
diacetylmorphine or hydromorphone up to three times a day for six months, self-administered
under the supervision of nurses at the clinic.
Nearly half of the hydromorphone recipients said they thought they were
getting diacetylmorphine or were unsure, while a third of diacetylmorphine
recipients thought they were getting hydromorphone or were unsure. Treatment
retention was high and similar in both groups, at about 80%.
The study showed that hydromorphone was non-inferior to diacetylmorphine
in reducing use of any illicit opioid, both in an intent-to-treat analysis
(5.50 vs 3.15 days of use) and a per-protocol analysis that excluded people who
did not complete treatment (4.08 vs 2.64 days of use). However, hydromorphone
did not quite match diacetylmorphine in reducing street heroin use specifically
in the intent-to-treat analysis.
Hydromorphone was statistically superior in decreasing positive urine
tests, Marsh reported. In an intent-to-treat analysis 21% of urine tests were
positive in the hydromorphone groups versus 30% in the diacetylmorphine group.
Hydromorphone recipients also reported fewer days of illegal activity and less
crack cocaine use. (Results were previously published in JAMA Psychiatry.)
Hydromorphone had a better overall adverse events profile than
diacetylmorphine. In both groups the most common drug-related serious adverse
event was opioid overdose, in all cases managed successfully on site. There
were three overdoses in the hydromorphone group compared to 11 in the
diacetylmorphine group. All 11 cases of seizures occurred in the diacetylmorphine
"Where possible, both diacetylmorphine and hydromorphone should be
incorporated into the addiction treatment repertoire for opioid dependence
refractory to existing therapies," the researchers concluded. "In
jurisdictions where diacetylmorphine is currently not available, hydromorphone
provides a safe, effective and licensed alternative."
"We should by no means take the results of this trial to assume
that heroin or hydromorphone would completely replace methadone," Marsh stressed.
any other health condition, we need to have multiple medications to be able to
tailor a treatment regimen that matches the needs of the individual at that
SALOME not only demonstrated the effectiveness of alternatives to methadone, they
also paved the way for heroin-assisted treatment in North America – an arduous
process that even involved a lawsuit against the
Canadian federal government.
SALOME participants have formed a lasting community that continues to advocate for ethical
research involving drug users and to fight the stigma surrounding heroin use,
whether in a clinical trial or on the streets.