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Hydromorphone as Effective as Pharmaceutical Heroin for Managing Opioid Dependence


Hydromorphone and pharmaceutical-grade heroin (diacetylmorphine) are both equally effective for the management of chronic heroin addiction among people who have not previously benefitted from medication-assisted treatment using methadone or buprenorphine, according to results from the SALOME study published in the April 6 online edition of JAMA Psychiatry.

Eugenia Oviedo-Joekes from St. Paul’s Hospital in Vancouver, Canada, and colleagues conducted theStudy to Assess Longer-term Opioid Medication Effectiveness (SALOME; NCT01447212) to evaluate whether injectable hydromorphone hydrochloride works as well as injectable diacetylmorphine hydrochloride in reducing illicit heroin use among chronic injection drug users. SALOME is a follow-up to the North American Opiate Medication Initiative(NAOMI), the first North American trial of prescription heroin for managing addiction.

Supervised administration of diacetylmorphine -- the active ingredient in heroin -- is known to be effective for the treatment of severe opioid use disorder, the researchers noted as background. However, due to political and regulatory barriers, it is not available in most countries, which limits options for long-term opioid injectors who do not benefit from available treatments such as methadone or buprenorphine (Suboxone). Prescription heroin is available in some European countries but not in the U.S. or Canada. If equally effective, injectable hydromorphone -- a widely licensed pain medication-- could offer another alternative.

This Phase 3 double-blind non-inferiority trial included 202 long-term street opioid injectors in Vancouver recruited between December 2011 and December 2013. About 70% were men and the mean age was 44 years. They had been injecting heroin for an average of 15 years and had tried methadone treatment without success.

Participants were randomly assigned to receive injectable diacetylmorphine or hydromorphone up to 3 times daily for 6 months. Medication was administered at Providence Health Care'sCrosstown Clinic under the supervision of an interdisciplinary team of physicians, nurses, social workers, and counselors.

Outcomes were self-reported number of days using street-acquired heroin or other street opioids in the past month and the proportion of heroin-positive urine tests.


  • Treatment retention was high (>80%) in both groups at 6 months.
  • Participants receiving either hydromorphone or diacetylmorphinereported using street-acquired heroin or other opioids less often -- 3-5 days per month on average, compared to almost daily use prior to enrollment.
  • Hydromorphone was shown to be non-inferior to diacetylmorphine for reducing street heroin use in a per-protocol analysis (-1.44 days; 90% CI -3.22 to +0.27), though not in an intention-to-treat analysis (-2.34 days; 90% CI -4.14 to +0.52).
  • Hydromorphone was non-inferior to diacetylmorphine for reducing use of any street-acquired opioids in both a per-protocol analysis (-0.15 days; 90% CI -2.09 to +1.76) and an intention-to-treat analysis (-0.85 days; 90% CI -2.97 to +1.25).
  • Non-inferiority of hydromorphone was also confirmed by urinalysis in per protocol (+0.13; 90% CI 0.02-0.24) and intention-to-treat (+0.09; 90% CI -0.02 to +0.19) analyses.
  • Participants also reported a significant reduction in illegal activities.
  • There were 5 serious adverse events in the hydromorphone group and 24 in the diacetylmorphine group that were considered to be related to the injection medication.
  • Most of these adverse events (25 out of 29) were seizures and overdoses.

"Taken together, these results suggest that injectable hydromorphone is as effective as injectable diacetylmorphine for long-term injection street opioid users not currently benefiting from available treatments," the study authors concluded. "In jurisdictions where diacetylmorphine is currently not available or for patients in whom it is contraindicated or unsuccessful, hydromorphone could be offered as an alternative."

Overall, there were fewer treatment-related adverse events and serious adverse events in the hydromorphone group compared with the diacetylmorphine group, they noted in their discussion. There were no seizures in the hydromorphone group and 4 in the diacetylmorphine group. There were also significantly fewer reports of drowsiness and overdoses among people using hydromorphone.

"Providing injectable opioids in specialized clinics under supervision ensures safety of both the patients and the community, and the provision of comprehensive care," Oviedo-Joekes stated in a University of British Columbia press release. The 14 overdoses and 11 seizures seen in the study were all successfully managed in the clinic, but could have been fatal if they had occurred on the street.

The ongoing epidemic of opioid overdose in the U.S. resulted in 28 647 deaths in 2014 -- almost as many deaths as caused by motor vehicle crashes,Richard Schottenfeld and Stephanie O’Malley from Yale School of Medicine noted in an accompanying editorial. In addition to the epidemic of non-medical prescription opioid use and overdose, heroin use and overdose have also increased over the past 15 years, with the largest increases in groups with historically lower rates, including women, white individuals, and people with higher incomes and private insurance.

"Despite the severe adverse consequences of opioid use disorder and the existence of effective treatments that substantially reduce the risk of these consequences, worldwide only a small proportion of people with opioid use disorder receive effective treatment," Schottenfeld and O’Malleywrote. SALOME and related studies "support the critical public health importance of expanding access and reducing barriers to evidence-based, medication-assisted treatments for opioid use disorder and improving treatment retention and treatment effectiveness for patients who do not benefit optimally from existing treatments."



E Oviedo-Joekes, D Guh, S Brissette, MT Schechter, et al. Hydromorphone Compared With Diacetylmorphine for Long-term Opioid Dependence: A Randomized Clinical Trial. JAMA Psychiatry. April 6, 2016 (online ahead of print).

RS Schottenfeld and SS O'Malley. Meeting the Growing Need for Heroin Addiction Treatment (commentary). JAMA Psychiatry. April 6, 2016 (online ahead of print).

Other Source

University of British Columbia. Results of World’s First Study on New Treatment for Heroin Addiction. Press release. April 6, 2016.