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Results of North America's
First Heroin Study (NAOMI)

Vancouver, August 20, 2009 - Published in the August 20th issue of the New England Journal of Medicine (NEJM), results of North America’s first heroin-assisted treatment study (North American Opiate Medication Initiative - NAOMI Study) confirm again that supervised prescribed heroin is a safe and effective treatment for people with chronic heroin addiction who have not benefited from previous treatments.

“Prior to NAOMI, all of the study participants had not benefited from repeated standard addiction treatments for their addiction treatment. Society had basically written them off as impossible to treat”, says Dr. Martin Schechter, NAOMI’s Principal Study Investigator, Centre for Health Evaluation and Outcome Sciences and Professor and Director, University of British Columbia School of Population and Public Health. ''Publication of the study results by such a prestigious peer-reviewed journal supports once again our conclusions on the urgent necessity of attracting those most severely heroin-dependent individuals, as the lack of alternative pharmacological treatments for opioid addiction poses a significant challenge to addiction treatment in polydrug users'', adds Dr. Eugenia Oviedo-Joekes, principal author of the NEJM article, Centre for Health Evaluation and Outcome Sciences and Professor, University of British Columbia School of Population and Public Health.

The data, which was collected from 251 participants at sites in Vancouver and Montreal, demonstrate that diacetylmorphine (DAM), administered under medical supervision, offered additional benefits over and above optimized methadone maintenance therapy (MMT) alone for patients with opioid addiction who are refractory to treatment. Opioid dependence is a chronic, relapsing disease estimated to affect more than one million individuals in North America. Studies in Europe have demonstrated that DAM, can be an effective treatment for such individuals.

Key Findings
Key findings at the 12-month point of the treatment-phase of the study had showed that the DAM group achieved a higher rate of retention than MMT. HAT and MMT achieved high retention rates during treatment: 88 per cent and 54 per cent respectively. The amount spent on drugs both decreased by almost half. In fact, participants once spending on average $1,200 USD per month on drugs reported spending between $320-$400 USD per month by the end of the treatment phase. For the outcome of a reduction in illicit-drug use or other illegal activities, 67.0% of the patients in the diacetylmorphine group were classified as having a response, as compared with 47.7% of patients in the methadone group. During the study, the DAM group improved significantly in six of the seven remaining evaluated areas: medical and psychiatric status, employment satisfaction, and family and social relations. The MMT group scores improved significantly in the economic and employment satisfaction composite scores. After adjusting for baseline scores, the DAM group scores improved significantly more than the

MMT group in the drug, psychiatric status, employment satisfaction, and family relations composite scores.

“Heroin-assisted therapy is a safe and effective treatment for people with chronic heroin addiction. It can attract and retain the most difficult-to-reach and the hardest-to-treat individuals who have not been well served by the existing treatment system” explains Dr Suzanne Brissette, Head, Addiction Medicine Department, Centre hospitalier de l'Université de Montréal, and Professor, Université de Montréal, and head investigator, NAOMI Study, Montreal.

Background
The NAOMI Study tested whether heroin-assisted therapy or methadone therapy is better for improving the health and quality of life of long-time opiate users. Eligible participants were randomly assigned to receive a 12-15-month course of medically prescribed injection opioids (heroin or hydromorphone) or oral methadone therapies. Following a slow, but steady recruitment of volunteers who met the study’s rigorous inclusion criteria, NAOMI fully enrolled 251 participants (192 in Vancouver and 59 in Montreal) by March of 2007. The Montreal clinic was operated in collaboration with the Centre de recherche et d’aide aux narcomanes (CRAN).

The treatment phase of the study was completed in June 2008. Researchers will continue to gather and analyze data until the end of 2009. Funded by the Canadian Institutes of Health Research, and approved by Health Canada, NAOMI enrolled and treated participants in Vancouver and Montreal since 2005.

Background information on the study is available here.