October 17, 2008 12:45 ET
VANCOUVER, BRITISH COLUMBIA--(Marketwire - Oct. 17, 2008) - Researchers from the North American Opiate Medication Initiative (NAOMI Study) today released final data on the primary outcomes from the three-year randomized controlled clinical trial.
"Our data show remarkable retention rates and significant improvements in illicit heroin use, illegal activity and health for participants receiving injection assisted therapy, as well as those assigned to optimized methadone maintenance," says Dr. Martin Schechter, NAOMI's Principal Investigator, Centre for Health Evaluation and Outcome Sciences and Professor and Director, University of British Columbia School of Population and Public Health. "Prior to NAOMI, all of the study participants had not benefited from repeated standard addiction treatments. Society had basically written them off as impossible to treat."
The data, which was collected from 251 participants at sites in Vancouver and Montreal, demonstrate that a combination of optimized methadone maintenance therapy (MMT) and heroin assisted treatment (HAT) 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.
Key findings at the 12-month point of the treatment-phase of the study showed that HAT and MMT achieved high retention rates: 88 per cent and 54 per cent respectively. Illicit heroin use fell by almost 70 per cent. The proportion of participants involved in illegal activity fell by almost half from just over 70 per cent to approximately 36 per cent. Similarly, the number of days of illegal activity and the amount spent on drugs both decreased by almost half. In fact, participants once spending on average $1,500 per month on drugs reported spending between $300-$500 per month by the end of the treatment phase. Marked improvements were also seen in participants' medical status with scores improving by 27 per cent.
Of particular note amongst the findings, participants receiving hydromorphone (Dilaudid™) instead of heroin on a double-blind basis (neither they nor the researchers knew) did not distinguish this drug from heroin. Moreover, hydromorphone - an opiate licensed for the relief of pain - appeared to be equally effective as heroin, although the study was not designed to test this conclusively. According to the NAOMI Study Investigators, further research could help to confirm these observations, allowing hydromorphone assisted therapy to be made more widely available.
While a comprehensive health economics study is pending, researchers have already determined that the cost of continued treatment is much less than that of relapse.
"We now have evidence to show that heroin-assisted therapy is a safe and effective treatment for people with chronic heroin addiction who have not benefited from previous treatments. A combination of optimal therapies - as delivered in the NAOMI clinics - can attract those most severely addicted to heroin, keep them in treatment and more importantly, help to improve their social and medical conditions," explains Schechter.
A summary report of the findings and background information on the study are available at: www.naomistudy.ca.
Over the coming weeks, NAOMI Study researchers will be presenting results at the following conferences: Premier colloque francophone sur le traitement de la dependance aux opioides, (Opening Plenary, October 23) in Montreal, Quebec and the Canadian Society of Addiction Medicine Annual Scientific Meeting (Session IX-B, November 1) in Vancouver, B.C.
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 treatment phase of the study was completed in June 2008. Researchers will continue to gather and analyze data until NAOMI's expected closure date in mid-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.
Individuals were considered eligible for the NAOMI study if they:
- Had been addicted to heroin, dilaudid or another opiate for five years;
- Had been injecting heroin for the past year;
- Had tried addiction treatment twice in the past including methadone maintenance;
- Were 25 or older; and,
- In the case of the Vancouver site, were a member of the Downtown Vancouver community and had been for an extended period of time.
Funding provided by the Canadian Institutes of Health Research.
NAOMI StudyJulie Schneiderman(604) 806-8380orNAOMI StudyCandice Gartry(604) 806-8409orNAOMI Study MontrealNathalie Forgue, Communications OfficerCentre Hospitalier de l'Universite de Montreal(514) 801-5762 or (514) 890-8000, ext. 14342Email: firstname.lastname@example.orgWebsite: www.naomistudy.caorProvidence Health CareAlex VondetteCommunications Specialist(604) 806-9857 or Media Pager: (604) 252-4261
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