The North American Opiate Medication Initiative (Naomi) is the first trial of its kind in North America, and therefore the first on the continent to show that heroin-assisted therapy - providing chronic heroin addicts with controlled dosages of the drug in a medical setting - can help chronic addicts when other treatments like methadone therapy or abstinence programmes haven't.
The trial's final results, released this week, showed that the therapy helped reduce illegal drug use and related crimes. Similar trials in Europe have already shown that treatment with prescribed heroin improved health, decreased illegal drug use, and decreased health costs for chronic addicts, as well as showing that the treatment generally saved more money than it cost.
"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," said Dr Martin Schechter, the study's principal investigator, in a statement.
The clinical trial and its results are part of a wider debate about the role of harm reduction in fighting addiction. Those opposed say the focus should be on getting addicts to stop using heroin, not providing them access to the drug. Supporters of initiatives like heroin-assisted treatment (Hat) argue that harm reduction measures help reduce the social and economic burden of addiction, both for addicts themselves and for society at large. Those burdens include crime, unemployment and diseases like HIV and Hepatitis C.
Cost of addiction 'substantial'
The costs of heroin addiction are substantial. Canada has an estimated 60 000 to 90 000 opiate addicts; a 2006 study from the Centre for Addiction and Mental Health in Toronto found that illegal drug use costs Canadians $8.2 billion annually. In the United States, the number of opiate addicts is more than 1 million, according to the National Institute for Drug Abuse, and is on the rise.
Heroin-assisted treatment is aimed at the most serious cases of addiction - people who have not been helped by previous treatments and are chronic heroin users. These people tend to be socially and economically isolated. The Naomi study defined chronic addicts as people with a documented drug addiction spanning at least five years, and frequent heroin use for at least one year prior to entering the study.
European trials have studied the effectiveness of Hat, and found that it improved health status, increased employment, decreased illicit drug use and reduced criminal activity in chronic opiate addicts. Hat also puts chronic addicts, who are often socially and economically isolated, into an environment where they can receive medical care, counselling, social assistance and employment training that they otherwise couldn't access.
The Naomi study, funded by the Canadian Institutes of Health Research, found that a combination of methadone maintenance therapy and heroin-assisted therapy was able to retain the hardest-to-treat addicts in their respective communities, and created positive outcomes in those patients where other treatments had failed.
What the study showed
At the study's 12-month point, the retention rate for Hat was 88%, with a 54% rate for the methadone therapy. Use of illegal heroin in the study participants was down nearly 70%, and medical scores went up by 27%. The proportion of those engaging in illegal activity fell nearly half to 36%, as did the number of days of illegal activity and the amount spent on drugs.
"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," Schechter said. "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."
Notably, participants who took morphine instead of heroin in the double-blind study couldn't distinguish it from heroin, and the morphine appeared to be just as effective as the illegal drug. After a year in the study, participants who still required treatment were referred to a methadone maintenance programme or other treatment of their choosing. Nobody in the study received injectable medication, whether heroin or methadone, for longer than 15 months.
The trial's researchers say that heroin legalisation is not their goal. Rather, the aim was to gather scientific evidence about the usefulness of prescribed heroin as a treatment for chronic addicts who have been helped by nothing else.
Further economic analysis of the study is in the future, but the early results show that Hat can reduce the costs of addiction, the researchers said. The results on methadone therapy as a treatment option are worth further examination, they said. The study's treatment phase ended in June of this year, and its final closure date is projected for mid-2009, when a formal assessment of the cost-effectiveness of Hat will be made available. – (Reuters Health, October 2008)