TORONTO (Reuters) -- The scene wouldn't be out of place in any other clinical trial. Patients receive measured doses of a drug prescribed by a doctor, and inject it in a sterile environment under the watchful eye of a nurse. They have access to counselors and health workers, complete personal health reports and follow up with the researchers six and twelve months after they finish their treatment.
The difference is that the setting is Vancouver, British Columbia's notorious Downtown Eastside, and these study participants are injecting heroin prescribed to them under an exemption to Canada's drug laws, given by Health Canada for the purpose of North America's first clinical trial studying medically prescribed heroin.
The North American Opiate Medication Initiative (NAOMI), funded by the Canadian Institutes of Health Research, is studying 251 people -- 192 in Vancouver, 59 in Montreal. The study participants have all been addicted to heroin for years, and haven't been able to get clean or manage their addictions with methadone, which blocks heroin cravings and prevents withdrawal symptoms, or other conventional treatments.
"The purpose of the NAOMI study is to look at people who are seriously addicted to heroin over a longer period time," said spokeswoman Julie Schneiderman. The researchers aim to determine if treatment with prescribed opiates can stabilize addiction in individuals who haven't benefited from other options.
Along with studying the effectiveness and retention rate of the prescribed opiate treatment, lead investigator Dr. Martin Schechter and his team are researching its cost-effectiveness. Earlier studies done in Europe have shown that prescribing heroin to difficult-to-treat addicts costs less than the health, judicial and law-enforcement resources used by untreated addicts, Schechter said.
About half of the individuals in the trial, which began in February 2005, received liquid methadone at the clinic once a day; the other half received heroin prescribed by a doctor, prepared by a pharmacist and self-injected under the supervision of a nurse. A subset of that group blindly received injectable hydromorphone, another opiate, instead of heroin.
The injection cohort could visit the clinic three times daily, but the average was 2.5 visits a day, Schneiderman said. The study worked on a rolling admission and departure schedule, but each participant was in for 15 months, the last three of which were spent transitioning into other treatment programs of their choice.
Those who wanted to leave the study were able to at any time, and they would be transitioned into other addiction programs, and those who wanted to go to other treatment options, like abstinence or methadone, were assisted, she said. Some of the individuals in the methadone cohort continued on that treatment after their 15 months ended.
For now, only a few people are left to finish the study, which ends its clinical portion next month. Similar studies are underway or planned in Germany, Spain and Australia, but the participants in the Canadian study cannot continue to receive injectable opiates once their 15 months are up -- to provide it at that point would be breaking the law, Schneiderman said.
Though the formal results are not yet available, the program's anecdotal results suggest that the prescribed opiate treatment has helped some addicts improve their lives. "I think that what we can see from the experience over the past few years is that the treatment appears to be very safe," Schechter said. "And we can see that one of the things we consider, which is the retention rate or how well people stay in treatment is very high -- it's been 85 percent at one year."
The research team has heard stories about women who no longer turned to prostitution for drug money, Schneiderman said. Some participants said they had stopped committing crimes in order to buy heroin, and others had found employment. "I know that Dr. Schechter has told stories of people who have thanked him and said.
"This is the first time that I've gotten up in the morning and the first thing that I didn't think about was where I was going to get my next fix,"' she said. The study provided a reminder that for addicts, that next fix is the focus of their entire day, she said; when that need is removed, they have time to focus on other ones, like employment, housing or relationships.
Prescribing heroin to addicts is not a new idea. Several prescribed morphine and heroin clinics ran in the United States from 1919 until 1923, when the government shut them down. The UK has been prescribing injectable heroin and methadone to opiate addicts for decades now, though evaluation of the programs is limited. And in 1972, an inquiry commission in Canada recommended a heroin prescription trial for addicts who hadn't been helped by conventional treatments.
A decade-old Swiss study of 1,000 long-term opiate addicts had a 69% retention rate, with no deaths and more than half of those who dropped out entering other treatment programs. The participants showed improvements in physical health and social indicators, their rate of arrests and illegal income generation went down substantially, and their rate of employment doubled over the 18-month period of the study. Another trial that began in the Netherlands in 1998 targeted people in methadone maintenance therapy -- widely available in that country -- who were still using illicit drugs, and the researchers saw improvements in the participants' physical and mental health, drug use and social indicators.
The risks and costs of drug use are high. There are about 1,000 drug-related overdose deaths a year in Canada, according to NAOMI. The United States has an estimated 600,000 opiate addicts, and Canada has 60,000 to 90,000. Untreated opiate addiction can lead to overdose, infectious diseases, loss of economic and social functioning, and criminal behavior -- all of which contribute major costs to the public health, health care, welfare and criminal justice systems. The costs of illicit drug use account for about 0.2% of Canada's gross national product, NAOMI said.
The NAOMI team applied to Health Canada for permission to continue the injectable prescribed heroin beyond the fifteen months of the study for five individuals they felt had benefited greatly from the treatment. Both Schechter and Schneiderman confirmed that the application had recently been rejected. The only reason given at this point was that Health Canada felt that the patients in questions had not yet exhausted all other treatment options.
But a reprieve given this week to another Vancouver addiction program might have implications for NAOMI as well, Schechter said. On Tuesday, the British Columbia Supreme Court decided that because addiction is an illness, shutting down Insite's facility for sterile, medically-supervised drug injection would be unconstitutional. The safe-injection facility's exemptions from Canada's drug laws were set to expire in June, and it was feared that the country's federal Health Minister would not provide the extension needed to keep Insite open.
Because Insite is a separate issue from NAOMI -- Insite users inject their own drugs, not prescribed narcotics -- It's too early to say what the impact of the court decision will be for medically prescribed heroin, Schechter said, though it will be examined. "It really calls into question federal policy around these types of harm-reduction activities," he said.
For those opposed to trials like NAOMI, Schechter points to the social and economic benefits that prescribed heroin and similar harm-reduction programs can provide. "The fact is that in the absence of this program, these people would be taking heroin several times a day," he said. The program's participants had an average duration of 20 years of heroin use, and their illegal drug use put them at risk for becoming infected with diseases like hepatitis and HIV. With NAOMI, these people are now exposed to health care professionals who can hopefully help them get better, he said.
"I think it's just unrealistic to think that without this study, they would not be using drugs," Schechter said. "So the question then becomes, how and where do you want them using them?"
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