The NAOMI Study: After a Year on Heroin Maintenance, Is it Ethical to Terminate?

A Canadian study that started in 2005 comparing heroin maintenance with methadone maintenance has given rise to a protest from the patients used as guinea pigs.   The patients protesting were actual subjects, clinical trials participants who were injected on a daily basis with heroin for a year. They had already failed methadone maintenance treatment twice. At the end of the year, however, the study was over and after a three-month detox, they were given a choice of methadone or buprenorphine.

Last year, 44 of these subjects formed a group called the North American Opiate Medication Initiative (NAOMI) Patients Association (NPA), and started comparing  notes on how they did after being taken off heroin. In a report released in March full of bittersweet reminiscences of a year on heroin and some scathing comments on how they were treated in the trial (10 minutes to inject, and if they were late, they missed the appointment), and how they survived the years following, NPA members detail their experience, some managing to get clean, some cycling in and out of drug use.

The NAOMI study, published in 2009 in The New England Journal of Medicine, concluded that heroin maintenance was effective. The findings had little effect in the United States since heroin is Schedule I and not used as a treatment medication here.

But the study publication contributed to the formation of the NPA, with patients questioning why the trial would be shut down. In other countries where such trials were done, patients continued to receive heroin. Although NAOMI researchers asked the Canadian government to allow the people who were given heroin to stay on it for compassionate reasons, the government, which runs health care, refused in 2007.

There are some serious questions posed by the NPA about ethics: for example, because people wanted heroin, they signed up for the trial. Under these circumstances, can informed consent really be given? In addition, if something works, can you take it away? One of the participants quoted in the NPA report put it succinctly: “They’re experimenting with a drug for cancer and it starts working. I mean, what are they, what are you going to do? Oh no. You can’t have it anymore.”

Proponents of medicinal injectable heroin in Canada think that it’s better at keeping patients in treatment than methadone maintenance, for people who have relapsed from methadone maintenance at least twice before.

There are some flaws to this argument, however. First of all, methadone maintenance in Canada isn’t as regulated as it is in the United States, with counseling requirements. Another flaw is that 75 percent of the NAOMI patients on heroin were unemployed; that is not the case with OTP patients in the United States. In addition, the cost of treatment with heroin in the NAOMI study was $14,891 per patient a year, because of the cost of daily injection, compared to $3,192 for methadone maintenance. And finally, while the heroin maintenance group did have better retention in NAOMI than the methadone group, the dose of the methadone may have been too low; the average dose was 96 milligrams.

Can it happen here? Well, not exactly. But in a large-scale, short-term trial, tapering the buprenorphine dosage of opioid-dependent patients was a self-fulfilling disaster. More than nine out of ten patients relapsed in this trial—more than even the principal investigator had expected. Yes, everyone had expected dismal results. Yet the trial, funded by the National Institute on Drug Abuse, went ahead with that design because that is the way most physicians were using the medication for patients dependent on prescription opioids—as a detox drug. Let’s see if NIDA’s Prescription Opioid Addiction Treatment Study (POATS), as the buprenorphine study was called, leads to its own patient association.

For the NPA report, go to http://drugpolicy.ca/wp-content/uploads/2012/03/NPAreportMarch5-12.pdf