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

Comments

  1. David Marsh says:

    I welcome the chance to comment on a couple of points in the article which require clarification.

    First, the NAOMI study was approved by ethical review boards at three Canadian universities, the participating hospitals and others. Also all participants were clearly informed on multiple occasions prior to enrollment that the injection medication would not be continued beyond the study period but they would be offered the best available maintenance treatment in their communities (methadone and/or buprenorphine). In the Swiss experience over 70% of heroin assisted treatment patients choose to leave this treatment, predominantly for MMT. So transfer to methadone should not be presented as abandonment of care. Nor is it analogous to to a study of tapering patients off maintenance treatment completely as your article suggests.

    Second, all patients on methadone or injection medication had access to counseling services throughout the study. Your article implies that the methadone offered was inferior due to lack of counseling.

    Finally patient choice and involvement in research and care are very important which is why injection drug users and patients were actively involved in planning prior to and throughout the NAOMI study. While I appreciate your forum drawing attention to the report involving a small number of former NAOMI participants, I would have hoped for a more balanced presentation including views from a number of other perspectives.

    The real ethical question here is why an additional treatment which has been shown to be superior for a select group of high need patients, has not received funding and regulatory support from provincial and federal authorities.

    David Marsh MD CCSAM ASAM ABAM
    Clinical Lead, NAOMI study

  2. Once again, it appears that individuals with opioid dependencies/addictions are being devalued. Here, they are being treated much like laboratory rats. When their usefulness as test subjects is over they are discarded. Much more thought should have been put into what to do with these subjects if the heroin maintenance proved effective where other treatments have failed. If they thought that more structured methadone maintenance is a viable alternative that should have been the subject of the study.

  3. Ethical or not, hard to decide. Rather ban marijuana.

  4. Robert A Substance Counselor says:

    What is the goal of treatment? Do we offer medicated assisted treatment for opioid dependence as a means to stabilize an opioid dependent person in order to allow an opportunity for normality through counseling, training, and a desire to be more? While avoiding the high risk time consuming behavior associated with illegal procurement of controlled substances. It would appear that offering a debilitating substance as a control was and is without moral value.

  5. Thank you Dr. Marsh for your comments, which are accurate and well-grounded. We need to point out that our blog was about the patients and their own “paper,” not a scientific review of the NAOMI study, not a report on the Canadian government’s refusal to fund heroin maintenance for those who may benefit from it. Many of your comments are so sensible, and we hope that people in the United States, where patients also participate in clinical trials but are withdrawn from study medications at the end of the research, can forge bonds across the border on common issues relating to treatment for opioid addiction.

  6. Wow this is really an eye opening discussion. Thanks for shedding some light on this subject. I had no idea that such clinical trials were taking place. I got sober when I was 17 and I have been clean and sober for the past 8 years.

  7. I hope heroin maintenance becomes part of the Affordable Care Act one day. People would be surprised at the amount of tangible work that is accomplished under the influence of heavy duty opiates and marijuana. You might have a home because I was hard narcotics. Personally, I get tired of the stigma involved with the use of opiates. I think that some people are broken physically and mentally, so hard drug opiates are attractive. Unfortunately, most people want to break opiate addicts even further despite what the enormous potential some have to offer as people. Compromise in America usually means one side wins hugely and the other not as badly. I just try harder in the hope that people realize the prevailing attitudes against opiate users amount to prejudice and hatred. I wish people would rethink using needles to inject opiates because it can be damaging. However, diabetics get inject every single day and get along just fine. If I were most honest about it, America is filled with stupid and ignorant attitudes especially when it comes to a subject like hard drugs.

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