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A study published in the August 20, 2009 issue of The New England Journal of Medicine and reported in The New York Times may challenge our conception of how to best treat opioid addiction. The study, conducted in Canada and led by Dr. Martin Schechter, shows promising results for using the active ingredient in heroin, diacetylmorphine, to treat people addicted to opioids, who do not respond to methadone treatment. Currently no prescriptions can be written for heroin in the U.S. Heroin is included in Schedule I of the Controlled Substances Act based on its high potential for abuse, the lack of any accepted medical use in the U.S., and the lack of accepted safety for use of the drug under medical supervision. Research on the efficacy of heroin maintenance treatment in reducing opioid dependence may call the basis of that classification into question.
Participants in the study, all of who had previously been unsuccessful in methadone treatment programs, were assigned to either take oral methadone (n=111) or injectable diacetylmorphine (n=115). Another 25 subjects were given injectable hydromorphone (n=25) in order to verify the self-reported rates of heroin use through urine analysis. Both the participants and the investigators were aware of whether the assigned treatment was methadone or diacetylmorphine. The assignment of the injectable treatments, however, was double-blind. The injectables were administered under supervision, and methadone was dispensed at a pharmacy or clinic on a daily basis.
After one year of treatment, the patients receiving diacetylmorphine were more likely than those receiving methadone to have reduced rates of illegal activities including drug use (67% compared to 47.7%, p<.004), and to still be participating in the treatment program (87.8% compared to 54.1%, p<.001). The diacetylmorphine group also showed “greater improvements with respect to medical and psychiatric status, economic status, employment situation, and family and social relations.”
Interestingly, the investigators “observed similar outcomes” from the two injectables, but did not have enough power to compare the conditions. They note that if hydromorphone is as effective as diacetylmorphine, then it may be easier to employ as a treatment, avoiding the many hurdles associated with prescribing the active ingredient in heroin.
During the trial, diacetylmorphine was associated with a higher incidence of serious adverse events, raising questions about the safety of the drug. Twenty-four of the 29 serious adverse events that were related to a study drug, occurred in the diacetylmorphine group (most commonly seizures and overdoses). The investigators suggest that the drug should only be administered under close medical supervision, so the patient can be treated promptly in event of a seizure or overdose, as was the case in this study.
Based on the data, patients in both the methadone and the diacetylmorphine treatments improved. The more dramatic improvement in the diacetylmorphine group among these participants indicates that using this drug may be an effective treatment for patients who are unresponsive to methadone treatment, and who would otherwise, having exhausted their medical options, exit the healthcare system and, likely, wind up entering the criminal justice system.
Although the clinical evidence is the first of its kind gathered in North America, European researchers have previously found similar results with heroin maintenance programs, and some countries have applied those findings. According to Dr. Virginia Berridge’s editorial in the same issue of NEJM, doctors in Switzerland and the Netherlands have already begun prescribing heroin.
Berridge gives a thoughtful analysis of how attitudes about drugs and maintenance treatment depend on context: who the are people using them, the needs of the medical profession, whether the drug was first used as a “medical” drug or a “killer” drug, and how we define treatment and recovery. Berridge’s editorial is an informative companion to the diacetylmorphine and methadone comparison study, pointing out that policy on treating drug addiction often depends as much on the political and social context as it does on scientific evidence.
– Kelly Lowenberg