Heroin-Assisted Treatment Helps Some Patients

Dutch and Canadian researchers have found heroin-assisted treatment (HAT) to be more effective than methadone-maintenance therapy in improving the physiological health and functional outcomes of patients with chronic heroin addiction who have relapsed from previous courses of methadone or buprenorphine treatment.

HAT refers to a type of treatment program in which chronically heroin-addicted patients are given pharmaceutical-grade prescription heroin under the supervision of trained medical personnel. HAT is provided in a number of European countries including Switzerland, the Netherlands, and Germany.

At the annual meeting of the American Academy of Addiction Psychiatry held last December in Boca Raton, Fla., Wim van den Brink, M.D., Ph.D., presented findings from two randomized, open-label clinical trials on the effectiveness of HAT that he and his colleagues at the Amsterdam Institute for Addiction Research have conducted. He is the director of the institute and a professor of psychiatry and addiction at the Academic Medical Center at the University of Amsterdam. The results of the two studies were pooled and published in one article in the January 2005 Addiction.

Patients in the two studies had an average of 16 years of heroin addiction and 12 years of methadone treatment, had been refractory to past methadone treatment, and had a high level of physical, psychiatric, and social dysfunction. In one study, 174 patients with addiction to inhaled heroin were randomized to either the conventional methadone treatment alone or methadone plus medically prescribed heroin. In the other study, 375 patients were randomized to either the methadone treatment or methadone plus injectable heroin.

All patients received oral methadone at a dose of no more than 150 mg a day. Patients on inhaled or intravenous heroin were given heroin under medical supervision no more than three times a day at a dose of no more than 400 mg per administration and no more than 1,000 mg a day.

After pooling data from the two studies, the researchers found that 52 percent of patients receiving medically prescribed heroin plus methadone achieved clinical response at the end of one year's treatment. This was significantly higher than the 29 percent response rate in the group treated with methadone alone. Clinical response was based on a multidomain index that combined physical health, mental status, and social functioning assessments and was defined as 40 percent improvement on any of the three scales, with no serious deterioration. Patients receiving a medically supervised heroin regimen had a sharp drop in illicit heroin purchase and use. Meanwhile, the researchers observed no increased use of cocaine and other drugs. The average amount of medically supervised heroin requested by the study patients was found to be far below 1,000 mg a day, the maximum dose allowed by the protocol, van den Brink pointed out.

Additional analyses of the study data indicate that overall HAT plus methadone was also more cost-effective than methadone treatment to society, if the legal costs of prosecuting illegal heroin use were taken into consideration. He noted that clinical trials in Switzerland, Spain, the United Kingdom, and Germany similarly supported the effectiveness of HAT.

Recently, a Canadian study comparing HAT with conventional methadone treatment also generated positive outcome data similar to the European HAT studies. The first-year results of the North American Opiate Medication Initiative (NAOMI) study, released on October 17, 2008, showed that 88 percent of patients randomized to HAT remained in the treatment program after 12 months, which was significantly higher than the 54 percent retention rate in the methadone-maintenance treatment group. Patients' illicit heroin use and involvement in illegal activities dropped substantially, while their medical status improved. “The injectable treatment appears to be extremely safe,” the report concluded.

The study included 251 patients with chronic, treatment-refractory heroin addiction in Vancouver and Montreal who had failed other treatments at least twice. The patients were randomly assigned to either prescription heroin injection treatment or oral methadone therapy. The oral methadone therapy was optimized with a dose at least 50 percent higher than the community average. The injections were given for 12 months and gradually tapered off over three months. Patients were then transitioned to methadone, abstinence, or other treatment programs and are being followed for two additional years.

“We now have evidence to show that heroin-assisted therapy is a safe and effective treatment for people with chronic heroin addiction who have not benefited from previous treatments,” said Martin Schechter, M.D., Ph.D., the principal investigator of the NAOMI study and a professor and director at the School of Population and Public Health at the University of British Columbia.

Enrollment in the NAOMI study began in early 2005 and closed in spring 2007. By June 2008 all participants had completed treatment. All will be monitored for two more years. The study is funded by the Canadian Institutes of Health Research.

Van den Brink emphasized that “HAT is an effective option only if you have easily accessible and [high-quality] methadone and buprenorphine treatment programs.” The availability of adequate methadone and buprenorphine treatments in the United States lags behind that of Europe, he indicated. To implement HAT programs also requires “full acceptance of the harm reduction concept” by the medical community and the society beyond the goal of abstinence only, which may pose cultural challenges.

“Supervised heroin-assisted treatment is not a first-line treatment. It is the last resort,” said van den Brink.

An abstract of “Matching of Treatment-Resistant Heroin-Dependent Patients to Medical Prescription of Heroin or Oral Methadone Treatment: Results From Two Randomized Controlled Trials” is posted at<www3.interscience.wiley.com/journal/118739139/abstract>. Information about the NAOMI study and a report of results are posted at<www.naomistudy.ca>.▪