Methadone Maintenance in Primary Care

In their excellent review of pharmacologic treatment of heroin dependence, O’Connor and Fiellin (1) highlight the progress being made toward reintegrating addiction treatment into medical care settings. The separation of the addiction treatment system from mainstream medicine has limited physician knowledge about addictions and has isolated and stigmatized the system itself. One response to this separation is "medical maintenance," the treatment of stabilized methadone recipients in physician office-based practices. The authors assert that such programs will require regulatory changes to become feasible, yet recent progress has been made toward moving such programs into the mainstream. Previously, all medical maintenance programs were approved as experimental programs using the U.S. Food and Drug Administration (FDA) investigational new drug (IND) mechanism. In contrast, our new medical maintenance program in Seattle, Washington, has been granted program-wide exemptions from key FDA regulations, making medical maintenance possible without the IND mechanism. A recent letter from the leaders of the FDA and the Center for Substance Abuse Treatment, citing the Seattle program and a similar program in Connecticut, has made it clear that applications for such program-wide exemptions will be favorably considered. Given this federal leadership, and the precedent set by these new programs, medical maintenance is moving beyond the experimental phase and toward becoming an integral part of the continuum of care for heroin-dependent patients. It is now up to methadone treatment programs, physicians, and state methadone authorities to replicate these programs, allowing patients more flexibility in their care and increasing access to treatment. The generalist physicians in our program have found their practices to be enhanced as a result of their participation. Encountering patients who are addressing such a powerful addiction is humbling and inspiring, and having effective pharmacologic tools to assist these patients is highly rewarding.

Medical treatment of heroin addiction with methadone and other pharmacotherapies has important benefits for individuals and society. However, regulatory policies have separated this treatment from the medical care system, limiting access to care and contributing to the social stigma of even effective addiction pharmacotherapy. Increasing problems caused by heroin addiction have added urgency to the search for policies and programs that improve the access to and quality of opiate addiction treatment. Recent initiatives aiming to reintegrate methadone maintenance and other addiction pharmacotherapies into medical practice may promote both expanded treatment capacity and increased physician expertise in addiction medicine. These initiatives include changes in federal oversight of the opiate addiction treatment system, the approval of physician officebased methadone maintenance programs for stabilized patients, and federal legislation that could enable physicians to treat opiate addiction with new medications in regular medical practice.

Background: Methadone is effective treatment for opioid addiction, but regulations restrict its use. Methadone medical maintenance treats stabilized methadone patients in a medical setting, but only experimental programs have been studied. Objective: To evaluate the implementation of the first methadone medical maintenance program established outside a reseach setting. Design: One-year program evaluation. Setting: A public hospital and a community opioid treatment program. Participants: Methadone patients with >1 year of clinical stability. Eleven generalist physicians and 4 hospital pharmacists. Interventions: Regulatory exemptions were requested. Physicians and pharmacists were trained. Patients were transferred to the medical setting and permitted 1-month supplies of methadone. Measurements: Patient eligibility and willingness to enroll, treatment retention, urine toxicology results, change in addiction severity and functional status, medical services provided, patient and physician satisfaction, and physician attitudes toward methadone maintenance. Results: Regulatory exemptions were obtained after a 14-month process, and the program was cited in federal policy as acceptable for widespread implementation. Forty-nine of 684 patients (7.2%) met stability criteria, and 30 enrolled. Twenty-eight were retained for 1 year, and 2 transferred to other programs. Two patients had opioid-positive urine tests and were managed in the medical setting. Previously unmet medical needs were addressed, and the Addiction Severity Index (ASI) medical composite score improved over time (P=.02). Patient and physician satisfaction were high, and physician attitudes toward methadone maintenance treatment became more positive (P=.007). Conclusions: Methadone medical maintenance is complex to arrange but feasible outside a research setting, and can result in good clinical outcomes.

No abstract available.