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Part 1—History of Federal and State Involvement in Narcotic Treatment

How Did Federal and State Agencies Become Involved in Narcotic Treatment Programs?

Treatment modalities for opioid addiction have changed over time with shifts in social and political images of opioid addicts. Opioid addiction emerged as a serious problem in the United States after the Civil War, when narcotic drugs were widely prescribed to alleviate acute and chronic discomfort and stress. During that period, the majority of opioid-addicted persons were middle- and upper-class women and war veterans who became addicted through the use of prescribed medication. Such iatrogenic addiction was regarded as an unfortunate medical condition, and sanatoria were established to house and treat addicted people. The chronic nature of opioid addiction was evident, however, as many of the people who entered sanatoria for a cure relapsed to addictive use after discharge.

By the end of the 19th century, the prevalence of opioid addiction in Civil War veterans and women decreased as these people died and doctors became more cautious in prescribing narcotics to their patients. At that time, opium smoking was popular among small groups of Americans but most community leaders regarded the use of opium to be socially irresponsible and immoral.

In the early 20th century, the incidence of addiction in urban areas increased. Young, impoverished European immigrants, crowded into urban tenements, became susceptible to addiction. The use of opium, heroin, and cocaine and the increased crime in poor urban areas became important concerns to social, religious, and political leaders.

After World War II, opioid addiction continued in urban areas, but shifted from European immigrants to African-American and Hispanic people who moved into northern industrial cities as European immigrants moved into suburban areas. Attitudes toward the addict changed from compassion and support for women and veterans who had become iatrogenically addicted to disdain and stigmatization of poor and minority addicts in inner-city ghettos.

The first national response to the changing image of the addict occurred as a legal act of Congress. The Harrison Narcotic Act of 1914 was passed by Congress to fulfill the U.S. obligations to uphold the international agreement of the 1912 Hague Convention. The Harrison Act was not originally written as a prohibition law, but as a means to regulate the manufacture, distribution, and prescription of opiates, coca, and their derivatives and to decrease opium trade with southeast Asia and China. The Act made it illegal to possess any of these drugs unless licensed by the Internal Revenue Bureau of the Treasury Department. All manufacturers, pharmacists, and physicians had to be licensed and keep records regarding narcotics. The Act allowed physicians to prescribe narcotics for "legitimate medical purposes" in the course of their "professional practice only." It did not permit the prescribing of narcotics for maintenance, because the U.S. Treasury Department did not view addiction as a disease and addicts were not seen as legitimate patients.

The position of the Treasury Department was upheld in 1919 by a Supreme Court ruling, which in effect outlawed opioid addiction maintenance treatment. This interpretation of the Harrison Act led to an era of strong narcotics regulation.

In later years, the incidence of addiction and crimes related to addiction rose dramatically in urban areas. The Federal Government responded between 1936 and 1938 by opening two U.S. Public Health Service hospitals for the treatment of addiction. The hospitals, located in Lexington, Kentucky, and Fort Worth, Texas, were the principal resources for addiction treatment in the United States until the 1960s.

Both the legal and medical professions in the United States were upset by the rise in heroin addiction and its associated social, criminal, and medical consequences. In 1956, the Joint Committee of the American Bar Association and the American Medical Association was formed to review the problem. The committee issued a report in 1958 that recommended the establishment of an outpatient clinic to prescribe narcotics on a controlled experimental basis. In 1963, President Kennedy's Advisory Commission on Narcotic and Drug Abuse also recommended that research be conducted to determine the effectiveness of dispensing narcotics in outpatient facilities.

The use of methadone for opioid maintenance treatment began in New York City in 1964 as part of research conducted by Drs. Vincent Dole and Marie Nyswander of The Rockefeller University. Because methadone presented distinct advantages over morphine as a drug for heroin detoxification (see "What is Methadone Treatment?"), Dole and Nyswander began using methadone in a controlled study. The study team proposed that heroin addiction may be a metabolic disease resulting from the repeated use of narcotics.

Successful patient outcomes from this study and many others in the following years led to the expansion of methadone treatment for heroin addiction as a major public health initiative. Legislative actions in the 1960s acknowledged the necessary role of a medical intervention toward solving the nation's narcotic addiction problem (see exhibit A). With program expansion came an array of administrative and programmatic problems, such as overcrowded program facilities and diversion of medication from patients to persons not enrolled in a program. Media attention to these problems fostered a negative public image of methadone treatment programs.

In the early 1970s White House staff under President Nixon commissioned the National Institute of Mental Health (NIMH), in collaboration with several other Federal offices, to provide policy and program recommendations for initiatives to respond to the increase in heroin addiction. At the same time White House staff invited comments from a nongovernmental advisory group of professionals in the field of substance abuse. The NIMH-led group recommended that methadone be further investigated and not approved as a treatment method. The non-Federal advisory group proposed a strategy to rapidly expand all forms of treatment including methadone treatment. In response to the policy recommendations, the President named Dr. Jerome Jaffe as the Director of the Special Action Office for Drug Abuse Prevention. One of the early goals of this office was to promulgate FDA regulations that would govern the use of methadone to treat opioid addiction.

In the late 1970s, the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA) jointly promulgated standards for methadone programs. These standards were developed to provide a means to regulate the safety and improve the effectiveness of methadone programs through a formal approval and monitoring process. The regulations created State Authorities (SAs) for the purpose of participating in the process of approving and evaluating programs. Yet, early regulations were criticized by practitioners as interfering in the practice of medicine, and both Federal and State regulations have been revised several times.

Today, there are nearly 1,000 FDA-approved narcotic treatment programs in 43 States, 3 territories, and the District of Columbia. Each year since 1988, from 32 to 45 new methadone treatment programs and 14 to 16 hospital-based detoxification programs have been approved. Recent changes in patient characteristics present new challenges for narcotic treatment providers. The high incidence of HIV infection among injecting drug users, the changing demographics of the addicted population, the rapidly developing problem of multiple-drug-resistant tuberculosis, the epidemic of sexually transmitted diseases in parts of the country, and the increase in multiple drug abuse place additional pressure on programs to offer comprehensive primary care and public health services to opioid-dependent individuals.

What Is Methadone Treatment?

Methadone treatment is one of the most widely used modes of treatment for opioid addiction. As designed by Drs. Dole and Nyswander, methadone is a medically safe and effective treatment. As a treatment for a chronic medical disorder, methadone treatment offers a long-term, sometimes permanent, replacement pharmacotherapy. Through use of this legally controlled medication, combined with counseling and other supportive services, many opioid addicts enrolled in methadone treatment programs are able to stop illegal opioid and other drug use and return to more stable, productive lives.

Methadone is a synthetic medication that was developed in Germany during World War II as a substitute painkiller when morphine was in short supply. Subsequent clinical research showed that the drug could be used effectively to treat opioid withdrawal syndrome by replacing morphine or heroin with methadone. Yet methadone differs from other narcotics; when properly prescribed it does not produce a euphoric or tranquilizing effect. Instead, it relieves the narcotic craving described by addicts. It is effective when administered orally, and because it is long-acting (24-36 hours), it can be taken once a day.

Methadone treatment has been used to treat opioid addiction in the United States since the mid-1960s. Despite extensive research documenting its effectiveness in reducing opioid use, decreasing criminal behavior, and improving health status, methadone treatment continues to be debated among medical and health care professionals, substance <R>abuse providers, public officials, and policy makers. Some criticize methadone treatment as merely a substitution therapy that does not end opioid addiction, while others contend that methadone treatment provides a valuable mechanism for addressing important public health issues such as preventing the spread of HIV infection among injecting drug users. Other critics are leery about the potential risk of diversion of narcotic medications by patients who are allowed to take the medication home, but supporters of methadone programs believe that close monitoring of patient compliance with program rules prevents medication diversion.

Medication Under Study for Narcotic Treatment

Given that methadone is only effective for a 24-36 hour period, ongoing research is examining the effects of a longer acting medication with similar properties to methadone. Clinicians believe that longer acting medications could have practical therapeutic advantages because patients would receive medication less frequently, and would need fewer, if any, take-home medications. Recent studies indicate that levo-alpha-acetylmethadol (LAAM) has these qualities.

LAAM is a synthetic opioid that, when ingested orally, has been found to suppress opioid withdrawal symptoms for up to 72 hours with minimal side effects (Greenstein et al. 1992). Interim Federal regulations approving the use of LAAM as a substitution therapy for opioid addiction became effective July 20, 1993.<R>(See appendix E.) A final regulation is currently under review by FDA. This approval applies to the Federal level only; availability of LAAM within a State will depend on State-level approvals as well.

What Is Interim Maintenance Treatment?

Interim maintenance treatment services should be viewed as a bridge to the comprehensive methadone treatment system. The January 6, 1993 amendments to the methadone regulations established two types of methadone treatment: comprehensive maintenance treatment and interim maintenance treatment. Interim maintenance treatment was formulated to assist in reducing the transmission of HIV disease by enabling comprehensive maintenance treatment programs to admit an individual, otherwise eligible for treatment, to interim maintenance treatment when the comprehensive maintenance treatment program is unable to admit or readmit the individual in comprehensive treatment within 14 days of seeking admission.

Under interim maintenance treatment, patients must receive appropriate medical services, HIV counseling, and urine screens in addition to methadone medication. At a minimum, interim maintenance treatment services must include an initial urine screen and at least two other urine screens taken from interim patients during the maximum 120 days permitted for interim treatment. Interim maintenance treatment programs are also advised by Federal agencies to perform more frequent drug testing to assist in assessing patient needs and priorities for transfer to comprehensive maintenance programs. After 120 days, a patient enrolled in interim maintenance treatment must be transferred to a comprehensive maintenance program if he or she is still in need of treatment.

The interim maintenance treatment regulations are applicable only to a public or nonprofit private narcotic treatment program that is approved by the State and FDA as a comprehensive methadone treatment program. The interim maintenance regulations permit a comprehensive maintenance treatment program to provide interim maintenance only with the approval of the chief public health officer in the State. In the process of reviewing a request for interim maintenance, it is appropriate for the chief public health officer to consult with the SA.

Interim maintenance treatment must be provided in a manner consistent with all applicable Federal and State laws. In addition, all requirements for comprehensive maintenance treatment, as described in this guide, apply to interim maintenance treatment, with the following exceptions:

• The narcotic drug is required to be administered daily under observation.
• Take-home medication is not allowed for any reason.
• The initial treatment plan and periodic treatment plan evaluation are not required.
• A primary counselor is not required to be assigned to a patient.
• Vocational and educational rehabilitation services are not required.
• Interim maintenance cannot be provided for longer than 120 days in any 12-month period.

Each interim maintenance treatment program must establish and follow reasonable criteria for transferring patients from interim maintenance to comprehensive maintenance treatment. These transfer criteria should be in writing and available for inspection. The criteria must include a preference for pregnant women in admitting patients to interim maintenance and in transferring patients from interim maintenance to comprehensive maintenance treatment. The interim maintenance program must notify the chief public health officer of the State when a patient begins interim treatment, when a patient leaves interim maintenance, and before the date of mandatory transfer to a comprehensive maintenance program. The program should document such notifications.

The interim maintenance regulation does not require programs to maintain a specific counselor-to-patient ratio. However, programs are required to provide a number of services, including referrals for comprehensive medical services, prenatal care, and HIV testing. Programs should ensure that sufficient counseling staff are available to provide these services and respond to patient emergency situations.

Interim maintenance treatment programs, as well as comprehensive maintenance and detoxification programs, must provide patients with counseling on preventing exposure to, and transmission of, HIV disease. Although HIV testing is not required by this regulation, HIV testing is an important element in reducing the risk of HIV transmission and must be made accessible to patients who request it. If a program does not provide HIV testing on site, then the program must refer patients who request testing to facilities where testing is available. Programs must ensure access to HIV testing through agreements with HIV testing facilities.

Last Updated 11-7-02