Narcotics research, rehabilitation, and treatment. Hearings, Ninety ...

394ranging from chronic hospitalization through residential })rograms, tooutpatient ])sychotherapeutic efforts. The time, the manpower, andthe money required in all of these approaches have resulted in onlylimited success, making a successful chemical therapeutic agent anattractive alternative.This has resulted in a search for a medication that would do thefollowing: Block the euphoric effect of heroin for addicts, preventwithdrawal symptoms, be nonaddictive, be effective orally, be longacting, be free from toxic effects, and compatible with normal performanceand reasonable behavior. The addict would have to be freedof his craving or hunger for heroin.Methadone, as you know, is currently under study for the maintenancetreatment of narcotic addiction. It has been an effective analgesicsince it was synthesized at the end of World War II. Although'for more than a decade it has been known that low oral doses ofmethadone would allay withdrawal symptoms, it was not until 1963that it first was observed that large oral doses could block the euphoriceffects of even high doses or other opiates or synthetic narcotics. Thus,the current widespread interest in methadone for the maintenancetreatment for heroin addicts.Methadone is a marketed drug that has been approved through thenew drug procedures of the Food and Drug Administration, for thi*eespecific uses: As an analgesic, an antitussive, and for treatment ofwithdrawal symptoms in heroin addiction. The last refers to the shorttermtreatment of the acute symptoms resulting from the withdrawalof heroin from those who have become physiologically dej^endent.Maintenance treatment of heroin addiction with methadone isinvestigational because substantial evidence of its safety and effectivenessfor this use is not yet available. The law defuies "substantialevidence" as meaning evidence consisting of adequate and wellcontrolledinvestigations, including clinical investigations, by expertsqualified by scientific training and experience to evaluate the effectivenessof the drug. Although there are studies which suggest thatmethadone maintenance may be effective for some heroin addictsover a period of at least months, and perhaps even a few years, wehave no good body of data or well-controlled studies that meet therequired criteria.We are only now beginnmg to obtain the kmd of mformation whichmay eventually permit us to define the place of this drug in thetreatment of heroin addiction.Because it was available on prescription, the use of methadone formaintenence therapy became quite widespread following the earlyreports of success by Drs. Dole and Nyswander.In order to collect the type of scientific data needed to support approvalof a new use of a drug, it was necessary that the maintenanceprograms follow protocols, protocols which include recordkeeping,that could in fact yield such data. Investigational studies of methadonepresent problems not encountered in studies with other types of drugsbecause it is an addicting narcotic with a proven capacity for abuse.Therefore, to protect the community from the hazards of diversionand abuse, and to assure the development of valid data, guidelinesfor methadone maintenance studies were developed through the cooperationof the National Institute of Mental Health, the Bureau