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

425of the United States Pharmacopeia or the National Formulary if recognizedtherein. If it is in an oral form designed to minimize its potential for abuse, andis not recognized in the U.S. P. or N.F., assurance that the drug meets adequatespecifications for its intended use should be provided. This information may beobtained from the manufacturer. If bulk powder is used, a statement detailinghow it is to be formulated, the name and qualifications of the person formulatingthe dosage form, and the address of where the formulating will take place if it isto take place at any location other than the principal address of the sponsor.(3) The name, address, and a summary of the scientific training and experienceof each investigator, and all other professional personnel having major responsibilityin the research and rehabilitative effort, and individuals charged withmonitoring the progress of the investigation and evaluating the safety and effectivenessof the drug if the monitor is other than a physician-sponsor. An investigator,other than a physicain-sponsor (and investigators immediately responsibleto a physician-sponsor and named in his submission) who has signed a formFD-1571 or the form entitled "Notice of Claimed Investigational Exemption forMethadone for Us e in Maintenance Treatment of Narcotic Addicts," is requiredto sign a form FD-1573, obtainable from the Food and Drug Administration.(4) A description of the facilities available to the sponsor to perform the requiredtests including the name of any hospital, institution, or clinical laboratory facilityto be employed in connection with the investigations.(.5) A statement regarding the number of subjects to be included in the program.(6) A statement of the protocol. The following is an acceptable protocol; however,it is not to be construed that this protocol must be adhered to in order toobtain clearance by the Food and Drug Administration and the Bureau of Narcoticsand Dangerous Drugs. This protocol is intended primarily as a guide forinvestigators who wish guidance in what said agencies consider acceptible. Invesgatorswho wish to do so may submit modifications of this protocol or otherprotocols; these will be judged on their merits.PROTOCOLA. Objectives. 1. To evaluate the safety of long term methadone administrationat varying dosage.2. To evaluate the efficacy of oral methadone per se in decreasing the cravingfor other narcotic drugs and in minimizing their euphoriant effect.3. To evaluate the efficacy of methadone as a pharmacological moiety infacilitating social rehabilitation of narcotic addicts.4. To determine which addicts are capable of returning to an enduring drug-freestate.B. Admission criteria. 1. Documented history of physiological dependence onone or more opiate drugs, the duration of which is to be stated.2. Confirmed history of one or more failures of treatment for their physiologicaldependence on opiates.3. Evidence of current physiological dependence on opiates.An exception to the third criterion (current physiological dependence on opiates;is allowable in exceptional circumstances for certain subjects for whom methadonemaintenance may be initiated a short time prior to or upon release from an institution.This procedure should be justified on the basis of a historj^ of previousrelapses. In these circum.stances, appropriate descriptions of the facilities, procedures,and qualifications of the personnel of the institution are to be included inthe application filed by the sponsor.Subjects who wish to do so may be transferred from one approved program toanother.C. Patients requiring special consideration— 1. Pregnant patients. Safe use ofmethadone in pregnancy has not been established. There is limited documentedclinical experience with pregnant patients treated with methadone, and animalreproduction studies have not been done. It is therefore preferable that pregnantpatients be hospitalized and withdrawn from narcotics. If such a course is notfeasible, pregnant patients may be included provided the patient is informed ofthe possible hazard. To minimize the risk of physiological dependence of the newborn, or other complications, pregnant women should be maintained on minimaldosage. The investigator should promptly report to the Food and Drug Administrationthe condition of each infant born to a mother in a methadone maintenanceprogram.2. Patients with serious physical illness. Patients with serious concomitantphysical illness are to be included in methadone maintenance program only when