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

426comprehensive medical care is available. Such patients require careful observationfor any adverse effects of methadone and interactions with other medications.The investigator should promptly report adverse effects and evidence of interactionsto the Food and Drug Administration.3. Psychotic patients. Psychotic patients may be included in methadone maintenanceprograms when adequate psychiatric consultation and care is available.Administration of concomitant psychotropic agents requires careful observationfor possible drug interaction. Such occurrences should be promptly reported.Investigators who intend to include in their programs patients in categories 1,2, and/or 3 above should so state in their protocols and should give assurance ofappropriate precautions.4. Patients less than 18 years of age. It is imperative that adolescents be affordedthe benefit of other treatment modalities whenever possible and that those withminimal histories of physiological dependence be excluded from methadone maintenanceprograms. Investigators who wish to include adolescents in the programare therefore required to submit special protocols for this purpose. These protocolsshould state in detail the number of such patients to be treated, the alternativetreatment methods available, the criteria for selection, the screening procedures,and the ancillary procedures to be employed.D. Admission evaluation. 1. Recorded history to include age, sex, history ofarrests and convictions, educational level, employment history, and past andpresent history of drug abuse of all types.2. Medical history of significant illnesses.3. History of prior psychiatric evaluation and/or treatment.4. Assessment of the degree of physical dependence on and psychic cravingfor narcotics and other drugs, and evaluation of the attitudes toward and motivationsfor participation in the program.5. Formal psychiatric examination in subjects with a prior history of psychiatrictreatment and in those in whom there is a question of psychosis and/or competenceto give informed consent.6. Physical examination.7. Chest X-ray.8. Laboratory examinations to include complete blood count, routine urinalysis,liver function studies (including SGOT, alkaline phosphatase, and total proteinand albumin globulin ratio), blood urea nitrogen, and serologic test for syphiilis.E. Procedure.— 1. Dosage and administration. The methadone is to be administeredin an oral form so formulated as to minimize misuse by parenteral injection.The initial dosage is to be low ; for example, 20 milligrams per day. Subsequently,the dosage is to be adjusted individually, as tolerated and as required, up to 160milligrams per day. In exceptional cases, investigators may find it essential toexceed this dosage to obtain the intended effect. If such cases are encountered,the initial protocol or an amended protocol should include the maximum dosageto be administered, the number of patients for whom such dosage is required, anda description of the considerations leading to svich dosage levels. The methadoneis to be administered under the close supervision of the investigator or responsiblepersons designated by him. Initially, the subject is to receive the medication underobservation each day. After demonstrating adherence to the program, the subjectmay be permitted twice weekly observed medication intake with no more than a3-day supply rountinel^y allowed in his possession. Additional medication may])e provided in exce]3tional circumstances, such as illness, family crisis, or necessarytravel, where hardship would result from reciuiring the customary observedmedication intake for the specific period in question.2. Urinalysis. Urine collection is to be supervised; urine specimens are to beanalyzed for methadone, morphine, quinine, cocaine, barbiturates, and amphetamines;urine specimens are to be pooled or selected randomly for analj'sis atintervals not exceeding 1 week.3. Rehabilitative measures. Rehabilitative measures as indicated may includeindividual and/or grouj) psychotherapy, counseling, vocational guidance, and joband educational placement.4. Abnormalities. There shall be adequate investigation and appropriatemanagement (including necessary referral and consultation) of any abnormalitiesdetected on the basis of history, {)liysical examination, or laboratory examinationat the time of admission to the program or subsequently-, including evaluationand treatment of intercurrent physical illness with observation for complicationswhich might result from methadone.