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

421of the best known programs. Although the program had a very broad criteria foradmission, more applicants were not admitted to the study than were admitted.In general, those patients admitted to the study and remaining in treatment,when compared to the overall heroin addict population, tended to be older, moreoften white, and in better health. This group, which had an improved employmentstatus and reduced criminahty, was not representative of the total heroin addictpopulation. Therefore, this study, as well as others reported to date, cannot beused to generahze the results to the entire addict population.Whether those not accepted for treatment would have fared as well as thoseaccepted is unanswered. Reports have not provided the kind of data that enablesbetter patient selection. Also, data are needed to distinguish the role played bythe drug itself from the role played by the psychological, social, and occupationalrehabilitative efforts in such programs; a mai'ked proliferation of programs mayproduce many in which only the drug is used and no rehabilitation is provided.Methadone maintenance treatment ma}' be a valuable therapy in reducingheroin addiction, but we believe it is wise to proceed cautiously in moving towardits general prescription use for this purpose. We need better evidence to determinethe safet.y of this treatment. One of the hazards of methadone treatment is thatyoung drug users who are not ph3'siologicall3' dependent on heroin might becomeaddicted to methadone as a result of treatment. We do not wish to have a potentiallyvaluable therapy discredited because of its misuse by some practitionerswhile its efficacy is being evaluated.We now have 257 investigational new drug exemption (IND) numbers assignedto sponsors representing 277 methadone treatment programs. We have requested6-month status reports from these programs instead of the customary annualreports, in order to obtain adequate data as soon as possible.We expect our recently published regulations to serve as a valuable tool ininsuring compliance with existing requirements. In this regard, we have recentlyundertaken a program for the inspection of all methadone maintenance studies.By mid-July, we will have completed inspection of an initial 40 to 50 programsthroughout the country, selected on the basis of various criteria.In addition to achieving correction of any deficiencies, we hope to stimulateimproved practices and better data collecting procedures. In these inspections,whenever possible, medical officers from our Bureau of Drugs will accompanydistrict field inspectors. Bj^ the end of the year all programs will have been inspected.All of this will be done in close cooperation with the Bureau of Narcoticsand Dangerous Drugs, which in addition has its own program for surveillance ofthe methadone studies.When necessary, a sponsor will be given a time limit to correct deficiencies orface loss of his investigational status. However, before a program is terminated,we will contact local health departments, medical societies, and other approvedmethadone maintenance programs in an effort to insure that continuing treatmentfor the addicts is available.In addition to review by our own personnel, we have appointed a committee ofoutside experts to assist in evaluating data as it accumulates, as well as otheraspects of the ongoing programs. The committee will also be called on to assistin reviewing any new drug applications for methadone maintenance.The concept of narcotic blockade has stimulated a search for other drugs, drugswith no addicting potential, with greater safet.y and of longer duration thanmethadone. Acetylmethadol promises some hope in that its duration of action is72 hours in contrast to the 24 hours in which methadone remains effective. Thus,an addict could take his medication, even under supervision, on a twice weeklybasis. However, the possible toxicity of acetylmethadol needs further study.Cyclazocine is another narcotic antagonist that has been studied for the treatmentof heroin addiction. Its use has been limited, however, because it has somenarcotic actions of its own, can produce respiratory depression, and may beaddicting.Naloxone, recently approved for marketing as a narcotic antagonist, has somesimilarity to cyclazocine but lacks its narcotic actions, and in particular, does noproduce respiratory depression. Naloxone has no reported addictive potential buits short duration of action, 4 to 6 hours, limits its usefulness. It has also, likecyclazocine, been tested on a pilot study basis for the treatment of heroin addiction.It is hoped that similar agents having the properties of naloxone but a longerduration of action can be synthesized.To reduce the availability of addictive drugs, a variety of agents are beingsynthesized and tested to obtain a potent analgesic with no abuse potential. Four