http://exhibits.library.stonybrook.edu/mfp/files/original/8c957fefd6bd0fdbd7f3f6173d5a8c18.pdf 2dcc8003b816f5af13f31aabf8d63af8 PDF Text Text 7&33-07333 28 February 1974 M E M 0 R A N D U H Shreevc. M.D., Ph.D., Acting Associate Chief To: Walton From: Me: Fink. M.D.. Professor of Psychiatry Subject: Proposed Studies of Alcbhol Dependence at W. of Staff for Research, VAH~Northport Last summer we were urged st VAH~Northport to develop studies in alcoholism VAR-Northport to supplement the ongoing research the treetnent of opiate dependence. In September, a series of studies to answer three questions: efforts in we proposed Does tolerance develop to long-acting bencodiesepinee? Does tolerance to e benzodiseepine pro» vide "blockade" to alcohol (by cross- tolerance)? such blockade occurs, can it be put to clinical use in the maintenance of chronic alcohol~dependent subjects by high doses of e longvacting bencodiecepine? lf we proposed to use a new benzodiszepine, This compound is particularly promising because we have observed a duration of action that is considerably longer than other known beceodiezepinee. measured by clinical obeerva~ tions. EEG examinations, and blood level studies. I have ex~ teneive experience with this compound, both in the United States and Turkey, where I have found it to be safe to use and clini- In this project, ORE—8063. cally active. -1. �w. W. ~2- Shreeve,ph.D.,,Ph.D. 28 February 1976 Since submitting this proposal, we have been asked many questions by the Research Committee. Most questions are focussed on the legality of our use of ORF~8063, and only occasionally have questions been asked regarding the design or safety of the experiment. I believe we heve answered the design and safety questions satisfactorily. In December the Committee requested that we give them an number; I indicated that this would be a study under the IND of the Ortho Research Foundation. When they insisted on written evidence, I requested a copy of the IND letter, and the monitor sent us a letter they had on file. The letter, dated April 8, 1971, referred to studies then approved and indicated single doses were then under study. IND Since that time, the Ortho Research Foundation has submitted FDA for repeated administration of the drug in men. These studies have not only been undertaken but have been protocols to the published, and include "On two reports submitted to the the Antionrioty Properties of‘a diasspine, 268 (1973). ORE—8083. ” Committee: flaw Benso~ Curr. Ther. Res“ 15.- In this study, Sakslis end his co~workers have given ORE-8063 for 21 deys from 30~l§0 mg n day. "ass-8063, an Early Evaluation of’a New Anti— ansisty Agent." Curr. Ther. Rsa., 1§:664 (1972). In this study, Gallant end his co~workers re~ ported the treatment of 8 chronic alcoholic inpatients for an average of 25 days, from 10 mg to 160 mg daily. In addition to these two published studies, I have submitted copies of reports of my own work; and indicated that I am per~ sonslly aware of 20 additional neurotic patients treated for 6 weeks in doses up to 90 mg per day, in a study which I on monitoring in Istanbul. I also attended s conference (June, 1973) st which 7 investigators (including Sskslis end Gallant) presented date on varying dosage schedules in men for extended periods. I believe that the evidence already submitted is sufficient for the Committee to determine that ORF~8063 may be given in multiple doses-ssfely-to men. I am enclosing a copy of en IND submission dated Msy 30, 1973, received by the Bureau of �w. W. Shrcsvo, H.D., Ph.D. ~3— 28 February 1214 Jun. 1, 1973, roflecting on a protocol which requires the multiple—dose administration of this compound to psychiatric patients for periods up to six wneks. Drugs on Committee acted unwisely in its original data and that I acted unwisely in attempting to I believe that the request for IND demand. I further believe there is sufficient informa~ Committee for to judge whether such a study could be undertaken at tho VAH-Horthport. meet their tion before tho MF/cis Encl. it � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Correspondence Text A resource consisting primarily of words for reading. 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