http://exhibits.library.stonybrook.edu/mfp/files/original/313213085687d3724b6102f4a6311ac7.pdf 72182f288e5d49f536ed376b2dbfffec PDF Text Text May 16, 197h Miss Mary Carol Revmann SAODAP Place, N.W. washington, 9.0. 20506 726 Jackson Dear Miss Newmann: we would be pleased to cooPerate in the analysis of the records to he collected in the SAODAP LdAM~methadone compari— son study. As I understand the problem, the principal question is to define the efficacy and the safety of s new pleparetion, levemethsdyl, in comparison with the standard treatment, methadone. The EEG data is suggested as an index of safety, to define the degree of changes in EEG as a measure of brain function during EEG treatment. In our studies of methadone and levomethsdyl, we observed systematic changes in the EEG with both compounds. The changes related to the dose of each compound, the time after adminis~ tration, and to the time intthe induction (build-us; to the opioid. Our studies with methadone defined persistent changes during the 'vere h—6 weeks with episodes of EEG slowing and which burst activity disappeared once a maintenance-dose was stabilized and the patient received his dosage regularly. Dosage regularity was important, for in a few instances we Observed theta ,‘burst activity in patients on maintenance therapy (100 mg methadone) than drug intake was irregular or some additional substances were build~up period of used, usually opiates. ‘ it For this reason, could be important that the observatwo tions be comparable in the groups, particularly as to the _regularity with which the dosages are given and the number of hours siter a dose the EEG is recorded. As is usual with Quantitative EEG analysis, the state of alertness of the sdee must be con» trolled; we do so by recording each sthect at the some time of t �Mhry Carol Hewmann ~2- May 16, 197h day, with the recording made with eyes closed for h minute 20 seconds out of every five minute sample - that is, the subjects open their eyes and answer a simple inquiry every five minutes. we believe a 20 minute sample to be an adequate estimate of an EEG for our purposes. The sample should be in five minute blocs with a to second eye opening in between. The details of the recording for our analyses are described in the enclosed memorandum. The initial data reduction may be either by period anal~ ysis or by power spectral density analysis. We have found both useful for drug classification work. Unless your consultants request otherwise, I would recommend period analysis primary wave and first derivative, using 20 second epochs, and 320 sps sampling rate. We would analyse one load pair, preferably occipital~vertex first; and only do a second if there are questions that are left unanswered by the first analysis. We suggest that the recording on magnetic tape be of the occipital-vertex, anterior temporal-occipital, and frontalwoccipital electrode leads on one side. Should there be a question of differences in symmetry, then a pair of symmetric leads may be recorded and analysed. If the records are presented cleanly on the tape, we can l/h real time for period analysis or real time for power spectral density analysis. process the data at fer each record by period analderive standard scores by contrasting the drug periods with the pro-drug record. If a pro—drug record is not available, then we can contrast the drug changes with the initial record in each'subject, should you define the first records as equivalent for subJects beiteen groups. Having reduced the data ysis (or PWRS), we these contrasts are or louminute averages; and the changes in the two groups assessed by an appropriate multivariate statist— reduced ical The standard scores derived from to either 5—minute to contrast the changes induced by methadone and leveSince no placebo group is available, the final statements are limited to descriptions of the changes associated with each condition; the changes in time; the identification or individuals who are outside 2 or 3 SD from the mean of the group; and a contrast of the levomethadyl changes with those occuring after methadone. Should the changes be consistent with previous experience, it may be possible for either Professor Roubicek, Dr. Vblavka, or myself to method methadyl. contrast the observations with the data recorded earlier at the studies. NYMC �szmw n: hhry'Csrol Newmenn The w-vuwu- um..- -‘ .. .n- 7.. w..,..,.... .. ‘n-nmwr ~3~ w .7...“ __,. -w. c, V. . .. "I'V-‘mum‘;§~w ' facilities at the Health Sciences May p. —,,.‘.- n. we in. ....., , on. c ., ..... .. 16, 197k Center at Stony these analyses for records provided on compet— ible tapes. This laboratory is supported in large part by grants from the National Institute of mental Health and the National Institute of Drug Abuse. we can, therefore, to the extent these other funds are available, provide the analyses at reduced cost Brook can provide SAODAP. The 2&0 hours of EEG estimated to be recorded by Sharon/Burch and the 150 hours by Resnick/Volavke could be re— duced in 100 hours of machine/operator time at $1¢ui§/951- to we ‘f would estimate an additional 2 weeks of operator time IBM 370—65 machine time for the statistical ena1~ “”“"EEETIh’hours of yses provided in this study. Should the analyses requested by the committee be more sophisticated then re can provide, we can provide the committee with the data in card format on Hollerith cards or IBM compatible tape for statistical analyses elsewhere. . Our budget should include travel funds for two trips to Texas by a member of the staff; and two trips to New York. The option of whether the trip is made from New York to Texas or the reverse must be left in our hands. also request an allowance of $4Zfi5. for telephone pend other special charges that may facilitate this proJect. The budget estimate does not include any fees for the investigators in my laboratory. We are under contract HEM h2—73-260 and we would use the support of that program for the remainder of 19Th to cover any time charges for the investigators in this labor— atory. particularly myself~and Mr. Peter Irwin. Should theweproject re~ ‘proceed beyond the December 31. l97h end of that contract, for 201/month the of operation of 1975 funds the at rate in quest Mr. the study. Irvin manage to of the services Budget estimates are attached, reflecting these suggestions. Should you wish to approve such a contract. the additional funds may be added to contract DA hPGOOS, Arthur Zeke, M.D., principal investigator, through the International Association for Psychiatric Research. That agency is also the grantee for PHS funds fer the program "EEG and Human Psychopharmscology", ME 2&020, which provides support for the computational equipment which is needed for the analyses de— scribed in this memorandum. we V �Mery Carol Newmann Hey 16, l97h -h— I trust these comments are helpful. We would be pre~ Irwin or another member of my staff to Texas to staff there in the proper recording of the data for analysis. It may be helpful for Dr. Stillman or you to visit our laboratories to discuss the work further. we are prepared to meet with Dr. Stillman and the investigators to design the actual recording times and sessions to maximize the data for the questions which are to be answered by these analyses. pared to send work with the tapes; I Mr. am enclosing a set of notes for recording and identifying and a budget estimate. Thank you for your inquiry. Sincerely yours, Fink, M. D. Professor of Psychiatry Max Merd Enclosure �qua-m.— wg,‘:va.y"" may 16, l97h msry Carol Newmsnn, Max Fink, M. SAODAP D. Budget Estimates for LAAM—Msthsdono EEG Analyses is provided for the analysis of she single lead pair to be collected by Shsrms/Burch; and 150 hours EEG, single lead to be collected by Bosnick/ Vblaxka. Analysis by period analysis, l/h real time.“ hours EEG, This estimate Primary Reduction 390 hours I l/h x $1h.50/hr $ 1,h00.00 Artefact control (100 hr x $5/hr) 500.00 Data compression 200.00 Statistical Processing 1—]: .d'n'r— "r Operator time (2 wk 0 $250/sk) Computer time (370/65 s $2oo/hr x Summary Reports 500.00 hr) h 800.00 (1 wk) Travsl 250.00 . 1,000.00 Incidental Costs (tsl.,postags) 250.00 2 arr-r1?!” After 1/1/75. Personnel costs 20% x $1,h00/msn . $280/msh a 8,220.00 IAPR Overboad Zhfl 7.: a v'fimnhr Var-159149: 20.00 “Should power spectral density analysis be requested, change estimate to a real time analysis by multiplying primary reduction cost by h. .00 $10,193.00 1 � 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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