http://exhibits.library.stonybrook.edu/mfp/files/original/65b62561fa0f24e406e28ed14a806bb5.pdf 69240ec82cfabf6ba1898657ceb8f3eb PDF Text Text September 3 , 1968 Dr. John A. Scigliano Mecutive Secretary ad hoe Marimana Advisory Camittee National Institute of Mental Health Wisconsin Avenue Chevy Cruse, Maryland 20203 51450. Dear Dr. Scigliano: for your letter of August 23 referring to the Advisory Cannittee meeting of July, deferring my request for legal supplies of marijuana and me for research, pending answers to questions raised by the Committee. Thank you The following are the answers requested. First , let me imiioate that the BEG-behavioral studies of any new drug are complex and while some analyses can be accomplished with few trials, most require many experiments. The number of trials (and the mnnber of subjects) are "as many as necessary". For example, the recent analyses of fenflmemine required twenty subjects only. For heroin, however, we have completed mm than one-hundred and fifty trials in mre than seventy subjects and methadone we now have mre than eighty still areinunsatisfied. Forand probably have enough for a preliminm'y subjects twenty record: analys 5. additional problem is the rwte of ministration. We have limited experience with drugs given by inhalation. I anticipate that we will make many errors initially. For this reason the answers to the questions below are approximate. (I) How many subjects me you planning to use? An , sw/W-znanz'nm'rz Wflm.-lflfi"5‘7AY¢3meflNm79'r-T\VNY' run: mains-1 raw :‘Wx‘v (a) POM-addicts? (b) Momma? (a) 20—30, (b) 6 - 12 fewer, How How ’ if repeated many? many? trials are satisfactory. �-2- Dr. Scigliano (2) September 3, 1968 Dosage (a) Dosage to each? (b) How my doses? (a) Dosage to each? 1. Tm: 20 mg initially. This dose will be increased as needed until either EEG or behavioral effects , or both are clearly manifest. 2. (b) How many 1. 2. (3) g s E Marijuana: 'IWo "puffs" increasing to a full cigarette or nultiple cigarettes , as wmnted. doses? at least two trials per subject, If the dose response becomes of interest , probably three to five doses for each subjects. THC: THC Same and a blank. as THC. subjects to be scanned psyche/tummy (a) Post addicts: a psychiatric examination is recozded in each subject. Those with complicating diagnoses , How Me «the as depressive psychosis , schizophrenia or chronic alcoholism are excluded. E E E E Q (b) E Volunteers: Each volunteer undergoes a psychiatric examination and evidence of psychosis is sufficient reason for exclusion. In addition, we plan to include only those volunteers who admit to previous marijuana exposure in these studies. Each volunteer also completes the MW]: which we are not investmating as a screening device. (4) whet mama will be taken to pleated: the normal vomnxeu? present study progmm with normal volunteers provides the basis for the trials with marijuana and THC. The project is frankly eXplained to each suhfiect by a research assistant and then again at the end of the psychiatric interview, by one of the senior scientists. At the end of this explanation the subject is asked to sign a permit for a research study. The �-3- Dr. Scigliam Septenber 3, 1968 After each exposure, subjects are advised to undertake only limited activities for a minimnn 2n hour period. We do not permit thentodriveaoarardpayalltaxiexpenses home member and all subjects is monitored by a staff areaskedtoretumtothe 2Hlaboratoryortobe to and from the laboratory. Their return visited by a staff umber hours after exposure. In the event of an untoward reaction, admission to the Psychophamacology Research Metropolitan Hospital Ward of is assured, or for females the private pavilion of Flower and Fifth Avenue Hospitals is available. The principal investigator is m W'v- -. (5) (Um-v psychiatrist at both institutions. CW” 5M. the heaoin challenge studied - the due and whethu M4119 poet-addicts and/on newt voluntew. Heroin challenges have only been done, so far, in post-addicts. Our usual dose is 15 - 30 mg/ch saline/ 2 minutes intravermsly. When heroin is Yty'rI-‘Q'Wflmrr’vn'x given to subjects who are not receiving duonic narcotic antfionists , we administer intravenous naloxone (1 mg) at the end of the eaqaeriment and give oral naloxone (2 mg) approximately 3 hours after heroin exposure. F,¢n-.¢u~v.— Man-w, .. .— n sea-.1 V’a-zr'" Viva“ :v xy-nvawvv an attemling (6) a $221be heat £a ace «:0qu be ~ the dwge - both mau’juana and A9-THC ue compounds and the passe/med Manage l8'CC. Secwxg Ahoutd be mntained by inch and hey. .r: : <t1wemvvrwmr¢smmmrmwwrr wa'rv , 'er-r‘ W‘s,- Stability of the drugs: yes . �a. Dr. Scigliano (7) September 3, 1968 -l&- 0554mm! owe/L 5mm: - etc. Letter requested (see xerox enclosed) Sinceme yours , Fink, M.D. Professor of Psychiatry Max Mfzkp � 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. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. 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 to: Scigliano, John Type The nature or genre of the resource Text Identifier An unambiguous reference to the resource within a given context mfp-05-00-022-5-521 Date A point or period of time associated with an event in the lifecycle of the resource 1968 Creator An entity primarily responsible for making the resource <a title="Fink, Max, 1923-" href="http://id.loc.gov/authorities/names/n79039548" target="_blank">Fink, Max, 1923-</a> Subject The topic of the resource Correspondence -- Correspondence Relation A related resource The Max Fink Collection Description An account of the resource Rights Information about rights held in and over the resource <a title="IN COPYRIGHT - EDUCATIONAL USE PERMITTED" href="http://rightsstatements.org/vocab/InC-EDU/1.0/" target="_blank">IN COPYRIGHT - EDUCATIONAL USE PERMITTED</a> Source A related resource from which the described resource is derived Special Collections and University Archives, University Libraries. 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