A Clinical Plan for MDMA (Ecstasy) in the Treatment of Posttraumatic Stress Disorder (PTSD): Partnering with the FDA

REFERENCES

• Baggott , M. , Jerome , I. and Stuart , R. 2001 . 3,4- methylenedioxymethamphetamine (MDMA)—A review of the English-language scientific and medical literature Available at the MAPS website: http://www.maps.org/research/mdma/protocol/litreview.htmlSubmitted to FDA as part of IND # 63,384
   Google Scholar
• Bolla , K. , McCann , U. and Ricaurte , G. 1998 . Impairment in abstinent MDMA (“Ecstasy”) users . Neurology , 51 ( 6 ) : 1532 – 37 .
   PubMed Web of Science ®Google Scholar
• Croft , R. , Mackay , A. , Mills , A. and Gruzelier , J. 2001 . The relative contributions of ecstasy and cannabis to cognitive impairment . Psychopharmacology (Berlin) , 153 ( 3 ) : 373 – 79 .
   PubMed Web of Science ®Google Scholar
• Cami , J. , Farre , M. , Mas , M. , Roset , P. , Poudevida , S. , Mas , A. , San , L. and de la Torre , R. 2000 . Human pharmacology of 3,4-methylenedioxymethamphetamine (“ecstasy”): Psychomotor performance and subjective effects . Journal of Clinical Psychopharmacology , 20 ( 4 ) : 455 – 66 .
   PubMed Web of Science ®Google Scholar
• de la Torre , R. , Farre , M. , Ortuno , J. , Mas , M. , Brenneisen , R. , Roset , P. , Segura , J. and Cami , J. 2000 . Non-linear pharmacokinetics ofMDMA (“ecstasy”) in humans . British Journal of Clinical Pharmacology , 49 ( 2 ) : 104 – 09 .
   PubMed Web of Science ®Google Scholar
• Doblin , R. 2001 . The Regulation of the medical use of psychedelics and marijuana Kennedy School of Government, Harvard University. . available at http://www.maps.orgUnpublished public policy doctoral dissertation
   Google Scholar
• Everhart , E. , Jacob , P. III , Shwonek , P. , Baggott , M. , Jones , R. and Mendelson , J. Estimation of the metabolic disposition of MDMA and MDA enantiomers in humans . Abstracts of the College on Problems of Drug Dependence (CPDD) Annual Meeting . pp. 41
   Google Scholar
• Fallon , J. , Kicman , A. , Henry , J. , Milligan , P. , Cowan , D. and Hutt , A. 1999 . Stereospecific analysis and enantiomeric disposition of 3, 4-methylenedioxymethamphetamine (Ecstasy) in humans . Clinical Chemistry , 45 ( 7 ) : 1058 – 69 . [Published erratum appears in Clinical Chemistry 45 (9): 1585.]
   PubMed Web of Science ®Google Scholar
• Fischer , C. , Hatzidimitriou , G. , Wlos , J. , Katz , J. and Ricaurte , G. 1995 . Reorganization of ascending 5-HT axon projections in animals previously exposed to the recreational drug (+/-)3,4-methylenedioxymethamphetamine (MDMA, “ecstasy”) . Journal of Neuroscience , 15 ( 8 ) : 5476 – 85 .
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration . 1998 . “ Providing clinical evidence of effectiveness for human drug and biological products. ” . In FDA Guidance for Industry. Available at http://www.fda.gov/cder/guidance/1397fnl.pdf
   Google Scholar
• Friedman , L. , Furberg , C. and Demets , D. 1985 . The Fundamentals of Clinical Trials. , 2nd Edition St. Louis : Mosby-Year Book. .
   Google Scholar
• Gamma , A. 2001 . Does Ecstasy cause memory deficits. A review of studies of memory function in Ecstasy users Available at the MAPS website: http://www.maps.org/research/mdma/mdmamemory.html
   Google Scholar
• Gouzoulis-Mayfrank , E. , Daumann , J. , Thchtenhagen , F. , Pelz , S. , Becker , S. , Kunert , H. , Fimm , B. and Sass , H. 2000 . Impaired cognitive performance in drug free users of recreational ecstasy (MDMA) . Journal of Neurology, Neurosurgery and Psychiatry , 68 ( 6 ) : 719 – 25 .
   PubMed Web of Science ®Google Scholar
• Grob , C. , Poland , R. , Chang , L. and Ernst , T. 1996 . Psychobiologic effects of 3,4-methylenedioxymethamphetamine in humans: Methodological considerations and preliminary observations . Behavior and Brain Research. , 73 ( 1–2 ) : 103 – 7 .
   PubMed Web of Science ®Google Scholar
• Hatzidimitriou , G. , McCann , U. and Ricaurte , G. 1999 . Altered serotonin innervation patterns in the forebrain of monkeys treated with (+/-)3,4-methylenedioxymethamphetamine seven years previously: Factors influencing abnormal recovery . Journal of Neuroscience , 19 ( 12 ) : 5096 – 107 .
   PubMed Web of Science ®Google Scholar
• Helmlin , H. , Bracher , K. , Bourquin , D. , Vonlanthen , D. and Brenneisen , R. 1996 . Analysis of 3,4-methylenedioxymethamphetamine (MDMA) and its metabolites in plasma and urine by HPLC-DAD and GC-MS . Journal of Analytical Toxicology , 20 ( 6 ) : 432 – 40 .
   PubMed Web of Science ®Google Scholar
• Henry , J. , Fallon , J. , Kicman , A. , Hutt , A. , Cowan , D. and Forsling , M. 1998 . Low-dose MDMA (“ecstasy”) induces vasopressin secretion . Lancet , 351 ( 9118 ) : 1784
   PubMed Web of Science ®Google Scholar
• Hernandez-Lopez , C. , Farre , M. , Roset , P. , Menoyo , E. , Pizarro , N. , Ortuno , J. , Torrens , M. , Cami , J. and de La Torre , R. 2002 . 3,4-methylenedioxymethamphetamine (ecstasy) and alcohol interactions in humans: Psychomotor performance, subjective effects, and pharmacokinetics . Journal of Pharmacology and Experimental Therapeutics , 300 ( 1 ) : 236 – 44 .
   PubMed Web of Science ®Google Scholar
• Johnston , L. , O'Malley , P. and Bachman , J. 2001 . Rise in Ecstasy Use Among American Teens Begins to Slow. Ann Arbor, Michigan : University of Michigan News and Information Services. .
   Google Scholar
• Katz , R. 1999 . Obtained from FDA through FOIA request, along with entire approval package for Zoloft Unpublished memorandum, December 6, 1999 from Director of Division of Neuropharmacological Drug Products to File, NDA 19–839/S-026
   Google Scholar
• Kazdin , A. and Bass , D. 1989 . Power to detect differences between alternative treatments in comparative psychotherapy outcome research . Journal of Consulting and Clinical Psychology , 57 ( 1 ) : 138 – 47 .
   PubMed Web of Science ®Google Scholar
• Leshner , A. 2001 . Club Drugs Aren't “Fun Drugs.” Available at the NIDA website: http://www.drugabuse.gov/Published_Articles/fundrugs.html
   Google Scholar
• Lieberman , J. and Aghajanian , G. 1999 . Caveat emptor: Researcher beware . Neuropsychopharmacology , 21 ( 4 ) : 471 – 3 .
   PubMed Web of Science ®Google Scholar
• Liechti , M. , Baumann , C. , Gamma , A. and Vollenweider , F. 2000 . Acute psychological effects of 3,4-Methylenedioxymethamphetamine (MDMA, “Ecstasy”) are attenuated by the serotonin uptake inhibitor citalopram . Neuropsychopharmacology. , 22 ( 5 ) : 513 – 21 .
   PubMed Web of Science ®Google Scholar
• Malberg , J. and Seiden , L. 1998 . Small changes in ambient temperature cause large changes in 3,4-methylenedioxymethamphetamine (MDMA)-induced serotonin neurotoxicity and core body temperature in the rat . Journal of Neuroscience , 18 ( 13 ) : 5086 – 94 .
   PubMed Web of Science ®Google Scholar
• Malberg , J. , Sabol , K. and Seiden , L. 1996 . Co-administration of MDMA with drugs that protect against MDMA neurotoxicity produces different effects on body temperature in the rat . Journal of Pharmacology and Experimental Therapeutics , 278 ( 1 ) : 258 – 67 .
   PubMed Web of Science ®Google Scholar
• Mas , M. , Farre , M. , de la Torre , R. , Roset , P. , Ortuno , J. , Segura , J. and Cami , J. 1999 . Cardiovascular and neuroendocrine effects and pharmacokinetics of 3, 4-methylenedioxymethamphetamine in humans . Journal of Pharmacology and Experimental Therapeutics , 290 ( 1 ) : 136 – 45 .
   PubMed Web of Science ®Google Scholar
• McCann , U. , Szabo , Z. , Scheffel , U. , Dannals , R. and Ricaurte , G. 1998 . Positron emission tomographic evidence of toxic effect of MDMA (“Ecstasy”) on brain serotonin neurons in human beings . Lancet , 352 ( 9138 ) : 1433 – 37 .
   PubMed Web of Science ®Google Scholar
• Mertl , M. 2000 . Ecstasy and the brain: Club drug rants and raves Available at Brain.com. April 11
   Google Scholar
• Mithoefer , M. and Wagner , M. 2001 . A human phase II study—Safety and efficacy of 3,4-methylenedioxymethamphetamine (MDMA)- assisted psychotherapy in the treatment of chronic posttraumatic stress disorder (PTSD) Available at the MAPS website: http://www.maps.org/research/mdma/protocol/index.htmlFDA IND # 63,384
   Google Scholar
• National Drug Intelligence Center . 2000 . Draft National Drug Threat Assessment 2001: The Domestic Perspective Available at http://www.usdoj.gov/ndic/products.htm
   Google Scholar
• National Institute on Drug Abuse (NIDA) . 2000 . Emerging Drug Epidemics: Club Drugs Available at the NIDA website: http://165.112.78.61/Meetings/CiubSat.html
   Google Scholar
• Office of Applied Studies . 2001a . Mortality data from the Drug Abuse Warning Network—2000 Available at: http://www.samhsa.gov/statistics/statistics.html
   Google Scholar
• Office of Applied Studies . 2001b . Updated weighted emergency department estimates for the coterminous U.S.by year: 1994 to 2000 Available at: http://www.samhsa.gov/oas/dawn.htm
   Google Scholar
• Office of Public Affairs, United States Customs Service . 2000 . Ecstasy Seizures and Smuggling Methods Fact Sheet. Washington, D.C. : US GPO. . January 5, 2000
   Google Scholar
• Otalora , M. 1984 . MDMA and LSD therapy in the treatment of posttraumatic stress disorder in a case of sexualabuse Available at the MAPS website: http://www.maps.org/research/mdma/marcela.html
   Google Scholar
• Pacifici , R. , Zuccaro , P. , Farre , M. , Pichini , S. , Di Carlo , S. , Roset , P. , Ortuno , J. , Segura , J. and de la Torre , R. 1999 . Immunomodulating properties of MDMA alone and in combination with alcohol: A pilot study . Life Sciences , 65 ( 26 ) : PL309 – 16 .
   PubMed Web of Science ®Google Scholar
• Psychopharmacologic Drugs Advisory Committee . 1999 . Available at the FDA website: http://www.fda.gov/ohrms/dockets/ac/cder99thtm#Psychopharmacologic%20Drugs3556t1a.pdfOctober 8 meeting transcript
   Google Scholar
• Reneman , L. , Lavalaye , J. , Schmand , B. , de Wolff , F. , van den Brink , W. , den Heeten , G. and Booij , J. 2001 . Cortical serotonin transporter density and verbal memory in individuals who stopped using 3,4-methylenedioxymethamphetamine (MDMA or “ecstasy”): Preliminary findings . Archives of General Psychiatry , 58 ( 10 ) : 901 – 6 .
   PubMed Web of Science ®Google Scholar
• Ricaurte , G. , DeLanney , L. , Irwin , I. and Langston , J. 1988 . Toxic effects of MDMA on central serotonergic neurons in the primate: Importance of route and frequency of drug administration . Brain Research , 446 ( 1 ) : 165
   PubMed Web of Science ®Google Scholar
• Smith , D. 1999 . Sertraline for PTSD: NDA 19–839 Availabler at the FDA website: http://www.fda.gov/ohrms/dockets/ac/99/slides/3556sla/sld001.htm
   Google Scholar
• Sopelana , P. and Bouso , J. 1999 . Administration of 3,4-methylenedioxy-methamphetamine (MDMA) to women with chronic posttraumatic stress disorder (PTSD) as a consequence of sexual assault: A dose-finding pilot study Available at the MAPS website: http://www.maps.org/research/mdma/spain/index.htmlSpanish Drug Agency Code # 99–0309
   Google Scholar
• Stevens , S. 1999/2000 . Speaking the silence: MDMA in a couple dealing with cancer . Bulletin of the Multidisciplinary Assocation for Psychedelic Studies , 9 ( 4 ) : 31 – 34 . Also available at http://www.maps.org/news-letters/v09n4/09431sue.html
   Google Scholar
• Tancer , M. and Johanson , C. E. 2001 . The subjective effects of MDMA and MCPP in moderate MDMA users . Drug and Alcohol Dependence , 65 ( 1 ) : 97 – 101 .
   PubMed Web of Science ®Google Scholar
• Vollenweider , F. 2001 . Personal communication, September 14
   Google Scholar
• Vollenweider , F. , Gamma , A. , Liechti , M. and Huber , T. 1999a . Is a single dose ofMDMA harmless? . Neuropsychopharmacology , 21 ( 4 ) : 598 – 600 .
   PubMed Web of Science ®Google Scholar
• Vollenweider , F. , Remensberger , S. , Hell , D. and Geyer , M. 1999b . Opposite effects of 3,4-methylenedioxymethamphetamine (MDMA) on sensorimotor gating in rats versus healthy humans . Psychopharmacology (Berlin) , 143 ( 4 ) : 365 – 72 .
   PubMed Web of Science ®Google Scholar
• Vollenweider , F. , Gamma , A. , Liechti , M. and Huber , T. 1998 . Psychological and cardiovascular effects and short-term sequelae of MDMA (“ecstasy”) in MDMA-naive healthy volunteers . Neuropsychopharmacology , 19 ( 4 ) : 241 – 51 .
   PubMed Web of Science ®Google Scholar
• Zakzanis , K. and Young , D. 2001 . Memory impairment in abstinent MDMA (“Ecstasy”) users: A longitudinal investigation . Neurology , 56 ( 7 ) : 966 – 9 .
   PubMed Web of Science ®Google Scholar