Clinical investigations of the therapeutic potential of ayahuasca: rationale and regulatory challenges

Airaksinen, 1981, β-Carbolines, psychoactive compounds in the mammalian body, Med Biol, 59, 21 Allen, 1980, The simple β-carboline alkaloids, Phytochemistry, 19, 1573, 10.1016/S0031-9422(00)83773-5 Anonymous, 1855, Journal of a voyage up the Amazon and Rio Negro by Richard Spruce, San Carlos del Rio Negro, June 27, 1853, Hooker J Bot Kew Garden Misc, 6/7 Barker, 1980, Metabolism of the hallucinogen N,N-dimethyltryptamine in rat brain homogenates, Biochem Pharmacol, 29, 1049, 10.1016/0006-2952(80)90169-0 Barker, 1981, N,N-Dimethyltryptamine: an endogenous hallucinogen, Int Rev Neurobiol, 22, 83, 10.1016/S0074-7742(08)60291-3 Blakely, 2000, Biogenic amine transporters: regulation in flux, Curr Opin Neurobiol, 10, 328, 10.1016/S0959-4388(00)00088-X 1982 Buckholtz, 1976, Effects of tetrahydro-β-carbolines on monoamine oxidase and serotonin uptake in mouse brain, Biochem Pharmacol, 25, 2319, 10.1016/0006-2952(76)90016-2 Buckholtz, 1977, Monoamine oxidase inhibition in brain and liver produced by B-carbolines: structure-activity relationships and substrate specificity, Biochem Pharmacol, 26, 1991, 10.1016/0006-2952(77)90007-7 Burroughs, 1963 Callaway, 1988, A proposed mechanism for the visions of dream sleep, Med Hypotheses, 26, 119, 10.1016/0306-9877(88)90064-3 Callaway, 1994, Platelet serotonin uptake sites increased in drinkers of ayahuasca, Psychopharmacology, 116, 385, 10.1007/BF02245347 Callaway, 1996, Quantitation of N,N-dimethyltryptamine and harmala alkaloids in human plasma after oral dosing with Ayahuasca, J Anal Toxicol, 20, 492, 10.1093/jat/20.6.492 Callaway, 1999, Pharmacokinetics of hoasca alkaloids in healthy humans, J Ethnopharmacol, 65, 243, 10.1016/S0378-8741(98)00168-8 Canessa, 1973, Harmaline: a competitive inhibitor of Na+ ion in the (Na+/K+)ATPase system, J Membr Biol, 13, 263, 10.1007/BF01868232 Center for Cognitive Liberty and Ethics (2002a). Federal court rules in favor of ayahuasca-using church [Press release]. Available at: http://www.cognitiveliberty.org/dll/udv_pj_granted.htm. Center for Cognitive Liberty and Ethics. (2002b). Uniao do Vegetal (UDV) v. United States. Case Chronology as of Dec. 2002. Available at: http://www.cognitiveliberty.org/dll/udv_index.htm. Coccaro, 1989, Serotonergic studies in patients with affective and personality disorders. Correlates with suicidal and impulsive aggressive behavior, Arch Gen Psychiatry, 46, 587, 10.1001/archpsyc.1989.01810070013002 Cook, 1997, Evidence of linkage between the serotonin transporter and autistic disorder, Mol Psychiatry, 2, 247, 10.1038/sj.mp.4000266 Davis, 1996 de Sousa, 1978, Vasopressin-like effects of a hallucinogenic drug—harmaline—on sodium and water transport, J Membr Biol, 40, 77, 10.1007/BF01909740 Deuloufeu, 1967, Chemical constituents isolated from Banisteriopsis and related species, Psychopharmacol Bull, 4, 17 Dobkin de Rios, 1972, Visionary vine: psychedelic healing in the Peruvian Amazon, Int J Soc Psychiatry, 17, 256, 10.1177/002076407101700402 Dobkin de Rios, 1973, Curing with ayahuasca in an urban slum, 67 Dobkin de Rios, 1994, Drug tourism in the Amazon, Omni, 20 FDA/CDER Center for Drug Evaluation and Research (2002). Guidance for industry: botanical drug products. Available at: http://www.fda.gov/cder/guidance/1221dft.htm. Ferguson, 1972, Action of alkaloidal extract of Banisteriopsis quitensis on rabbit ileum, J Pharm Sci, 61, 23, 10.1002/jps.2600610429 Fischman, 1983, Dreams, hallucinogenic drug states, and schizophrenia: a psychological and biological comparison, Schizophr Bull, 9, 73, 10.1093/schbul/9.1.73 Franco-Molina, 2003, In vitro immunopotentiating properties and tumour cell toxicity induced by Lophophora williamsii (Peyote) cactus methanolic extract, Phytother Res, 17, 1076, 10.1002/ptr.1313 Grob, 1996, Human pharmacology of hoasca, a plant hallucinogen used in ritual context in Brazil, J Nerv Ment Dis, 184, 86, 10.1097/00005053-199602000-00004 Hallikainen, 1999, Association between low activity serotonin transporter promoter genotype and early onset alcoholism with habitual impulsive violent behavior, Mol Psychiatry, 4, 385, 10.1038/sj.mp.4000526 Halpern, 2001, Hallucinogens on the Internet: a vast new source of underground drug information, Am J Psychiatry, 158, 481, 10.1176/appi.ajp.158.3.481 Hashimoto, 1975, New organic bases from Amazonian Banisteriopsis caapi, Phytochemistry, 14, 1633, 10.1016/0031-9422(75)85365-9 Hashimoto, 1976, New alkaloids from Banisteriopsis caapi, Phytochemistry, 15, 1559, 10.1016/S0031-9422(00)88936-0 Hayashi, 1977, Interactions of harman and norharman with DNA, Nucleic Acids Res, 4, 3679, 10.1093/nar/4.11.3679 Heckenberger, 2003, Amazonia 1492: pristine forest or cultural parkland?, Science, 301, 1710, 10.1126/science.1086112 Ho, 1979, Pharmacological and biochemical studies with β-carboline analogs, vol. 4, 215 Hopp, 1976, In vitro antitrypanosomal activity of certain alkaloids against Trypanosoma lewisi, Lloydia, 39, 375 Hrinda, 1987, Regulation of high- and low-[3H]-imipramine sites in rat brain by chronic treatment with antidepressants, Eur J Pharmacol, 138, 159, 10.1016/0014-2999(87)90429-8 Johnson, 1984, Pharmacology of methyl- and propyl-B-carbolines in a hereditary model of epilepsy, Neuropharmacology, 23, 1015, 10.1016/0028-3908(84)90122-9 Kawanishi, 1982, Shinunine and dihydroshihunine from Banisteriopsis caapi, J Nat Products, 45, 637, 10.1021/np50023a021 Klein, 2000, From food to nutritional support to specific nutraceuticals: a journey across time in the treatment of disease, J Gastroenterol Suppl, 12, 1 Krajick, 1992, Vision quest, Newsweek, 44 Lamb, 1971 Langer, 1984, Possible endocrine role of the pineal gland for 6-methoxytetrahydro-β-carboline, a putative endogenous neuromodulator of the [3H]imipramine recognition site, Eur J Pharmacol, 102, 379, 10.1016/0014-2999(84)90275-9 Lesch, 1993, Regional brain expression of serotonin transporter mRNA and its regulation by reuptake inhibiting antidepressants, Mol Brain Res, 17, 31, 10.1016/0169-328X(93)90069-2 Lesch, 1996, Association of anxiety-related traits with a polymorphism in the serotonin transporter gene regulatory region, Science, 274, 1527, 10.1126/science.274.5292.1527 Lippke, 1983, β-Carbolines as benzodiazepine receptor ligands: 1. Synthesis and benzodiazepine receptor interaction of esters of β-carboline-3-carboxylic acid, J Med Chem, 26, 499, 10.1021/jm00358a008 Little, 1998, Cocaine, ethanol, and genotype effects on human midbrain serotonin transporter binding sites and mRNA levels, Am J Psychiatry, 155, 207, 10.1176/ajp.155.2.207 Luna, 1984, The concept of plants as teachers among four mestizo shamans of Iquitos, northeast Peru, J Ethnopharmacol, 11, 135, 10.1016/0378-8741(84)90036-9 Luna, 1984, The healing practices of a Peruvian shaman, J Ethnopharmacol, 11, 123, 10.1016/0378-8741(84)90035-7 Luna, 1986 Luna, 1991 Marazziti, 1989, Age related differences in human platelet 5-HT uptake, Naunyn-Schmiedeberg's Arch Pharmacol, 340, 593, 10.1007/BF00260616 McKenna, 1999, Ayahuasca: An ethnopharmacologic history, 187 McKenna, 1981, Ultra-violet mediated cytotoxic activity of β-carboline alkaloids, Phytochemistry, 20, 1001, 10.1016/0031-9422(81)83017-8 McKenna, 1984, Biochemistry and pharmacology of tryptamine and β-carboline derivatives: a minireview, J Psychoact Drugs, 16, 347, 10.1080/02791072.1984.10472305 McKenna, 1985, On the comparative ethnopharmacology of the malpighiaceous and myristicaceous hallucinogens, J Psychoact Drugs, 17, 35, 10.1080/02791072.1985.10472316 McKenna, 1984, Monoamine oxidase inhibitors in South American hallucinogenic plants: tryptamine and β-carboline constituents of ayahuasca, J Ethnopharmacol, 10, 195, 10.1016/0378-8741(84)90003-5 McKenna, 1995, Biodynamic constituents in Ayahuasca admixture plants: an uninvestigated folk pharmacopoeia, 349 Morin, 1984, β-Carboline kindling of the benzodiazepine receptor, Brain Res, 321, 151, 10.1016/0006-8993(84)90692-9 Naranjo, 1979, Hallucinogenic plant use and related indigenous belief systems in the Ecuadorian Amazon, J Ethnopharmacol, 1, 121, 10.1016/0378-8741(79)90003-5 Naranjo, 1986, El ayahuasca in la arqueologı́a ecuatoriana, Am Indig, 46, 117 Nichols, 1991, Stereochemical aspects of hallucinogenesis, vol. III, 1 O Centro Espirita Beneficiente Uñiao do Vegetal, et al., v. Janet Reno, et al. (2000). Case No. CV 00-1647 in the US District Court for the District of New Mexico Plaintiffs' Original Complaint for Declaratory and Injunctive Relief. O'Connell, 1969, Isolation of caffeine from Banisteriopsis inebrians (Malpighiaceae), Naturwissenschaften, 56, 139, 10.1007/BF00601038 Ott, 1993 Pahkla, 1997, Binding of pinoline on the 5-hydroxytryptamine transporter: competitive interaction with [3H] citalopram, Pharmacol Toxicol, 80, 122, 10.1111/j.1600-0773.1997.tb00384.x Pletscher, 1980, Use and limitations of platelets as models for neurons: amine release and shape change reaction, 267 Rahwan, 1975, Toxic effects of ethanol—possible role of acetaldehyde, tetrahydroisoquinolines, and tetrahydro-β-carbolines, Toxicol Appl Pharmacol, 24, 3, 10.1016/0041-008X(75)90171-4 Riba, 2001, Psychometric assessment of the Hallucinogen Rating Scale, Drug Alcohol Depend, 62, 215, 10.1016/S0376-8716(00)00175-7 Riba, 2001, Subjective effects and tolerability of the South American psychoactive beverage Ayahuasca in healthy volunteers, Psychopharmacol (Berl), 54, 85, 10.1007/s002130000606 Riba, 2002, Topographic pharmaco-EEG mapping of the effects of the South American beverage ayahuascain healthy volunteers, Br J Clin Pharmacol, 53, 613, 10.1046/j.1365-2125.2002.01609.x Riba, 2002, Effects of ayahuascaon sensory and sensorimotor gating in humans as measured by P50 suppression and prepulse inhibition of the startle reflex, respectively, Psychopharmacol (Berl), 165, 18, 10.1007/s00213-002-1237-5 Riba, 2003, Human pharmacology of ayahuasca: subjective and cardiovascular effects, monoamine metabolite excretion, and pharmacokinetics, J Pharmacol Exp Ther, 306, 73, 10.1124/jpet.103.049882 Rivier, 1972, Ayahausca, the South American hallucinogenic drink: ethnobotanical and chemical investigations, Econ Bot, 29, 101, 10.1007/BF02860772 Rocca, 1989, Light-dark differences in [3H]-paroxetine binding in rabbit platelet membranes, Naunyn-Schmiedeberg's Arch Pharmacol, 340, 41, 10.1007/BF00169205 Rodriguez, 1982, The possible role of Amazonian psychoactive plants in the chemotherapy of parasitic worms: a hypothesis, J Ethnopharmacol, 6, 303, 10.1016/0378-8741(82)90053-8 Rommelspacher, 1980, Excretion of tetrahydroharmane and harmane into the urine of man after a load with ethanol, FEBS Lett, 109, 209, 10.1016/0014-5793(80)81088-X Rotman, 1983, Blood platelets in psychopharmacological research, Prog Neuro-psychopharmacol Biol Psychiatry, 7, 135, 10.1016/0278-5846(83)90101-X Roy, 1991, Cerebrospinal fluid variables among alcoholics lack seasonal variation, Acta Psychiatr Scand, 84, 579, 10.1111/j.1600-0447.1991.tb03199.x Schaepe, L. (2001). International control of the preparation “ayahuasca.” United Nations International Control Board. Opinion letter submitted to Mr. Lousberg, Chief, Inspectorate for Health Care, Ministry of Public Health, Den Haag, the Netherlands. Introduced in evidence in O Centro Espirita Beneficiente Uñiao do Vegetal et al. v. Janet Reno et al., Case No. CV 00-1647 JP/RLP (application for preliminary injunction) in the US District Court for the District of New Mexico to the Hon. James A. Parker Chief Judge. Schultes, 1957, The identity of the malpighiaceous narcotics of South America, Bot Mus Leaf Harv Univ, 18, 1 Schultes, 1972, Ethnotoxocological significance of additives to New World hallucinogens, Plant Sci Bull, 18, 34 Schultes, 1980 Schwarz, 2003, Activities of extract and constituents of Banisteriopsis caapi relevant to parkinsonism, Pharmacol Biochem Behav, 75, 627, 10.1016/S0091-3057(03)00129-1 Sher, 2000, Pleiotropy of the serotonin transporter gene for seasonality and neuroticism, Psychiatr Genet, 10, 125, 10.1097/00041444-200010030-00004 Shulgin, 1982, Psychotomimetic drugs: structure-activity relationships, vol. 11, 243 Shulgin, 1997 Smith, 1977, Tryptamine and related compounds in plants, Phytochemistry, 16, 17 Stafford, 1977 Stahl, 1977, The human platelet: a diagnostic and research tool for the study of biogenic amines in psychiatric and neurologic disorders, Arch Gen Psychiatry, 34, 509, 10.1001/archpsyc.1977.01770170019001 Strassman, 1994, Dose-response study of N,N-dimethyltryptamine in humans: I. neuroendocrine, autonomic, and cardiovascular effects, Arch Gen Psychiatry, 51, 85, 10.1001/archpsyc.1994.03950020009001 Strassman, 1994, Dose-response study of N,N-dimethyltryptamine in humans. II. Subjective effects and preliminary results of a new rating scale, Arch Gen Psychiatry, 51, 98, 10.1001/archpsyc.1994.03950020022002 Stull, 1971, Selected pharmacological studies of an alkaloidal extract of Banisteriopsis quitensis, J Pharm Sci, 60, 1121, 10.1002/jps.2600600822 Suzuki, 1981, Characterization of eight biogenic indoleamines as substrates for type A and type B monoamine oxidase, Biochem Pharmacol, 30, 1353, 10.1016/0006-2952(81)90320-8 Szara, 1956, Dimethyltryptamine: its metabolism in man; the relation of its psychotic effect to the serotonin metabolism, Experientia, 12, 411, 10.1007/BF02157378 Taylor, 1984, Effects of 6-methoxytetrahydro-β-carboline on 5-hydroxytryptamine binding in rat brain, J Pharm Pharmacol, 36, 125, 10.1111/j.2042-7158.1984.tb03010.x Tiihonen, 1997, Single-photon emission tomography imaging of monoamine transporters in impulsive violent behavior, Eur J Nucl Med, 24, 1253, 10.1007/s002590050149 Topping, 1998, Ayahuasca and cancer: one man's experience, Bull Multidiscip Assoc Psychedelic Stud, 8, 22 Towers, 1983, UV-mediated genotoxicity of furanoquinoline and of certain tryptophan-derived alkaloids, J Nat Products, 46, 576, 10.1021/np50028a027 Udenfriend, 1958, Studies with reversible inhibitors of monoamine oxidase: harmaline and related compounds, Biochem Pharmacol, 1, 160, 10.1016/0006-2952(58)90025-X Uebelhack, 1983, Methylated and unmethylated indolarmine in the cisternal fluid in acute endogenous psychosis, Biomed Biochem Acta, 42, 1343 Umezawa, 1978, Co-mutagenic effect of harman and norharman with 2-acetyl-aminoflourine derivatives, Proc Natl Acad Sci USA, 75, 928, 10.1073/pnas.75.2.928 Weil, 1980, In the land of yage, 99 Westlaw Citation # 31862699 (2002). Available at: http://nvo.com/cd/nss-folder/pubfiles/emerstay.htm. Wilasrusmee, 2002, In vitro immunomodulatory effects of ten commonly used herbs on murine lymphocytes, J Altern Complement Med, 8, 467, 10.1089/107555302760253667 Wilasrusmee, 2002, In vitro immunomodulatory effects of herbal products, Am Surg, 68, 860, 10.1177/000313480206801005 Winkelman, 1995, Psychointegrator plants: their roles in human consciousness, cultures, and health, Yearb Cross-Cult Med Psychother, 9 Yasuhara, 1974, Studies on monoamine oxidase (report XXIV). Effect of harmine on monoamine oxidase, Jpn J Pharmacol, 24, 523, 10.1254/jjp.24.523 Yasuhara, 1972, Differences in the actions of harmine on the oxidations of serotonin and tyramine by beef brain mitochondrial MAO, Jpn J Pharmacol, 22, 439, 10.1254/jjp.22.439 Yritia, 2002, Determination of N,N-dimethyltryptamine and beta-carboline alkaloids in human plasma following oral administration of ayahuasca, J Chromatogr B Anal Technol Biomed Life Sci, 779, 271, 10.1016/S1570-0232(02)00397-5