Post Traumatic Stress Disorder — Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults
Citation(s)
Aarons DH, Rossi GV, Orzechowski RF Cardiovascular actions of three harmala alkaloids: harmine, harmaline, and harmalol. J Pharm Sci. 1977 Sep;66(9):1244-8. doi: 10.1002/jps.2600660910.
Barrett FS, Johnson MW, Griffiths RR Validation of the revised Mystical Experience Questionnaire in experimental sessions with psilocybin. J Psychopharmacol. 2015 Nov;29(11):1182-90. doi: 10.1177/0269881115609019. Epub 2015 Oct 6.
Cameron LP, Benson CJ, Dunlap LE, Olson DE Effects of N, N-Dimethyltryptamine on Rat Behaviors Relevant to Anxiety and Depression. ACS Chem Neurosci. 2018 Jul 18;9(7):1582-1590. doi: 10.1021/acschemneuro.8b00134. Epub 2018 Apr 24.
dos Santos RG Safety and side effects of ayahuasca in humans--an overview focusing on developmental toxicology. J Psychoactive Drugs. 2013 Jan-Mar;45(1):68-78. doi: 10.1080/02791072.2013.763564.
Gable RS Risk assessment of ritual use of oral dimethyltryptamine (DMT) and harmala alkaloids. Addiction. 2007 Jan;102(1):24-34. doi: 10.1111/j.1360-0443.2006.01652.x.
Griffiths R, Richards W, Johnson M, McCann U, Jesse R Mystical-type experiences occasioned by psilocybin mediate the attribution of personal meaning and spiritual significance 14 months later. J Psychopharmacol. 2008 Aug;22(6):621-32. doi: 10.1177/0269881108094300. Epub 2008 Jul 1.
Hamill J, Hallak J, Dursun SM, Baker G Ayahuasca: Psychological and Physiologic Effects, Pharmacology and Potential Uses in Addiction and Mental Illness. Curr Neuropharmacol. 2019;17(2):108-128. doi: 10.2174/1570159X16666180125095902.
Kamel SH, Ibrahim TM, Hamza SM Effect of harmine and harmaline hydrochloride on pregnancy in white rats. Zentralbl Veterinarmed A. 1971 May;18(3):230-3. doi: 10.1111/j.1439-0442.1971.tb00573.x. No abstract available.
Luna LE The healing practices of a Peruvian shaman. J Ethnopharmacol. 1984 Jul;11(2):123-33. doi: 10.1016/0378-8741(84)90035-7.
Marwood JF, Huston V, Wall KT Some cardiovascular effects of monoamine oxidase inhibitors in unanaesthetized rats. Clin Exp Pharmacol Physiol. 1985 Mar-Apr;12(2):161-8. doi: 10.1111/j.1440-1681.1985.tb02319.x.
McCabe BJ Dietary tyramine and other pressor amines in MAOI regimens: a review. J Am Diet Assoc. 1986 Aug;86(8):1059-64.
McKenna DJ, Towers GH, Abbott F Monoamine oxidase inhibitors in South American hallucinogenic plants: tryptamine and beta-carboline constituents of ayahuasca. J Ethnopharmacol. 1984 Apr;10(2):195-223. doi: 10.1016/0378-8741(84)90003-5.
McKenna DJ Ayahuasca and human destiny. J Psychoactive Drugs. 2005 Jun;37(2):231-4. doi: 10.1080/02791072.2005.10399805.
Naranjo P Hallucinogenic plant use and related indigenous belief systems in the Ecuadorian Amazon. J Ethnopharmacol. 1979 Apr;1(2):121-45. doi: 10.1016/0378-8741(79)90003-5.
O'Hearn E, Molliver ME Degeneration of Purkinje cells in parasagittal zones of the cerebellar vermis after treatment with ibogaine or harmaline. Neuroscience. 1993 Jul;55(2):303-10. doi: 10.1016/0306-4522(93)90500-f.
Riba J, McIlhenny EH, Valle M, Bouso JC, Barker SA Metabolism and disposition of N,N-dimethyltryptamine and harmala alkaloids after oral administration of ayahuasca. Drug Test Anal. 2012 Jul-Aug;4(7-8):610-6. doi: 10.1002/dta.1344. Epub 2012 Apr 19.
Santos RG, Landeira-Fernandez J, Strassman RJ, Motta V, Cruz AP Effects of ayahuasca on psychometric measures of anxiety, panic-like and hopelessness in Santo Daime members. J Ethnopharmacol. 2007 Jul 25;112(3):507-13. doi: 10.1016/j.jep.2007.04.012. Epub 2007 Apr 25.
Sklerov J, Levine B, Moore KA, King T, Fowler D A fatal intoxication following the ingestion of 5-methoxy-N,N-dimethyltryptamine in an ayahuasca preparation. J Anal Toxicol. 2005 Nov-Dec;29(8):838-41. doi: 10.1093/jat/29.8.838.
Strassman RJ, Qualls CR, Uhlenhuth EH, Kellner R Dose-response study of N,N-dimethyltryptamine in humans. II. Subjective effects and preliminary results of a new rating scale. Arch Gen Psychiatry. 1994 Feb;51(2):98-108. doi: 10.1001/archpsyc.1994.03950020022002.
Wehner FC, Thiel PG, van Rensburg SJ Mutagenicity of alkaloids in the Salmonella/microsome system. Mutat Res. 1979 Feb;66(2):187-90. doi: 10.1016/0165-1218(79)90065-x. No abstract available.
Wiltshire PE, Hawksworth DL, Edwards KJ Light microscopy can reveal the consumption of a mixture of psychotropic plant and fungal material in suspicious death. J Forensic Leg Med. 2015 Aug;34:73-80. doi: 10.1016/j.jflm.2015.05.010. Epub 2015 Jun 4. Erratum In: J Forensic Leg Med. 2016 Feb;38:121.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.