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Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults

Primary Purpose

Major Depression, Post Traumatic Stress Disorder

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SM-001
Sponsored by
Advanced Integrative Medical Science Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Banisteriopsis caapi, Psychotria viridis, ayahuasca, ethnomedicine, N,N-dimethyltryptamine (DMT), harmine (HAR), harmaline, tetrahydroharmine

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy adults: men and women ages 25-65 years of age Previous experience with a psychedelic drug Vital Signs within normal limits for temperature (oral), respiratory rate, heart rate Normal blood pressure (for age) in the absence of antihypertensive drugs Normal complete blood count and differential, platelets, coagulation ((PT/PTT) Liver function tests ≤ 1.5X upper limits of normal Renal function (BUN, serum Creatinine) - within normal limits Able to understand and willing to comply with Study Protocol requirements. Willing to abstain from alcohol for at least 72 hours prior to and following Study Day 0 No use of recreational drugs for at least 14 days prior to Study Day 0. Women who are not pregnant or lactating. Exclusion Criteria (None can apply): Body Mass Index > 30 or < 20 Systemic condition that includes, but is not limited to: hematological, immunological, hepatic, renal, cardiac, neurological conditions that is under current treatment or causes abnormal physical or laboratory parameters. History of seizures History of drug or alcohol abuse History of psychiatric disorder or history of significant trauma, as defined by DSM- V. Use of SSRIs, MAO inhibitors, or other psychoactive compounds either pharmaceutical drugs or botanical in origin (i.e., 5-HTP, St John's Wort) Any condition which, in the opinion of the Investigators, would preclude the use of the test article or the successful completion of the study.

Sites / Locations

  • AIMS Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Open label Phase I safety & dose finding study: low dose group

Open label Phase I safety & dose finding study: medium dose group

Open label Phase I safety & dose finding study: high dose group

Arm Description

4 study participants will receive a low oral dose (0.5 mL/Kg) of SM-001

4 study participants will receive a medium oral dose (1.0 mL/Kg) of SM-001

4 study participants will receive a high oral dose (2.0 mL/Kg) of SM-001

Outcomes

Primary Outcome Measures

Primary Objective
To evaluate safety and tolerability of SM-001 in healthy adults following a single oral dose, at one of three different dose levels. The Incidence of Treatment-Emergent Adverse Events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE). Percentage of participants with at least one safety event [Time Frame: Baseline up to Day 28 ] Safety will be evaluated by the monitoring of adverse events (AEs), vital signs, blood pressure, heart rate, pulse oximetry, electrocardiogram (ECG) evaluations, clinical laboratory assessments and physical examination findings.

Secondary Outcome Measures

Short-term psychological impact
To assess short-term psychological impact of a single dose of SM-001 at three different dose levels in healthy adults by asking each study subject to complete a questionnaire called the Hallucinogenic Rating Scale 24 hours after the single experimental drug session. This is an 85 item questionnaire with each item rated 0-4 with a maximum score of 340. A higher score correlates with a more intense psychological experience.
Longer-term psychological impact
To assess longer-term psychological impact of a single dose of SM-001 at three different dose levels in healthy adults by asking each study subject to complete a questionnaire called the Persisting Effects Questionnaire 7 days following the single experimental drug session. The Persisting Effects Questionnaire includes 140 of the items that are rated on a 6-point scale (0=none, not at all; 1=so slight cannot decide; 2=slight; 3=moderate; 4=strong; 5=extreme, more than ever before in your life and stronger than 4).
Bioavailability of SM-001
To determine the blood, urine and feces levels of plant alkaloids including dimethyltryptamine, harmine, tetrahydroharmine and harmaline in ng/mL following a single oral dose of SM-001.
Effects of a single dose of SM-001 on blood levels of brain derived nerve growth factor
Brain Derived Neurotrophic Factor will be quantitated (ng/mL) is each study subject's blood on the day before and the day after the SM-001 drug session.
Effects of a single dose of SM-001 on blood cortisol blood levels
Cortisol levels in each study subject's blood will be measured (mg/mL)

Full Information

First Posted
March 15, 2023
Last Updated
July 5, 2023
Sponsor
Advanced Integrative Medical Science Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05894902
Brief Title
Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults
Official Title
Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Integrative Medical Science Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase I safety and dose finding study of a standardized Ayahuasca analog (SM-001) in healthy adult volunteers
Detailed Description
The Investigational New Drug SM-001 is formulated as a hot water decoction of two clonal cultivars of the Peruvian plants, Banisteriopsis caapi (BC) and Psychotria viridis (PV). It represents a modern formulation of an ancient Amazonian botanical medicine, "ayahuasca" ("vine of the soul") that is used by many native South American indigenous and mestizo groups for both religious and medicinal purposes. This initial Phase 1 study is to be conducted as an open label, dose-ranging safety assessment of a single dose of SM-001 taken orally by healthy adult volunteers. Twelve adult men and women, ages 25-65 years, will be consecutively assigned to one of three dose levels, 4 subjects per group (2 M; 2 F). In the presence of the Clinical Investigator(s), each subject will receive a single dose of SM-001, administered at the Clinical Study Site as a liquid at one of three dose levels: 0.25, 0.5, or1.5 ml SM-001 per kg body weight. To assess systemic exposure to SM-001, plasma levels of the four biomarkers, dimethyltryptamine, harmine, tetrahydroharmine, and harmaline will be measured. Blood samples will be drawn at baseline, HR 0 (pre-Study Drug dose), and then at HR 1, 2, 4, 8, and 24 post dose. Subjects will return to the Clinical Study Site at Study Day 28 for a final in-person assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Post Traumatic Stress Disorder
Keywords
Banisteriopsis caapi, Psychotria viridis, ayahuasca, ethnomedicine, N,N-dimethyltryptamine (DMT), harmine (HAR), harmaline, tetrahydroharmine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Subjects will be consecutively accrued to one of three study groups, starting at the lowest dose, Level 1 ("low" dose), and proceeding to the next higher dose level. Each subject will receive one dose of the Study Drug orally at the Clinical Study Site, according to their assigned dose Level. Dose levels vary by volume: Level 1: 0.5 mL/kg ("low"; 50% of usual dose) N=4 (2M/2F) Level 2: 1 ml/kg ("medium"; 100% of usual dose) N=4 (2M/2F) Level 3: 2 ml/kg ("high"; 200% of usual dose) N=4 (2M/2F)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open label Phase I safety & dose finding study: low dose group
Arm Type
Active Comparator
Arm Description
4 study participants will receive a low oral dose (0.5 mL/Kg) of SM-001
Arm Title
Open label Phase I safety & dose finding study: medium dose group
Arm Type
Active Comparator
Arm Description
4 study participants will receive a medium oral dose (1.0 mL/Kg) of SM-001
Arm Title
Open label Phase I safety & dose finding study: high dose group
Arm Type
Active Comparator
Arm Description
4 study participants will receive a high oral dose (2.0 mL/Kg) of SM-001
Intervention Type
Drug
Intervention Name(s)
SM-001
Other Intervention Name(s)
Ayahuasca
Intervention Description
The Investigational New Drug SM-001 is formulated as a hot water decoction of two proprietary clonal cultivars of the Peruvian plants, Banisteriopsis caapi (BC) and Psychotria viridis (PV).
Primary Outcome Measure Information:
Title
Primary Objective
Description
To evaluate safety and tolerability of SM-001 in healthy adults following a single oral dose, at one of three different dose levels. The Incidence of Treatment-Emergent Adverse Events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE). Percentage of participants with at least one safety event [Time Frame: Baseline up to Day 28 ] Safety will be evaluated by the monitoring of adverse events (AEs), vital signs, blood pressure, heart rate, pulse oximetry, electrocardiogram (ECG) evaluations, clinical laboratory assessments and physical examination findings.
Time Frame
1-28 days
Secondary Outcome Measure Information:
Title
Short-term psychological impact
Description
To assess short-term psychological impact of a single dose of SM-001 at three different dose levels in healthy adults by asking each study subject to complete a questionnaire called the Hallucinogenic Rating Scale 24 hours after the single experimental drug session. This is an 85 item questionnaire with each item rated 0-4 with a maximum score of 340. A higher score correlates with a more intense psychological experience.
Time Frame
24 hours after single drug session
Title
Longer-term psychological impact
Description
To assess longer-term psychological impact of a single dose of SM-001 at three different dose levels in healthy adults by asking each study subject to complete a questionnaire called the Persisting Effects Questionnaire 7 days following the single experimental drug session. The Persisting Effects Questionnaire includes 140 of the items that are rated on a 6-point scale (0=none, not at all; 1=so slight cannot decide; 2=slight; 3=moderate; 4=strong; 5=extreme, more than ever before in your life and stronger than 4).
Time Frame
Day 7 after a single drug session
Title
Bioavailability of SM-001
Description
To determine the blood, urine and feces levels of plant alkaloids including dimethyltryptamine, harmine, tetrahydroharmine and harmaline in ng/mL following a single oral dose of SM-001.
Time Frame
Day 1-2
Title
Effects of a single dose of SM-001 on blood levels of brain derived nerve growth factor
Description
Brain Derived Neurotrophic Factor will be quantitated (ng/mL) is each study subject's blood on the day before and the day after the SM-001 drug session.
Time Frame
Day 1-28
Title
Effects of a single dose of SM-001 on blood cortisol blood levels
Description
Cortisol levels in each study subject's blood will be measured (mg/mL)
Time Frame
Day 1 - 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults: men and women ages 25-65 years of age Previous experience with a psychedelic drug Vital Signs within normal limits for temperature (oral), respiratory rate, heart rate Normal blood pressure (for age) in the absence of antihypertensive drugs Normal complete blood count and differential, platelets, coagulation ((PT/PTT) Liver function tests ≤ 1.5X upper limits of normal Renal function (BUN, serum Creatinine) - within normal limits Able to understand and willing to comply with Study Protocol requirements. Willing to abstain from alcohol for at least 72 hours prior to and following Study Day 0 No use of recreational drugs for at least 14 days prior to Study Day 0. Women who are not pregnant or lactating. Exclusion Criteria (None can apply): Body Mass Index > 30 or < 20 Systemic condition that includes, but is not limited to: hematological, immunological, hepatic, renal, cardiac, neurological conditions that is under current treatment or causes abnormal physical or laboratory parameters. History of seizures History of drug or alcohol abuse History of psychiatric disorder or history of significant trauma, as defined by DSM- V. Use of SSRIs, MAO inhibitors, or other psychoactive compounds either pharmaceutical drugs or botanical in origin (i.e., 5-HTP, St John's Wort) Any condition which, in the opinion of the Investigators, would preclude the use of the test article or the successful completion of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leanna J Standish, ND PhD
Phone
2064201321
Email
Lstandish@aimsinstitute.net
First Name & Middle Initial & Last Name or Official Title & Degree
Sunil K Aggarwal, MD PhD
Phone
2064201321
Email
saggarwal@aimsinstitute.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leanna J Standish, ND PhD
Organizational Affiliation
AIMS Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
AIMS Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98102
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Speaks, MBA
Phone
206-420-1321
Email
mspeaks@aimsinstitute.net
First Name & Middle Initial & Last Name & Degree
Sunil K Aggarwal, MD, PhD
Phone
2064201321
Email
saggarwal@aimsinstitute.net
First Name & Middle Initial & Last Name & Degree
Leanna J Standish, ND PhD
First Name & Middle Initial & Last Name & Degree
Sunil K Aggarwal, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
903860
Citation
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.
Results Reference
background
PubMed Identifier
26442957
Citation
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.
Results Reference
background
PubMed Identifier
3284731
Citation
Brown CS, Bryant SG. Monoamine oxidase inhibitors: safety and efficacy issues. Drug Intell Clin Pharm. 1988 Mar;22(3):232-5. doi: 10.1177/106002808802200311.
Results Reference
background
PubMed Identifier
29366418
Citation
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.
Results Reference
background
PubMed Identifier
8889686
Citation
Callaway JC, Raymon LP, Hearn WL, McKenna DJ, Grob CS, Brito GS, Mash DC. Quantitation of N,N-dimethyltryptamine and harmala alkaloids in human plasma after oral dosing with ayahuasca. J Anal Toxicol. 1996 Oct;20(6):492-7. doi: 10.1093/jat/20.6.492.
Results Reference
background
PubMed Identifier
3283290
Citation
Da Prada M, Zurcher G, Wuthrich I, Haefely WE. On tyramine, food, beverages and the reversible MAO inhibitor moclobemide. J Neural Transm Suppl. 1988;26:31-56.
Results Reference
background
PubMed Identifier
23662333
Citation
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.
Results Reference
background
PubMed Identifier
21842159
Citation
Dos Santos RG, Grasa E, Valle M, Ballester MR, Bouso JC, Nomdedeu JF, Homs R, Barbanoj MJ, Riba J. Pharmacology of ayahuasca administered in two repeated doses. Psychopharmacology (Berl). 2012 Feb;219(4):1039-53. doi: 10.1007/s00213-011-2434-x. Epub 2011 Aug 13.
Results Reference
background
PubMed Identifier
17532158
Citation
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.
Results Reference
background
PubMed Identifier
26976063
Citation
Dominguez-Clave E, Soler J, Elices M, Pascual JC, Alvarez E, de la Fuente Revenga M, Friedlander P, Feilding A, Riba J. Ayahuasca: Pharmacology, neuroscience and therapeutic potential. Brain Res Bull. 2016 Sep;126(Pt 1):89-101. doi: 10.1016/j.brainresbull.2016.03.002. Epub 2016 Mar 11.
Results Reference
background
PubMed Identifier
17207120
Citation
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.
Results Reference
background
PubMed Identifier
820383
Citation
Gillin JC, Tinklenberg J, Stoff DM, Stillman R, Shortlidge JS, Wyatt RJ. 5-Methoxy-N,N-dimethyltryptamine: behavioral and toxicological effects in animals. Biol Psychiatry. 1976 Jun;11(3):355-8. No abstract available.
Results Reference
background
PubMed Identifier
18593735
Citation
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.
Results Reference
background
PubMed Identifier
8596116
Citation
Grob CS, McKenna DJ, Callaway JC, Brito GS, Neves ES, Oberlaender G, Saide OL, Labigalini E, Tacla C, Miranda CT, Strassman RJ, Boone KB. Human psychopharmacology of hoasca, a plant hallucinogen used in ritual context in Brazil. J Nerv Ment Dis. 1996 Feb;184(2):86-94. doi: 10.1097/00005053-199602000-00004.
Results Reference
background
PubMed Identifier
4997511
Citation
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.
Results Reference
background
PubMed Identifier
6387284
Citation
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.
Results Reference
background
PubMed Identifier
3839173
Citation
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.
Results Reference
background
PubMed Identifier
3525654
Citation
McCabe BJ. Dietary tyramine and other pressor amines in MAOI regimens: a review. J Am Diet Assoc. 1986 Aug;86(8):1059-64.
Results Reference
background
PubMed Identifier
16149337
Citation
McKenna DJ. Ayahuasca and human destiny. J Psychoactive Drugs. 2005 Jun;37(2):231-4. doi: 10.1080/02791072.2005.10399805.
Results Reference
background
PubMed Identifier
6587171
Citation
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.
Results Reference
background
PubMed Identifier
542010
Citation
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.
Results Reference
background
PubMed Identifier
8377927
Citation
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.
Results Reference
background
PubMed Identifier
20549682
Citation
Oliveira CD, Moreira CQ, de Sa LR, Spinosa Hde S, Yonamine M. Maternal and developmental toxicity of ayahuasca in Wistar rats. Birth Defects Res B Dev Reprod Toxicol. 2010 Jun;89(3):207-12. doi: 10.1002/bdrb.20244.
Results Reference
background
PubMed Identifier
25693169
Citation
Palhano-Fontes F, Andrade KC, Tofoli LF, Santos AC, Crippa JA, Hallak JE, Ribeiro S, de Araujo DB. The psychedelic state induced by ayahuasca modulates the activity and connectivity of the default mode network. PLoS One. 2015 Feb 18;10(2):e0118143. doi: 10.1371/journal.pone.0118143. eCollection 2015.
Results Reference
background
PubMed Identifier
26049017
Citation
Pic-Taylor A, da Motta LG, de Morais JA, Junior WM, Santos Ade F, Campos LA, Mortari MR, von Zuben MV, Caldas ED. Behavioural and neurotoxic effects of ayahuasca infusion (Banisteriopsis caapi and Psychotria viridis) in female Wistar rat. Behav Processes. 2015 Sep;118:102-10. doi: 10.1016/j.beproc.2015.05.004. Epub 2015 Jun 3.
Results Reference
background
PubMed Identifier
25714595
Citation
Pitol DL, Siessere S, Dos Santos RG, Rosa ML, Hallak JE, Scalize PH, Pereira BF, Iyomasa MM, Semprini M, Riba J, Regalo SC. Ayahuasca Alters Structural Parameters of the Rat Aorta. J Cardiovasc Pharmacol. 2015 Jul;66(1):58-62. doi: 10.1097/FJC.0000000000000243.
Results Reference
background
PubMed Identifier
22514127
Citation
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.
Results Reference
background
PubMed Identifier
11295326
Citation
Riba J, Rodriguez-Fornells A, Strassman RJ, Barbanoj MJ. Psychometric assessment of the Hallucinogen Rating Scale. Drug Alcohol Depend. 2001 May 1;62(3):215-23. doi: 10.1016/s0376-8716(00)00175-7.
Results Reference
background
PubMed Identifier
34658861
Citation
Kiraga MK, Mason NL, Uthaug MV, van Oorsouw KIM, Toennes SW, Ramaekers JG, Kuypers KPC. Persisting Effects of Ayahuasca on Empathy, Creative Thinking, Decentering, Personality, and Well-Being. Front Pharmacol. 2021 Oct 1;12:721537. doi: 10.3389/fphar.2021.721537. eCollection 2021.
Results Reference
background
PubMed Identifier
29664276
Citation
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.
Results Reference
background
PubMed Identifier
16356341
Citation
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.
Results Reference
background
PubMed Identifier
8297217
Citation
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.
Results Reference
background
PubMed Identifier
29682363
Citation
Bilhimer MH, Schult RF, Higgs KV, Wiegand TJ, Gorodetsky RM, Acquisto NM. Acute Intoxication following Dimethyltryptamine Ingestion. Case Rep Emerg Med. 2018 Feb 27;2018:3452691. doi: 10.1155/2018/3452691. eCollection 2018.
Results Reference
background
PubMed Identifier
372800
Citation
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.
Results Reference
background
PubMed Identifier
26165663
Citation
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.
Results Reference
background
PubMed Identifier
12361741
Citation
Yritia M, Riba J, Ortuno J, Ramirez A, Castillo A, Alfaro Y, de la Torre R, Barbanoj MJ. Determination of N,N-dimethyltryptamine and beta-carboline alkaloids in human plasma following oral administration of Ayahuasca. J Chromatogr B Analyt Technol Biomed Life Sci. 2002 Nov 5;779(2):271-81. doi: 10.1016/s1570-0232(02)00397-5.
Results Reference
background

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Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults

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