the dynamic field of psychedelic research: trials and …

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THE DYNAMIC FIELD OF PSYCHEDELIC RESEARCH: TRIALS AND PROJECTS

BY VICTOR CHIRUTA

Version 2.1

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FOREWORD

Mind Medicine Australia (MMA) is a charity that helps to alleviate the suffering caused by mental illness. This book

contains compiled tables of extrapolated information of current and past human studies. There is an immense amount

of human psychedelic studies, spanning over 70 years. As such, this document is by no means exhaustive and will be

continually updated. The psychedelics have been categorised in the following classes:

▪ PHENYLETHYLAMINES

MDMA (3,4-methylenedioxymethamphetamine; an ingredient sometimes present in ecstasy)

MDA (3,4-methylenedioxyamphetamine; an ingredient sometimes present in ecstasy)

Mescaline (main naturally occurring psychedelic in psychedelic cactus)

▪ INDOLE ALKALOIDS

Psilocybin (main naturally occurring psychedelic in psychedelic mushrooms)

Ibogaine (main naturally occurring psychedelic in iboga)

Ethocybin (synthetic homologue of psilocybin)

▪ ERGOLINES

LSD (lysergic acid diethylamide)

UML-491 (L-methyl-D-lysergic acid butanolamide bimaleate; methylated derivative of LSD)

LSA (d-lysergic amide; naturally occurring psychedelic in morning glory, fungi, and a precursor to

LSD)

▪ TRYPTAMINES

DMT (N,N-dimethyltryptamine; naturally occurring psychedelic in humans, animals, plants, and

fungi)

Ayahuasca (naturally occurring psychedelic of DMT administered with harmala alkaloids)

5-MeO-DMT (5-methoxy-dimethyltryptamine; main naturally occurring psychedelic in the psychedelic toad

Bufo alvarius)

DPT (N,N-dipropyltryptamine; synthetic homologue of DMT)

▪ OTHER PSYCHEDELICS

Salvinorin A (main naturally occurring psychedelic in Salvia divinorium)

Muscimol (main naturally occurring psychedelic in psychedelic Amanita spp. mushrooms)

Note: some indole alkaloids are tryptamines and visa versa. These psychedelic classes are listed purely for ease of

categorisation.

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TABLE OF CONTENTS

FOREWORD ....................................................................................................................................................................... 2

TABLE OF CONTENTS ........................................................................................................................................................ 3

HOW TO READ TRIALS AND PROJECTS TABLES ............................................................................................................... 4

PSYCHEDELIC TRIALS AND PROJECTS ............................................................................................................................... 6

PHENYLETHYLAMINES ....................................................................................................................................................... 7

MDMA Trials and Projects ........................................................................................................................................... 7

MDA Trials and Projects ............................................................................................................................................... 8

Mescaline Trials and Projects ...................................................................................................................................... 9

INDOLE ALKALOIDS......................................................................................................................................................... 10

Psilocybin Trials and Projects ..................................................................................................................................... 10

Ibogaine Trials and Projects ....................................................................................................................................... 12

Ethocybin Trials and Projects ..................................................................................................................................... 12

ERGOLINES ...................................................................................................................................................................... 13

LSD Trials and Projects ............................................................................................................................................... 13

UML-491 Trials and Projects ...................................................................................................................................... 14

LSA Trials and Projects ............................................................................................................................................... 14

TRYPTAMINES ................................................................................................................................................................. 15

DMT Trials and Projects ............................................................................................................................................. 15

Ayahuasca Trials and Projects.................................................................................................................................... 15

5-MeO-DMT Trials and Projects ................................................................................................................................. 16

DPT Trials and Projects ............................................................................................................................................... 16

OTHER PSYCHEDELICS .................................................................................................................................................... 17

Salvinorin A Trials and Projects ................................................................................................................................. 17

Muscimol Trials and Projects ..................................................................................................................................... 17

REFERENCES .................................................................................................................................................................... 18

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HOW TO READ TRIALS AND PROJECTS TABLES

Abbreviations used:

MDD Major Depressive Disorder

PTSD Post-Traumatic Stress Disorder

TRD Treatment-Resistant Depression

There are nine columns in the tables. The first column is the study design. The different categories and their meaning

are listed below:

• Phase 3 Efficacy testing in comorbidities and establishing adverse-effects.

• Phase 2 Further safety tests, efficacy testing and establishing a therapeutic dose.

• Phase 1 Safety and mechanism tests for a potential medicine.

• Early Phase 1 Feasibility testing for a potential medicine (also called Pilot Studies).

• Epidemiology Observational studies.

The second and third column refers to the study start year and end year. When the end year is listed as incomplete, it

means the study is either active and no longer recruiting, recruiting, or not yet recruiting. Withdrawn studies are not

included.

The fourth column ‘Outcome’ refers to why the researcher is conducting the study. You may follow the reference in

column nine to read more in-depth about the study outcomes. This document is not yet fully compiled, and some

clinical trials have not been assigned a hyperlink reference.

The fifth column ‘Effect’ dictates the outcome efficacy. For safety, mechanism, behavioural, and incomplete trials this

value is recorded as ‘n/a’.

The sixth column ‘Number of participants’, is how many people participated in a complete trial, or target participants

in an incomplete trial.

The seventh column ‘Placebo’ lets us know if the researchers used a placebo. There are three possible values:

• None No placebo was used.

• Random A placebo was used and randomly assigned to participants.

• Lead-in A placebo was used and allocated to certain participants.

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The eighth column ‘Masking’ tells us who involved in the study knew participants were getting either an active drug

or a placebo. There are five masking categories:

• Open-label No masking.

• Single Participants masked only.

• Double Participants and investigators masked.

• Triple Participants, investigators and either care provider or outcomes assessor

masked.

• Quadruple Participants, investigators, care provider, and outcomes assessor masked.

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PSYCHEDELIC TRIALS AND PROJECTS

This document provides details of clinical trials registered with a range of organisations around the globe. As tabulated

below, this document has retrieved clinical trials published on ClinicalTrials and ANZCTR, as well as scientific literature.

There are several other databases and more literature to evaluate. As such, this document is not exhaustive and will

be updated regularly. Below is a number summary of the evaluated trials in this document.

Psychedelic compound Number of complete trials Number of incomplete and

registered trials Number of observational

studies

MDMA 42 17 7

MDA 3 0 0

Mescaline 6 2 0

Psilocybin 11 55 2

Ethocybin 1 0 0

Ibogaine 1 2 0

LSD 37 10 0

UML-491 2 0 0

LSA 1 0 0

DMT 6 3 0

5-MeO-DMT 3 1 0

Ayahuasca 14 1 2

DPT 3 0 0

Salvinorin A 4 1 0

Muscimol 2 1 0

Total 136 93 11

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PHENYLETHYLAMINES

MDMA Trials and Projects

# Study design Year start Year end Location Sponsor Outcome Effect Number of participants

Placebo Masking Reference

1

Phase 3

2018 2021 United States, Multi-Site

Canada, Multi-Site Israel

MAPS PTSD Significant 100 Random Triple [1]

2 2021 Incomplete United States, Multi-Site

Canada, Quebec MAPS PTSD n/a 100 Random Open-label [2]

3 2020 Incomplete United States, Multi-Site Canada, British Columbia

Israel MAPS PTSD n/a 100 Random Triple [3]

4

Phase 2

2018 2019 Canada, Multi-Site MAPS PTSD Significant 4 None Open-label [4]

5 2017 2019 United States, Multi-Site MAPS PTSD Significant 38 None Open-label [5]

6 2016 2018 United States, South Carolina MAPS Relationship counselling where one person is

diagnosed with PTSD Significant 12 None Open-label [6]

7 2014 2017 United States, California MAPS Social anxiety in ASD Significant 12 Random Triple [7]

8 2014 2017 United States, South Carolina MAPS PTSD Significant 10 Random Triple [8]

9 2015 2018 United States, California MAPS Anxiety in life-threatening illness Significant 18 Random Quadruple [9, 10]

10 2013 2017 Israel MAPS PTSD Significant 10 Random Triple [11]

11 2012 2017 United States, Colorado MAPS PTSD Significant 29 Random Triple [12]

12 2011 2016 United States, South Carolina MAPS PTSD Significant 3 None Open-label [13]


14 2006 2011 Switzerland MAPS PTSD Significant 14 Random Triple [15]


16 2021 Incomplete United States MAPS PTSD n/a 20 None Open-label [17]

17 2021 Incomplete United States MAPS PTSD n/a 60 Random Open-label [18]

18 2021 Incomplete United States, California VA Loma Linda Health Care

System PTSD n/a 10 None Open-label [19]

19 2021 Incomplete United States, Multi-Site MAPS Eating disorder n/a 36 None Open-label [20]

20 2020 Incomplete

Czechia Germany

Netherlands Norway Portugal

United Kingdom

MAPS Europe B.V. PTSD n/a 40 None Open-label [21]

21 2019 Incomplete New Zealand University of Otago Depression and anxiety in cancer patients n/a 24 Random Quadruple [22]

22

Phase 1

2017 2020 United States, Georgia MAPS Safety and mechanism n/a 34 Random Double [23]

23 2016 2020 United States, Illinois University of Chicago Safety and mechanism n/a 40 Random Double [24]

24 2016 2018 United States, South Carolina MAPS Relationship counselling where one person is

diagnosed with PTSD Significant 12 None Open-label [6]

25 2014 2019 United States, Maryland John Hopkins University Safety and mechanism n/a 20 Random Triple [25]

26 2014 2014 Spain Parc de Salut Mar Safety and mechanism with mephedrone n/a 12 Random Double [26]

27 2013 2013 Switzerland University Hospital Basel Safety and mechanism n/a 16 Random Quadruple [27-29]

28 2011 2016 Switzerland University Hospital Basel Safety and mechanism with doxazosin n/a 16 Random Double [30]

29 2011 2013 Switzerland University Hospital Basel Safety and mechanism n/a 16 Random Quadruple [31]

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30 2010 2010 Switzerland University Hospital Basel Safety and mechanism with clonidine n/a 16 Random Double [32]

31 2009 2010 Switzerland University Hospital Basel Safety and mechanism with duloxetine n/a 16 Random Double [33]

32 2009 2010 Switzerland University Hospital Basel Safety and mechanism n/a 16 Random Double [34]

33 2004 2012 United States, Maryland National Institute on Drug Abuse Safety and mechanism n/a 187 Random Open-label [35]

34 2003 2011 Spain Parc de Salut Mar Safety and mechanism n/a 27 None Open-label [36]


36 1992 1996 Safety and mechanism n/a 6 None Open-label [38]

37 2022 Incomplete United States, Tennessee MAPS Safety and mechanism (hepatic function) n/a 16 None Open-label [39]

38 2021 Incomplete Switzerland University Hospital Basel Safety and mechanism n/a 24 Random Triple [40]

39 2021 Incomplete Switzerland University Hospital Basel Safety and mechanism n/a 24 Random Triple [41]

40 2021 Incomplete United States, Connecticut Yale University Safety and mechanism in PTSD n/a 20 Random Quadruple [42]

41 2021 Incomplete United States MAPS Safety and mechanism n/a 150 None Open-label [43]

42 2018 Incomplete United Kingdom Imperial College London Alcoholism n/a 20 None Open-label [44]

43 2011 Incomplete United States, Multi-Site MAPS Safety and mechanism n/a 100 Random Triple [45]

44

Early Phase 1

2019 2021 United States, Illinois University of Chicago Safety and mechanism in ASD n/a 24 Random Triple [46]


46 2014 2016 United States, Chicago University of Chicago Safety and mechanism n/a 84 Random Triple [48]

47 2013 2017 New Zealand The University of Auckland Tinnitus Significant 16 Random Quadruple [49]

48 2013 2014 Switzerland University Hospital Basel Safety and mechanism (fMRI) n/a 24 Random Quadruple [50]

49 2012 2013 Switzerland University Hospital Basel Safety and mechanism with methylphenidate n/a 30 Random Quadruple [51]

50 2011 2011 Switzerland University Hospital Basel Safety and mechanism with carvedilol n/a 16 Random Quadruple [28, 52, 53]

51 2010 2013 United States, Illinois University of Chicago Safety and mechanism n/a 65 Lead-in Double [54]

52 2010 2011 United States, California California Pacific Medical Center Safety and mechanism n/a 12 Random Quadruple [55]

53 2010 2010 Switzerland University Hospital Basel Safety and mechanism n/a 16 Random Double [28, 53, 56]

54 2009 2011 United States, California California Pacific Medical Center Safety and mechanism n/a 13 Random Double [57]

55 2006 2008 Switzerland University of Zurich Safety and mechanism n/a 50 Random Quadruple [58]

56 2021 Incomplete Switzerland University Hospital Basel Safety and mechanism in Diabetes insipidus n/a 30 Random Double [59]

57 2019 Incomplete Switzerland University Hospital Basel Fear extinction n/a 3 Random Quadruple [60]

58 Pre-Prohibition 1984 Safety and mechanism n/a 24 None Open-label [61]

59

Epidemiology

2015 2017 United States, California MAPS Safety and mechanism (fMRI) n/a 18 n/a n/a [62]

60 2010 2011 Netherlands Utrecht Institute for

Pharmaceutical Sciences Safety and mechanism in hangover n/a 39 n/a n/a [63]

61 2006 2011 Israel Hadassah Medical Organization Safety and mechanism (fMRI) n/a 18 n/a n/a [64]

62 2002 2005 Netherlands UMC Utrecht Safety and toxicity n/a 225 n/a n/a [65]

63 1988 1988 Safety and mechanism n/a 143 n/a n/a [66]

64 1986 1986 Safety and mechanism n/a n/a n/a [67]

65 2021 Incomplete Stanford University Safety and mechanism n/a 40 Random Open-label [68]

MDA Trials and Projects



1 Phase 1

2018 2018 Safety and mechanism n/a 12 Random Double [69]


3 Early Phase 1 2009 2009 United States, California California Pacific Medical Center Safety and mechanism n/a 12 Random Double [70, 71]

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Mescaline Trials and Projects



1

Phase 1

2014 2019 United States, Maryland John Hopkins University Safety and mechanism n/a 20 Random Triple [25]

2 2021 Incomplete Switzerland University Hospital, Basel Safety and mechanism n/a 16 Random Quadruple [72]


4

Pre-Prohibition

1967 Psychoneuroses and depression Significant 77 None Open-label [74]

5 1966 Psychoneuroses Significant 36 None Open-label [75]

6 1962 Psychoneuroses Significant 7 None Open-label [76]

7 1955 Germany [77]

8 1953 Germany [78]

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INDOLE ALKALOIDS

Psilocybin Trials and Projects



1

Phase 2

2019 2020 United Kingdom Imperial College London Major Depressive Disorder Significant 59 Random Double [79]

2 2017 2018 United States, Maryland John Hopkins University Major Depressive Disorder Significant 24 Random Single [80]

3 2017 2018 United States, Maryland John Hopkins University Safety and mechanism n/a 13 None Open-label [81]

4 2007 2016 United States, Maryland John Hopkins University Depression and anxiety in cancer patients Significant 56 Random Quadruple [82]

5 2021 Incomplete United States, Maryland Sheppard Pratt Health System Safety and mechanism in Bipolar 2 patients n/a 12 None Open-label [83]

6 2021 Incomplete United States, Oregon Portland VA Research Foundation, Inc Methamphetamine addiction n/a 30 Random Single [84]

7 2021 Incomplete United States, Massachusetts Yvan Beaussant Demoralisation in hospice patients n/a 15 None Open-label [85]

8 2021 Incomplete Jamaica Wake Network, Inc Microdosing for depression and anxiety n/a 120 Random Double [86]

9 2021 Incomplete United States, Maryland Sheppard Pratt Health System Treatment-Resistant Depression n/a 15 None Open-label [87]

10 2021 Incomplete Location not provided Northern Stockholm Psychiatry Major Depressive Disorder n/a 30 Random Quadruple [88]

11 2021 Incomplete United States, Maryland Johns Hopkins University Major Depressive Disorder in alcoholism n/a 90 Random Quadruple [89]

12 2021 Incomplete United Kingdom Imperial College London Anorexia nervosa n/a 20 None Open-label [90]

13 2021 Incomplete United States, California University of California, San Diego Anorexia nervosa n/a 20 None Open-label [91]

14 2021 Incomplete United States, New York New York State Psychiatric Institute Body Dysmorphic Disorders n/a 12 None Open-label [92]

15 2021 Incomplete Location not disclosed Ottawa Hospital Research Institute Depression and anxiety in end-of-life n/a 40 None Open-label [93]

16 2021 Incomplete United States, California Joshua Woolley, MD, PhD Depression and anxiety in Parkinson disease n/a 10 None Open-label [94]

17 2021 Incomplete United States, California Keith Heinzerling Alcohol dependence n/a 20 None Open-label [95]

18 2021 Incomplete Denmark Anders Fink-Jensen, MD, DMSci Alcohol dependence n/a 10 None Open-label [96]

19 2021 Incomplete Germany Central Institute of Mental Health,

Mannheim Treatment-Resistant Depression n/a 144 Random Triple [97]

20 2021 Incomplete Location not provided Beersheva Mental Health Center Obsessive Compulsive Disorder n/a 15 None Open-label [98]

21 2020 Incomplete Denmark Gitte Moos Knudsen Cluster headaches n/a 20 None Open-label [99]

22 2020 Incomplete United States, Maryland Maryland Oncology Hematology, PA Major Depressive Disorder in cancer n/a 30 None Open-label [100]

23 2020 Incomplete United Kingdom King's College London Major Depressive Disorder n/a 60 Random Quadruple [101]

24 2020 Incomplete United States, California

Ireland COMPASS Pathways Treatment-Resistant Depression n/a 20 None Open-label [102]

25 2020 Incomplete Switzerland University of Zurich Alcohol dependence n/a 60 Random Triple [103]

26 2019 Incomplete Switzerland University of Zurich Major Depressive Disorder n/a 60 Random Triple [104]

27 2019 Incomplete United States, Multi-Site Usona Institute Major Depressive Disorder n/a 100 Random Triple [105]

28 2019 Incomplete

United States, Multi-Site Canada, Ontario

Czechia Denmark Germany Ireland

Netherlands, Multi-Site Portugal

Spain, Multi-Site United Kingdom, Multi-Site

COMPASS Pathways Treatment-Resistant Depression n/a 216 Random Quadruple [106]

29 2018 Incomplete Finland University of Helsinki Severe depression n/a 60 Random Quadruple [107]

30 2014 Incomplete United States, Multi-Site NYU Langone Health Alcohol dependence n/a 135 Random Quadruple [108]

31 Phase 1b 2021 Incomplete United Kingdom Beckley Psytech Limited Unilateral neuralgiform headache attacks n/a 12 None Open-label [109]

32

Phase 1

2017 2018 United states, California Joshua Woolley Safety and mechanism in AIDS survivors n/a 20 None Open-label [110]


34 2014 2019 United States, Maryland John Hopkins University Safety and mechanism n/a 40 Random Double [111]

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35 2014 2015 United States, Wisconsin University of Wisconsin, Madison Safety and mechanism n/a 12 None Open-label [112]

36 2013 2014 United States, Maryland John Hopkins University Safety and mechanism n/a 10 None Open-label [113]

37 2021 Incomplete United States, Oregon Portland VA Research Foundation, Inc Methamphetamine addiction n/a 30 Random Single [84]

38 2021 Incomplete United States, Wisconsin University of Wisconsin, Madison Opioid addiction n/a 10 None Open-label [114]

39 2021 Incomplete Location not disclosed Ottawa Hospital Research Institute Depression and anxiety in end-of-life n/a 40 None Open-label [93]

40 2021 Incomplete United Kingdom Imperial College London Anorexia nervosa n/a 20 None Open-label [90]

41 2021 Incomplete United States, Minnesota University of Minnesota Safety and mechanism n/a 75 Random Triple [115]

42 2021 Incomplete United States, Wisconsin University of Wisconsin, Madison Safety and mechanism n/a 12 None Open-label [116]

43 2021 Incomplete United States, Connecticut Yale University Safety and mechanism in migraines n/a 24 Random Quadruple [117]

44 2021 Incomplete Location not provided Beersheva Mental Health Center Obsessive Compulsive Disorder n/a 15 None Open-label [98]

45 2020 Incomplete TRD in Type-2 Bipolar Disorder n/a 12 None Open-label

46 2020 Incomplete Denmark Gitte Moos Knudsen Cluster headaches n/a 20 None Open-label [99]


48 2019 Incomplete United States, Arizona University of Arizona Obsessive Compulsive Disorder n/a 15 Random Quadruple [118]

49 2019 Incomplete United States, Connecticut Yale University Concussion headaches n/a 24 Random Double [119]

50 2019 Incomplete United States, Maryland John Hopkins University Safety and mechanism in Anorexia nervosa n/a 18 None Open-label [120]

51 2019 Incomplete United States, Arizona University of Arizona Obsessive Compulsive Disorder n/a 15 Random Quadruple [118]

52 2018 Incomplete United States, Connecticut Yale University Obsessive Compulsive Disorder n/a 30 Random Quadruple [121]

53 2018 Incomplete United States, Connecticut Yale University Safety and mechanism in MDD n/a 18 Random Double [122]

54 2017 Incomplete Denmark Gitte Moos Knudsen Safety and mechanism n/a 45 Lead-in Single [123]

55 2017 Incomplete United States, Connecticut Yale University Safety and mechanism in migraines n/a 24 Random Double [124]

56 2016 Incomplete United States, Connecticut Yale University Cluster headaches n/a 24 Random Triple [125]

57 2015 Incomplete United States, New York NYU Langone Health Safety and mechanism n/a 12 None Open-label [126]

58 2015 Incomplete United States, Maryland John Hopkins University Psychology and Effectiveness of Professional

Leaders in Religion n/a 20 None Open-label [127]

59 2015 Incomplete United States, New York NYU Langone Health Psychology and Effectiveness of Professional

Leaders in Religion n/a 12 None Open-label [128]

60 2015 Incomplete United States, Alabama University of Alabama at Birmingham Cocaine addiction n/a 40 Random Quadruple [129]

61

Early Phase 1

2019 2021 Switzerland University Hospital, Basel Safety and mechanism n/a 28 Random Quadruple [130]

62 2009 2018 United States, New York NYU Langone Health Safety and mechanism in cancer patients n/a 29 Random Open-label [131]

63 2021 Incomplete United States, Maryland John Hopkins University Safety and mechanism in Alzheimer’s n/a 20 None Open-label [132]

64 2021 Incomplete United States, Utah University of Utah Safety and mechanism in cancer patients n/a 12 None Open-label [133]

65 2021 Incomplete United States, Missouri Washington University School of

Medicine Brain mapping and mechanism n/a 25 Random Single [134]

66 2008 Incomplete United States, Maryland John Hopkins University Smoking cessation n/a 95 None Open-label [135]

67

Epidemiology

2020 Incomplete United States, Florida Usona Institute Follow-up in Major Depressive Disorder n/a 80 n/a n/a [136]

68 2020 Incomplete

United States, Multi-Site Canada, Ontario

Czechia Denmark Germany Ireland

Netherlands, Multi-Site Portugal

Spain, Multi-Site United Kingdom, Multi-Site

COMPASS Pathways Follow-up in Treatment-Resistant Depression n/a 150 n/a n/a [137]

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Ibogaine Trials and Projects



1 Phase 3 2017 Incomplete Cocaine/crack-addiction n/a 70 None Open-label [138]

2

Phase 2

2021 Incomplete Brazil University of Sao Paulo Alcoholism n/a 12 Random Quadruple [139]

3 2020 Incomplete Spain International Center for

Ethnobotanical Education Opioid-addiction n/a 20 Random Quadruple [140]

4 Phase 1 2013 2013 New Zealand University of Otago Safety and mechanism n/a 21 Random Quadruple [141]

Ethocybin Trials and Projects



1 Phase 1 2014 2019 United States, Merrylands John Hopkins University Safety and behavioural n/a 20 Random Triple [25]

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ERGOLINES

LSD Trials and Projects



1

Phase 2

2008 2012 Switzerland MAPS Anxiety Significant 12 Random Quadruple [142]

2 2019 Incomplete Switzerland University Hospital, Basel Depression n/a 60 Random Quadruple [143]

3 2019 Incomplete Switzerland University Hospital, Basel Cluster headaches n/a 30 Random Quadruple [144]

4 2017 Incomplete Switzerland University Hospital, Basel Anxiety n/a 40 Random Quadruple [145]

5

Phase 1

2015 2015 United States Eleusis Therapeutics Safety and mechanism for microdose n/a 48 Random Quadruple [146]

6 2014 2019 United States, Merrylands John Hopkins University Safety and behavioural n/a 20 Random Triple [25]

7 2021 Incomplete New Zealand University of Auckland Safety and mechanism for microdose n/a 80 Random Triple [147]

8 2021 Incomplete Switzerland University Hospital, Basel Safety and mechanism n/a 24 Random Triple [40]


10 2020 Incomplete United States, Illinois University of Chicago Safety and mechanism for microdose n/a 60 Lead-in Double [149]



13 2018 Incomplete United States, Illinois University of Chicago Safety and mechanism n/a 40 Random Triple [151]

14

Early Phase 1

2019 2021 Switzerland University Hospital, Basel Safety and mechanism n/a 28 Random Quadruple [130]

15 2017 2018 Switzerland University Hospital, Basel Safety and mechanism n/a 28 Random Quadruple [47]

16 2015 2016 Switzerland Psychiatric University Hospital, Zurich Safety and mechanism n/a 25 Lead-in Double [152]

17 2013 2014 Switzerland University Hospital, Basel Safety and mechanism n/a 16 Lead-in Quadruple [153]

18

Pre-Prohibition

Published 1973 Severe psychoneuroses Significant 63 None Open-label [154]

19 1973 United States, Wisconsin Winnebago State Hospital Autistic and schizophrenic children Moderate 57 None Open-label [155]

20 Published 1968 United Kingdom Depression Significant 36 None Open-label [74]

21 Published 1967 Depression Significant 11 None Open-label [156]

22 1967 United States, North Carolina [157]

23 Published 1966 Psychoneuroses Significant 77 None Open-label [75]

24 1965 France [158]

25 Published 1964 Canada Depression Significant 11 None Open-label [159]

26 Published 1964 Australia Depression Significant 21 None Open-label [160]

27 Published 1964 United Kingdom Depression and anxiety Significant 28 None Open-label [161]

28 Published 1964 Severe psychoneuroses Significant 60 None Open-label [162]

29 1963 United Kingdom [163]


31 1963 United States, New York Creedmoor Psychiatric Center Autistic and schizophrenic children Moderate 50 None Open-label [164]


33 1962 United States, New York League School Autistic and schizophrenic children Moderate 12 None Open-label [166]

34 Published 1961 Depression and anxiety Significant 25 None Open-label [167]

35 1961 Germany [168]




39 Published 1957 Psychoneuroses, depression, and anxiety Significant 35 None Open-label [172]



42 1955 1956 United States, New Jersey Macy Foundation Autistic children Significant 3 None Open-label [175]


44 Published 1954 Psychoneurosis and depression Significant 30 None Open-label [177]

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UML-491 Trials and Projects



1 Pre-Prohibition

1963 United States, New York Creedmoor Psychiatric Center Autistic and schizophrenic children Moderate 50 None Open-label [164]


LSA Trials and Projects



1 Phase 1 2014 2019 United States, Merrylands John Hopkins University Safety and behavioural n/a 20 Random Triple [25]

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TRYPTAMINES

DMT Trials and Projects



1 Phase 2 2021 Incomplete United Kingdom Small Pharma Ltd Depression n/a 68 Random Quadruple [181]

2

Phase 1

2019 United Kingdom Imperial College London Safety and mechanism (EEG) n/a 13 Lead-in Open-label [182]

3 2014 2019 United States, Merrylands John Hopkins University Safety and behavioural n/a 20 Random Triple [25]

4 2015 Safety and mechanism (QEEG) n/a 13 None Open-label [183]





9 2021 Incomplete United States, Connecticut Yale University Depression n/a 6 None Open-label [188]

Ayahuasca Trials and Projects



1 Phase 2

2014 2016 Brazil Universidade Federal do Rio Grande do Norte Depression Significant 38 Random Triple [189, 190]

2 2015 Brazil Universidade de São Paulo Major Depressive Disorder Significant 6 None Open-label [191]

3

Phase 1

2012 Safety and mechanism n/a 10 None Open-label [192]

4 2011 Spain Spanish Ministry of Health Safety and mechanism n/a 9 Random Double [193]

5 2004 Safety and mechanism (EEG) n/a 18 Random Double [194]

6 2002 Safety and mechanism (EEG) n/a 18 Random Double [195]


8 1998 Brazil Safety and mechanism (EEG) n/a 11 None Open-label [197]

9 2001 Safety and mechanism n/a 6 Random Single [198]

10

Early Phase 1

2018 Mindfulness Significant 20 None Open-label [199]

11 2015 Safety and mechanism (fMRI) n/a 10 None Open-label [200]

12 1999 Brazil Instituto Nacional de Pesquisas da Amazônia Safety and mechanism n/a 15 None Open-label [201]

13 1996 Brazil Safety and mechanism n/a 15 None Open-label [202]

14 1993 Brazil Safety and mechanism n/a 30 Lead-in Open-label [203]

15 2020 Incomplete Switzerland Psychiatric University Hospital, Zurich Safety and mechanism n/a 30 Random Quadruple [204]

16 Epidemiology

2015 Mechanism Significant 36 n/a n/a [205]

17 2020 Incomplete Safety and mechanism n/a 25 n/a n/a [206]

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5-MeO-DMT Trials and Projects



1 Phase 2 2019 Incomplete Netherlands GH Research Limited Depression n/a 16 None Open-label [207]

2 Phase 1

2019 2019 Netherlands GH Research Limited Safety and mechanism n/a 22 None Open-label [208]

3 2015 Safety and mechanism (QEEG) n/a 13 None Open-label [183]

DPT Trials and Projects



1 Phase 1 2014 2019 United States, Maryland John Hopkins University Safety and behavioural n/a 20 Random Triple [25]

2 Pre-Prohibition

1975 1975 Alcohol dependence Significant 51 None Open-label [209]

3 1973 1973 Alcohol dependence Significant 16 Random Double [210]

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OTHER PSYCHEDELICS

Salvinorin A Trials and Projects



1

Phase 1

2017 2020 United States, Meryland John Hopkins University Safety and mechanism n/a 13 None Open-label [211]

2 2014 2019 United States, Meryland John Hopkins University Safety and behavioural n/a 20 Random Triple [25]

3 2010 2010 Safety and mechanism n/a 4 None Open-label [212]

4 2008 2013 United States, Meryland John Hopkins University Safety and mechanism n/a 14 None Triple [213]

5 2009 Incomplete United States, Connecticut Yale University Safety and mechanism n/a 41 Random Quadruple [214]

Muscimol Trials and Projects



1

Phase 1

2000 2014 United States, Maryland National Institute of Neurological

Disorders and Stroke Safety and mechanism in epilepsy n/a 3 None Open-label [215, 216]

2 2009 Withdrawn United States, Maryland National Institute of Neurological

Disorders and Stroke Safety and mechanism in Parkinson’s Disease n/a 0 None Open-label [217]

3 Pre-Prohibition 1977 Huntington’s Disease Minimal 10 Rando Double [218, 219]

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REFERENCES

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2. NIH. A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD (MAPPUSX), 2021. https://clinicaltrials.gov/ct2/show/NCT04714359 (accessed).

3. NIH, A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD. 2020. 4. NIH. Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD,

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Member Has Chronic PTSD, 2016. https://clinicaltrials.gov/ct2/show/NCT02876172 (accessed).

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