Psychedelic Commercialization: A Wide-Spanning Overview of the Emerging Psychedelic Industry

Abstract

Background:

In the wake of positive clinical trial outcomes of psychedelic-assisted psychotherapy for the treatment of various psychiatric disorders, there has been an influx of financial investment into psychedelic drug development from the pharmaceutical and biotech sectors. Psychedelics are now a multibillion dollar industry, with hundreds of companies that are seeking to commercialize therapeutic applications of psychedelics formed over the course of just a few years.

Materials and Methods:

This paper aims to provide a broad overview of the psychedelic industry by detailing the history and current state of psychedelic drug commercialization, exploring challenges to commercial viability, highlighting ethical considerations, and incorporating lessons from the analogous ketamine and cannabis industries, which largely preceded the psychedelic industry.

Results:

We found that although the roots of the psychedelic industry go back decades, financial investment did not take off in earnest until the late 2010s and early 2020s. The main focus of companies in the psychedelic sector can be broadly grouped into: (1) drug discovery and development; (2) novel formulations and routes of administration; (3) manufacturing and synthesis; (4) treatment centers and wellness clinics; (5) consumer packaged goods and adult use; and (6) adjunct technologies. Challenges to commercial viability include regulatory barriers to drug development, treatment costs and logistics of administration, and intellectual property and patent issues. In terms of ethics, the industry must consider the potential adverse effects of psychedelics, cost-cutting inclinations, ensuring therapeutic benefits reach vulnerable and marginalized communities, and indigenous reciprocity. We also underscore the potential benefits commercialization may bring. Lastly, the ketamine and cannabis industries can provide blueprints for regulatory approval, clinical implementation, insurance reimbursement, and federal policy more broadly.

Conclusion:

Altogether, this article provides a wide-spanning overview of the emerging commercialization of psychedelics, acknowledging both the monumental progress and critical challenges that remain for the industry.

Get full access to this article

View all access options for this article.

References

Aday

, Mitzkovitz

, Bloesch

, et al. Long-term effects of psychedelic drugs: A systematic review. Neurosci Biobehav Rev, 2020; 113:179–189.

Phelps

, Shah

, Lieberman

. The rapid rise in investment in psychedelics—Cart before the horse. JAMA Psychiatry, 2022; 79(3):189–190.

Psychedelic therapeutics market worth $ 8.31 billion by 2028—Exclusive report by Insightace Analytic [Internet]. Bloomberg; 2022 [cited 2023 May 16]. Available from: https://www.bloomberg.com/press-releases/2022-07-18/psychedelic-therapeutics-market-worth-8-31-billion-by-2028-exclusive-report-by-insightace-analytic [Last accessed: May 16, 2023].

Johnson

, Richards

, Griffiths

. Human hallucinogen research: Guidelines for safety. J Psychopharmacol, 2008; 22(6):603–620.

Ross

, Bossis

, Guss

, et al. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: A randomized controlled trial. J Psychopharmacol, 2016; 30(12):1165–1180.

Griffiths

, Johnson

, Carducci

, et al. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol, 2016; 30(12):1181–1197.

Aday

, Heifets

, Pratscher

, et al. Great Expectations: Recommendations for improving the methodological rigor of psychedelic clinical trials. Psychopharmacology, 2022; 239(6):1989–2020.

Olson

DE.

Psychoplastogens: A promising class of plasticity-promoting neurotherapeutics. J Exp Neurosci, 2018; 12:1179069518800508.

Carhart-Harris

, Giribaldi

, Watts

, et al. Trial of psilocybin versus escitalopram for depression. N Engl J Med, 2021; 384(15):1402–1411.

10.

Grob

, Danforth

, Chopra

, et al. Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer. Arch Gen Psychiatry, 2011; 68(1):71–78.

11.

Bogenschutz

, Ross

, Bhatt

, et al. Percentage of heavy drinking days following Psilocybin-Assisted psychotherapy vs placebo in the treatment of adult patients with alcohol use disorder: A randomized clinical trial. JAMA Psychiatry, 2022; 79(10):953–962.

12.

Agin-Liebes

, Malone

, Yalch

, et al. Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer. J Psychopharmacol, 2020; 34(2):155–166.

13.

Moreno

, Wiegand

, Taitano

, et al. Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder. J Clin Psychiatry, 2006; 67(11):1735–1740.

14.

Mitchell

, Bogenschutz

, Lilienstein

, et al. MDMA-assisted therapy for severe PTSD: A randomized, double-blind, placebo-controlled phase 3 study. Nat Med, 2021; 27(6):1025–1033.

15.

Bernschneider-Reif

, Oxler

, Freudenmann

. The origin of MDMA (“ecstasy”)—separating the facts from the myth. Pharmazie, 2006; 61(11):966–972.

16.

Benzenhöfer

, Passie

. Zur Frühgeschichte von “Ecstasy” [The early history of “Ecstasy”]. Nervenarzt, 2006; 77(1):95–96, 98–99.

17.

Jay

100 years of mescaline. Monatsh Chem, 2019; 150:957–959; doi: 10.1007/s00706-019-02425-3

18.

Pope

HG.

Tabernanthe iboga: An African Narcotic Plant of social importance. Econ Bot, 1969; 23(2):174–184.

19.

Lavaud

, Massiot

The Iboga alkaloids. In: Progress in the Chemistry of Organic Natural Products. ( Kinghorn

, Falk

, Gibbons

, Kobayashi

. eds.) Springer: Berlin, Germany; 2017; p. 126.

20.

Nestor

An Anti-Addiction Drug Called Ibogaine Could Be a Wonder Cure—Or an Addict Killer. Scientific American. November 1, 2016. https://www.scientificamerican.com/article/an-anti-addiction-drug-called-ibogaine-could-be-a-wonder-cure-or-an-addict-killer [Last accessed: April 27, 2023].

21.

Hintzen

, Passie

The Pharmacology of LSD. Oxford University Press: Oxford, United Kingdom; 2010

22.

Bonson

KR.

Regulation of human research with LSD in the United States (1949–1987). Psychopharmacology, 2018; 235:591–604.

23.

Grof

Stanislav Grof interviews Dr. Albert Hofmann. Multidisciplinary Association for Psychedelic Studies Bulletin XI (2). 2001. Available from: https://maps.org/news-letters/v11n2/11222gro.pdf [Last accessed: April 28, 2023].

24.

Psychedelic Science Review. Sandoz Parmaceutical Begins Selling Psilocybin Under the Trade Name Indocybin. 2023. Available from: https://psychedelicreview.com/event/sandoz-parmaceutical-manufactures-indocybin [Last accessed: April 27, 2023].

25.

Johnson

, Griffiths

, Hendricks

, et al. The abuse potential of medical psilocybin according to the 8 factors of the Controlled Substances Act. Neuropharmacology, 2018; 142:143–166; doi: 10.1016/j.neuropharm.2018.05.012

26.

Google Patents. Obtaining psilocybin and psilocin from fungal material. 2023. https://patents.google.com/patent/US3183172A/en [Last accessed: April 27, 2023].

27.

Emerson

, Ponté

, Jerome

, et al. History and future of the Multidisciplinary Association for Psychedelic Studies (MAPS). J Psychoactive Drugs, 2014; 46(1):27–36; doi: 10.1080/02791072.2014.877321

28.

Mithoefer

, Wagner

, Mithoefer

, et al. The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: The first randomized controlled pilot study. J Psychopharmacol, 2011; 25(4):439–452; doi: 10.1177/0269881110378371. Epub July 19, 2010. Erratum in: J Psychopharmacol 2011;25:852.

29.

Doblin. Introducing the MAPS Public Benefit Corporation. 2015. Available from: https://maps.org/news/bulletin/introducing-the-maps-public-benefit-corporation [Last accessed: November 23, 2022].

30.

Mithoefer

, Feduccia

, Jerome

, et al. MDMA-assisted psychotherapy for treatment of PTSD: Study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials. Psychopharmacology, 2019; 236:2735–2745.

31.

Multidisciplinary Association for Psychedelic Studies. Second MAPS-Sponsored Phase 3 Trial of MDMA-Assisted Therapy for PTSD Completed. 2022. Available from: https://maps.org/2022/11/17/mapp2-second-maps-sponsored-phase-3-trial-of-mdma-assisted-therapy-for-ptsd-completed [Last accessed: November 23, 2022].

32.

Multidisciplinary Association for Psychedelic Studies. Prior Positive Results Confirmed in MAPS-Sponsored, Philanthropy-Funded Phase 3 Trial. 2023. Available from: https://maps.org/2023/01/05/prior-positive-results-confirmed [Last accessed: February 8, 2023].

33.

Barnett

, Parker

, Weleff

. United States National Institutes of Health grant funding for psychedelic-assisted therapy clinical trials from 2006–2020. Int J Drug Policy, 2022; 99:103473; doi: 10.1016/j.drugpo.2021.103473

34.

Johns Hopkins Medicine. Johns Hopkins Medicine Receives First Federal Grant for Psychedelic Treatment Research in 50 years. 2021. Available from: https://www.hopkinsmedicine.org/news/newsroom/news-releases/johns-hopkins-medicine-receives-first-federal-grant-for-psychedelic-treatment-research-in-50-years [Last accessed: November 23, 2022].

35.

Psychedelic Alpha. Psychedelic Funding in 2022. Psychedelic Alpha. December 31, 2022. Available from: https://psychedelicalpha.com/news/psychedelic-funding-in-2022 [Last accessed: April 30, 2023].

36.

Schuster-Bruce

, Lee

. Meet the top 14 VCs who've bet the most cash on turning psychedelics into medical treatments. Business Insider. March 16, 2023. Available from: https://www.businessinsider.com/list-top-venture-capital-investors-psychedelics-industry-2023 [Last accessed: April 30, 2023].

37.

Donovan

, Johansen

, Ros

, et al. Effects of a single dose of psilocybin on behaviour, brain 5-HT2A receptor occupancy and gene expression in the pig. Eur Neuropsychopharmacol, 2021; 42:1–11; doi: 10.1016/j.euroneuro.2020.11.013

38.

Siebert

Big Pharma in Psychedelics: Inside Mindset Pharma's Deal with Otsuka. Forbes. February 10, 2022. Available from: https://www.forbes.com/sites/amandasiebert/2022/02/10/big-pharma-in-psychedelics-inside-mindset-pharmas-deal-with-otsuka/?sh=16e786ca2abe [Last accessed: April 30, 2023].

39.

Atai Life Sciences. Atai Life Sciences Announces Results from Phase 2a Trial of PCN-101 (R-ketamine) for Treatment-Resistant Depression. January 6, 2023. Available from: https://ir.atai.life/news-releases/news-release-details/atai-life-sciences-announces-results-phase-2a-trial-pcn-101-r [Last accessed: May 1, 2023].

40.

Fadahunsi

, Lund

, Breum

, et al. Acute and long-term effects of psilocybin on energy balance and feeding behavior in mice. Transl Psychiatry, 2022; 12(1):330; doi: 10.1038/s41398-022-02103-9

41.

Two tandem projects between NRU and Univ. CPH funded by the Novo Nordisk Foundation. May 8, 2023. Available from: https://www.nru.dk/index.php/news-menu/429-two-tandem-projects-between-nru-and-univ-cph-funded-by-the-novo-nordisk-foundation [Last accessed: May 13, 2023].

42.

Psychedelic alpha. Psychedelic Stocks & Companies. 2023. Available from: https://psychedelicalpha.com/psilocybin-stocks-shroom-stocks [Last accessed: May 4, 2023].

43.

Reuters. Thiel-backed psychedelics startup Atai valued at $3.19 bln in Nasdaq debut. 2021. Available from: https://www.reuters.com/business/thiel-backed-psychedelics-firm-atai-valued-319-bln-nasdaq-debut-2021-06-18 [Last accessed: November 23, 2022].

44.

Brodwin

Peter Thiel is betting on magic mushrooms to treat depression—And he's not the only one. 2017. Available from: https://www.businessinsider.com/peter-thiel-magic-mushrooms-psychedelics-depression-science-2017-12 [Last accessed: November 23, 2022].

45.

Waldron

2 months after depression fail, Atai lays off 30% and reviews pipeline again. Fierce Biotech. Available from: https://www.fiercebiotech.com/biotech/2-months-after-depression-fail-atai-lays-30-and-reviews-pipeline-again [Last accessed: May 1, 2023].

46.

Compass Pathways. COMPASS Pathways receives FDA Breakthrough Therapy designation for psilocybin therapy for treatment-resistant depression. 2018. https://compasspathways.com/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression [Last accessed: November 23, 2022].

47.

Goldhill

A millionaire couple is threatening to create a magic mushroom monopoly. 2018. Available from: https://qz.com/1454785/a-millionaire-couple-is-threatening-to-create-a-magic-mushroom-monopoly [Last accessed: November 23, 2022].

48.

Peters

First Psychedelic Drug Stock Hits $1 Billion in Debut After Upsized IPO. 2020. Available from: https://www.investors.com/news/compass-pathways-sees-544-million-valuation-first-psychedelic-drugs-ipo [Last accessed: November 23, 2022].

49.

Borchardt

Compass Pathways Only Has Enough Money for One Year. Green Market Report. 2023. Available from: https://www.greenmarketreport.com/compass-pathways-only-has-enough-money-for-one-year [Last accessed: May 15, 2023].

50.

Ingham

GH Research: Can ‘Toad Venom’ Cure Depression? This Company Thinks It Can. Seeking Alpha. March 10, 2023. Available from: https://seekingalpha.com/article/4586519-gh-research-cure-depression-psychedelics [Last accessed: April 28, 2023].

51.

Frankel

Mind Medicine: Why Kevin O'Leary Thinks This Psychedelics Company Is Just Getting Started. 2021. Available from: https://www.fool.com/investing/2021/01/06/mind-medicine-why-kevin-oleary-thinks-this-psyched [Last accessed: November 23, 2022].

52.

Businesswire. MindMed Lists on NEO to Become World's First Psychedelic Pharmaceutical Company to Go Public. 2020. Available from: https://www.businesswire.com/news/home/20200303005344/en/MindMed-Lists-on-NEO-to-Become-World%E2%80%99s-First-Psychedelic-Pharmaceutical-Company-to-Go-Public [Last accessed: November 23, 2022].

53.

Yakowicz

Psychedelics Company MindMed Trips In Nasdaq Debut. 2021. Available from: https://www.forbes.com/sites/willyakowicz/2021/04/27/psychedelics-company-mindmed-trips-in-nasdaq-debut/?sh=3610d65b1ac2 [Last accessed: November 23, 2022].

54.

Hallifax

MindMed Shelves 18-MC for Opioid Use Disorder and Further Cuts Pipeline. 2022. Available from: https://psychedelicspotlight.com/mindmed-shelves-18-mc-for-opioid-use-disorder-and-further-cuts-pipeline [Last accessed: November 23, 2022].

55.

MindMed. MindMed Announces First Patient Dosed in Phase 2b Trial of MM-120 in Generalized Anxiety Disorder. Available from: https://mindmed.co/news/press-release/mindmed-announces-first-patient-dosed-in-phase-2b-trial-of-mm-120-in-generalized-anxiety-disorder [Last accessed: November 23, 2022].

56.

Holze

, Gasser

, Müller

, et al. Lysergic acid diethylamide-assisted therapy in patients with anxiety with and without a life-threatening illness: A randomized, double-blind, placebo-controlled phase II study. Biol Psychiatry, 2023; 93(3):215–223.

57.

Buntz

MindMed announces Phase 1 study of MDMA-like substances. Drug Discovery & Development. September 21, 2022. Available from: https://www.drugdiscoverytrends.com/mindmed-announces-phase-1-study-of-mdma-like-substances [Last accessed May 1, 2023].

58.

Psychedelic alpha. Psychedelic Bulletin #108—COMPASS Survives Patent Challenges; MindMed Secures Candyflipping IP; Will Psychedelics Companies Protect Access to Abortion for Employees? June 27, 2022. Available from: https://psychedelicalpha.com/news/psychedelic-bulletin-108-compass-survives-patent-challenges-mindmed-secures-candyflipping-ip-will-psychedelics-companies-protect-access-to-abortion-for-employees [Last accessed: May 4, 2023].

59.

Businesswire. FDA grants Breakthrough Therapy Designation to Usona Institute's psilocybin program for major depressive disorder. 2019. Available from: https://www.businesswire.com/news/home/20191122005452/en/FDA-grants-Breakthrough-Therapy-Designation-to-Usona-Institutes-psilocybin-program-for-major-depressive-disorder [Last accessed: November 23, 2022].

60.

Biotech Valley Insights. Compass Pathways: An Overvalued Psychedelic Company with a Single Mediocre Drug. 2020. Available from: https://seekingalpha.com/article/4390988-compass-pathways-overvalued-psychedelic-company-single-mediocre-drug [Last accessed: November 23, 2022].

61.

Tobin

MindMed: Confusing MEME Rally Hides a Company That Looks Empty of Value. 2022. Available from: https://seekingalpha.com/article/4538887-mindmed-a-confusing-meme-rally-hides-a-company-that-looks-empty-of-value [Last accessed: November 23, 2022].

62.

Ingham

. Compass Pathways: De-Risked (But Still Risky) Psychedelics Play Enters Phase 3. Available from: https://seekingalpha.com/article/4549513-compass-pathways-de-risked-but-still-risky-psychedelics-play-enters-phase-3. 2022 [Last accessed: November 23, 2022].

63.

Carhart-Harris

, Bolstridge

, Rucker

, et al. Psilocybin with psychological support for treatment-resistant depression: An open-label feasibility study. Lancet Psychiatry, 2016; 3(7):619–627.

64.

Goodwin

, Aaronson

, Alvarez

, et al. Single-dose psilocybin for a treatment-resistant episode of major depression. N Engl J Med, 2022; 387(18):1637–1648.

65.

Hallifax

Can Psychedelic Stocks Like MindMed and Atai Ever Recover?. 2022. Available from: https://microdose.buzz/news/can-psychedelic-stocks-like-mindmed-and-atai-ever-recover [Last accessed: November 23, 2022].

66.

Taylor

Consolidation in psychedelics starts as Beckley and Eleusis combine. Pharmaphorum. 2022. Available from: https://pharmaphorum.com/news/consolidation-in-psychedelics-starts-as-beckley-and-eleusis-combine [Last accessed: December 15, 2022].

67.

GH Research. GH Research Announces Successful Outcome of the Phase 2 part of its Phase 1/2 Clinical Trial of GH001 in Treatment-Resistant Depression. 2021. Available from: https://www.globenewswire.com/en/news-release/2021/12/06/2346425/0/en/GH-Research-Announces-Successful-Outcome-of-the-Phase-2-part-of-its-Phase-1-2-Clinical-Trial-of-GH001-in-Treatment-Resistant-Depression.html [Last accessed: November 23, 2022].

68.

Compass Pathways. COMPASS Pathways Announces Third Quarter 2022 Financial Results and Business Highlights. 2022. Available from: https://compasspathways.com/compass-pathways-announces-third-quarter-2022-financial-results-and-business-highlights [Last accessed: November 23, 2022].

69.

Pollack

Psychedelics researchers and investors should focus on delivering therapy, not drugs. 2022. Available from: https://www.statnews.com/2022/08/12/psychedelics-researchers-investors-focus-on-therapy-not-drugs [Last accessed: November 23, 2022].

70.

Larson

Psychedelics Startup Field Trip Health Seeks Buyer to Stay Afloat During Reorganization. Behavioral Health Business. March 23, 2023. Available from: https://bhbusiness.com/2023/03/23/psychedelics-startup-field-trip-health-seeks-buyer-to-stay-afloat-during-reorganization [Last accessed: May 16, 2023].

71.

Goldstein

Former Field Trip Health, Now Reunion Neuroscience: Q1 2023 Financial Results & Corporate Reorganization. Benzinga. Available from: https://www.benzinga.com/markets/cannabis/22/08/28525506/former-field-trip-health-is-now-reunion-neuroscience-this-is-how-its-q1-2023-financial-results-c [Last accessed: May 11, 2023].

72.

Jaeger

DEA Proposes Even Higher 2023 Production Quotas for Psychedelics Like MDMA And Psilocyn. 2022. Available from: https://www.marijuanamoment.net/dea-proposes-even-higher-2023-production-quotas-for-psychedelics-like-mdma-and-psilocyn [Last accessed: December 9, 2022].

73.

Jaeger

Top Federal Health Official Touts Psychedelics' Therapeutic Benefits and Slams Marijuana Scheduling. Marijuana Moment. 2021. Available from: https://www.marijuanamoment.net/top-federal-health-official-touts-psychedelics-therapeutic-benefits-and-slams-marijuana-scheduling [Last accessed: December 9, 2022].

74.

Caplan

, Moch

. Breakthrough Therapies Act: Good idea, wrong solution. Stat. 2022. Available from: https://www.statnews.com/2022/12/02/breakthrough-therapies-act-good-idea-wrong-solution [Last accessed: December 9, 2022].

75.

Henningfield

, Coe

, Griffiths

, et al. Psychedelic drug abuse potential assessment research for new drug applications and Controlled Substances Act scheduling. Neuropharmacology, 2022; 218:109220.

76.

Barnett

Flawed FDA safety requirements are hamstringing a highly effective treatment for severe schizophrenia. Stat. 2022. Available from: https://www.statnews.com/2022/05/05/flawed-fda-safety-requirements-hamstring-highly-effective-schizophrenia-treatment [Last accessed: December 9, 2022].

77.

Meyers

OI.

The Role of DSM in the EMA and FDA Authorization Process for Psychiatric Drugs. Value Health 2013;16. Available from: https://www.valueinhealthjournal.com/action/showPdf?pii=S1098-3015%2813%2903672-3 [Last accessed: May 16, 2023].

78.

Reset Pharmaceuticals. Reset Pharmaceuticals Enters into Exclusive Worldwide License Agreement with NYU Langone Health for Intellectual Property and Data on Psilocybin and Related Psychedelics for the Treatment of Mental Illness in Patients with Life-Threatening Diseases, Including Cancer. Globe News Wire. 2021. Available from: https://www.globenewswire.com/news-release/2021/07/07/2258793/0/en/Reset-Pharmaceuticals-Enters-into-Exclusive-Worldwide-License-Agreement-with-NYU-Langone-Health-for-Intellectual-Property-and-Data-on-Psilocybin-and-Related-Psychedelics-for-the-Tr.html [Last accessed May 11, 2023].

79.

Marseille

, Bertozzi

, Kahn

. The economics of psychedelic-assisted therapies: A research agenda. Front Psychiatry, 2022; 13; doi: 10.3389/fpsyt.2022.1025726

80.

Small Pharma. Small Pharma Completes Enrollment in Phase IIa DMT-Assisted Psychotherapy. Available from: https://smallpharma.com/press-releases/small-pharma-completes-enrollment-phase-iia-clinical-trial/ [Last accessed: August 1, 2023].

81.

Eleusis. Introducing ELE-Psilo. 2022. Available from: https://www.eleusisltd.com/blog-post/eleusiss-development-of-drug-candidates-introducing-ele-psilo-our-lead-investigational-psilocin-drug-candidate [Last accessed: December 9, 2022].

82.

Vollenweider

, Vollenweider-Scherpenhuyzen

, Bäbler

, et al. Psilocybin induces schizophrenia-like psychosis in humans via a serotonin-2 agonist action. Neuroreport, 1998; 9(17):3897–3902.

83.

Nichols

DE.

Psychedelics. Pharmacol Rev, 2016; 68(2):264–355.

84.

Becker

, Klaiber

, Holze

, et al. Ketanserin reverses the acute response to LSD in a randomized, double-blind, placebo-controlled, crossover study in healthy subjects. Int J Neuropsychopharmacol, 2022:pyac075; doi: 10.1093/ijnp/pyac075 [Epub ahead of print].

85.

Dolgin

Taking the tripping out of psychedelic medicine. Nature, 2022; 609(7929):S80–S82. doi: 10.1038/d41586-022-02869-4

86.

Rosa

, Dorsen

, Penn

. Fostering nurse engagement in psychedelic-assisted therapies for patients with serious illness. J Palliat Med, 2020; 23(10):1288–1289.

87.

Psychedelic Alpha. Psychedelic Bulletin #102—Our Analysis of MindMed's LSD for Anxiety Results; Mail-Order Ketamine May Come Under Scrutiny; Our Notes from PSYCH Symposium. 2022. Available from: https://psychedelicalpha.com/news/psychedelic-bulletin-102-our-analysis-of-mindmeds-lsd-for-anxiety-results-mail-order-ketamine-may-come-under-scrutiny-our-notes-from-psych-symposium [Last accessed: December 9, 2022].

88.

Cavanna

, Muller

, de la Fuente

, et al. Microdosing with psilocybin mushrooms: A double-blind placebo-controlled study. Transl Psychiatry, 2022; 12(1):1–1.

89.

Kaertner

, Steinborn

, Kettner

, et al. Positive expectations predict improved mental-health outcomes linked to psychedelic microdosing. Sci Rep, 2021; 11(1):1–1.

90.

Marschall

, Fejer

, Lempe

, et al. Psilocybin microdosing does not affect emotion-related symptoms and processing: A preregistered field and lab-based study. J Psychopharmacol, 2022; 36(1):97–113; doi: 10.1177/02698811211050556

91.

Szigeti

, Kartner

, Blemings

, et al. Self-blinding citizen science to explore psychedelic microdosing. Elife, 2021; 10:e62878.

92.

COMPASS Pathways & MAPS Public Benefit Corporation. American Medical Association to Issue First New Code for Psychedelic Therapies. Globe Newswire. May 2, 2023. Available from: https://www.globenewswire.com/news-release/2023/05/02/2658960/0/en/American-Medical-Association-to-Issue-First-New-Code-for-Psychedelic-Therapies.html [Last accessed: May 5, 2023].

93.

Barnett

, Ostrovsky

. Psychedelic medicine's future depends on proactive development of a robust medical billing and coding strategy. Psychedelic Med, 2023; 1(1):14–17; doi: 10.1089/psymed.2022.0005

94.

McIntyre

, Carvalho

, Lui

, et al. The effect of intravenous, intranasal, and oral ketamine in mood disorders: A meta-analysis. J Affect Disord, 2020; 276:576–584.

95.

Yaden

, Griffiths

. The subjective effects of psychedelics are necessary for their enduring therapeutic effects. ACS Pharmacol Transl Sci, 2020; 4(2):568–572; doi: 10.1021/acsptsci.0c00194

96.

Devenot

, Conner

, Doyle

. Dark side of the Shroom: Erasing indigenous and counterculture wisdoms with psychedelic capitalism, and the open source alternative: A manifesto for psychonauts. Anthropol Conscious. 2022; 33(2):476–505.

97.

Aday

, Carhart-Harris

, Woolley

. Emerging challenges for ‘psychedelic therapy’. JAMA Psychiatry, 2023; doi: 10.1001/jamapsychiatry.2023.0549

98.

Kargbo

RB.

The psychedelic renaissance: Addressing potential adverse effects in a therapeutic setting. ACS Medi Chem Lett, 2021; 12(12):1874–1875.

99.

Schlag

, Aday

, Salam

, et al. Adverse effects of psychedelics: From anecdotes and misinformation to systematic science. J Psychopharmacol, 2022; 36(3):258–272.

100.

Barsuglia

, Davis

, Palmer

, et al. Intensity of mystical experiences occasioned by 5-MeO-DMT and comparison with a prior psilocybin study. Front Psychol, 2018; 9:2459.

101.

Ortiz Bernal

, Raison

, Lancelotta

, et al. Reactivations after 5-MeO-DMT use in naturalistic settings: An initial exploratory analysis of the phenomenon's predictors and its emotional valence. Front Psychiatry, 2022; 13:2706.

102.

Breeksema

, Kuin

, Kamphuis

, et al. Adverse events in clinical treatments with serotonergic psychedelics and MDMA: A mixed-methods systematic review. J Psychopharmacol, 2022; 36(10), 1100–1117.

103.

Williams

, Labate

. Diversity, equity, and access in psychedelic medicine. J Psychedelic Stud, 2020; 4(1):1–3.

104.

Williams

, Romero

, Braunstein

, et al. Indigenous philosophies and the” Psychedelic Renaissance”. Anthropol Conscious, 2022; 33(2):506–527.

105.

Celidwen

, Redvers

, Githaiga

, et al. Ethical principles of traditional Indigenous medicine to guide western psychedelic research and practice. Lancet Reg Health Am, 2023; 18:100410.

106.

Froese

, Guzmán

, Guzmán-Dávalos

. On the origin of the genus Psilocybe and its potential ritual use in ancient Africa and Europe. Econ Bot, 2016; 70:103–114.

107.

Muraresku

BC.

The Immortality Key: The Secret History of the Religion with No Name. St. Martin's Press: New York, NY; 2020.

108.

Hartogsohn

American Trip: Set, Setting, and the Psychedelic Experience in the Twentieth Century. MIT Press: Cambridge, MA; 2020.

109.

Petrides

, Koulouris

, Lagonikos

. The role of process simulation in pharmaceutical process development and product commercialization. Pharm Eng, 2002; 22(1):56–65.

110.

Sternitzke

Knowledge sources, patent protection, and commercialization of pharmaceutical innovations. Res Policy, 2010; 39(6):810–821.

111.

, Lin

. How do patent-based measures inform product commercialization?—The case of the United States pharmaceutical industry. J Eng Technol Manage, 2018; 50:24–38.

112.

Aday

, Davis

, Mitzkovitz

, et al. Predicting reactions to psychedelic drugs: A systematic review of states and traits related to acute drug effects. ACS Pharmacol Transl Sci, 2021; 4(2):424–435.

113.

Hartogsohn

Set and setting, psychedelics and the placebo response: An extra-pharmacological perspective on psychopharmacology. J Psychopharmacol, 2016; 30(12):1259–1267.

114.

Ceban

, Rosenblat

, Kratiuk

, et al. Prevention and management of common adverse effects of ketamine and esketamine in patients with mood disorders. CNS Drugs, 2021; 35(9):925–934.

115.

Berman

, Cappiello

, Anand

, et al. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry, 2000; 47(4):351–354.

116.

Aday

, Bloesch

, Davoli

. 2019: A year of expansion in psychedelic research, industry, and deregulation. Drug Sci Policy Law, 2020; 6:2050324520974484.

117.

Freedman

, Brown

, Cannon

, et al. Can a framework be established for the safe use of ketamine?. Am J Psychiatry, 2018; 175(7):587–589.

118.

Janssen

Pharmaceuticals

, Inc., [Internet]. Access & Reimbursement Guide: Information to Support the Access & Reimbursement Process for SPRAVATO^®. [cited 2022Dec7]. Available from: https://www.spravatohcp.com/sites/www.spravatohcp.com/files/spravato_access_reimbursement_guideline.pdf?v=4 [Last accessed: May 16, 2023].

119.

Levin

[Internet]. psychiatry.org. APA; 2019 [cited 2022Dec7]. Available from: https://www.psychiatry.org/getattachment/f2ebaa0d-14a9-4493-8939-1039795afb49/APA-Letter-CMS-Esketamine-12312019.pdf [Last accessed: May 16, 2023].

120.

Downey

, Sarris

, Perkins

. Legalization of psychedelic substances. JAMA, 2021; 326(23):2434–2435.

121.

Margolin

How the psychedelic industry can learn from cannabis [Internet]. DoubleBlind Mag. DoubleBlind Mag; 2019 [cited 2022Dec7]. Available from: https://doubleblindmag.com/cannabis-psychedelics-corporatization-compass [Last accessed: May 16, 2023].

122.

Boehnke

, Davis

, McAfee

. Applying lessons from Cannabis to the psychedelic highway: Buckle up and build infrastructure. JAMA Health Forum, 2022; 3(6):e221618.