Intramuscular Delivery of
5-MeO-DMT

For inhalation of the vapors, reproducible and accurate drug delivery is limited by amount inhaled, amount kept in airway dead-space, and time inhaled, factors that are contingent on the patient’s technique and will not be reliable.

  • The intramuscular route that Delos will use obtains predictable and reproducible dose response and plasma levels.

  • This approach always achieves breakthrough psychedelic experience needed for therapeutic benefit.

  • IM has gentler onset than combustion or vaping, yet it is much faster than intranasal.

  • Route is familiar to medical professionals and regulatory agencies.

Inhaled vaping devices have not been approved for medical use in the US, carry a stigma of illicit drug use that will be difficult to convince medical professionals and regulatory agencies to approve.  Patient inhalation effort and technique limits reproducible drug delivery. While safer than classic combustion, vaping is not harmless to pulmonary system.

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5-MeO-DMT

Intramuscular Delivery of
5-MeO-DMT

Intranasal delivery is unreliable, prohibitively slow onset, and unpleasant.

  • Due to poor IN bioavailability, unlikely to reach breakthrough level to the psychedelic experience needed for maximal therapeutic effect.

  • Variations in mucosal edema and mucus in nasal passages, limits drug absorption making it difficult to predict and reproduce absorption and plasma levels.

  • Unpleasant taste, burning effect on nasal passage/sinuses.

  • Very slow onset limits practical use.

Additionally, DELOS Therapeutics has IP for a process that prevents metabolism of 5-MeO-DMT into main metabolite bufotenine which can cause more bodily discomfort.

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Why 5-MeO-DMT for treating depression?

5-MeO-DMT provides a “reset” to the neural pathways in the brain that have formed in the development of chronic depression.  It also is well-known for often producing profound unitive states that are correlated with positive therapeutic outcomes (Davis et al., 2019; Garcia-Romeu et al., 2014; Griffiths et al., 2018). According to Dakic et al. (2017), 5-MeO-DMT serves as an anti-inflammatory agent, inhibits cell death (apoptosis), promotes dendritic arboring (neuroplasticity), which can potentially help build new neural pathways, ways of viewing self and world, and healthier habits. 5-MeO-DMT has also been shown to promote neurogenesis (new neuronal cell creation) in mice (da Cruz, Moulin, Petiz, & Leão, 2018). A single 5-MeO-DMT experience has been shown to maintain lasting therapeutic effects after, even for those who were not intending to receive such effects from it (Uthaug et al. 2019; Davis et al., 2019).

Dakic, V., Minardi Nascimento, J., Costa Sartore, R., Maciel, R. M., de Araujo, D. B., Ribeiro, S., Martins-de-Souza, D., & Rehen, S. K. (2017). Short term changes in the proteome of human cerebral organoids induced by 5-MeO-DMT. Scientific Reports, 7(1), 12863. https://doi.org/10.1038/s41598-017-12779-5

Davis, A. K., So, S., Lancelotta, R., Barsuglia, J. P., & Griffiths, R. R. (2019). 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) used in a naturalistic group setting is associated with unintended improvements in depression and anxiety. The American Journal of Drug and Alcohol Abuse, 45(2), 161-169. https://doi.org/10.1080/00952990.2018.1545024

Garcia-Romeu, A., R Griffiths, R., & W Johnson, M. (2014). Psilocybin-occasioned mystical experiences in the treatment of tobacco addiction. Current Drug Abuse Reviews, 7(3), 157-164. https://10.2174/1874473708666150107121331

Griffiths, R. R., Johnson, M. W., Richards, W. A., Richards, B. D., Jesse, R., MacLean, K. A., … & Klinedinst, M. A. (2018). Psilocybin-occasioned mystical-type experience in combination with meditation and other spiritual practices produces enduring positive changes in psychological functioning and in trait measures of prosocial attitudes and behaviors. Journal of Psychopharmacology, 32(1), 49-69. https://doi.org/10.1177/0269881117731279

Lima da Cruz, R. V., Moulin, T. C., Petiz, L. L., & Leão, R. N. (2018). A Single Dose of 5-MeO-DMT Stimulates Cell Proliferation, Neuronal Survivability, Morphological and Functional Changes in Adult Mice Ventral Dentate Gyrus. Frontiers in molecular neuroscience, 11, 312. https://doi.org/10.3389/fnmol.2018.00312

Uthaug, M. V., Lancelotta, R., van Oorsouw, K., Kuypers, K., Mason, N., Rak, J., Šuláková, A., Jurok, R., Maryška, M., Kuchař, M., Páleníček, T., Riba, J., & Ramaekers, J. G. (2019). A single inhalation of vapor from dried toad secretion containing 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in a naturalistic setting is related to sustained enhancement of satisfaction with life, mindfulness-related capacities, and a decrement of psychopathological symptoms. Psychopharmacology, 236(9), 2653-2666. https://doi.org/10.1007/s00213-019-05236-w

5-MeO-DMT

DELOS Therapeutics

Manifesting Health, Wellness, and Wonder

Microdosing Products

  • Use of digital therapeutics to assist with overcoming depression and obesity alongside microdosing.

  • Use of a formulation that mitigates the development of cardiac valvulopathy.

  • Use of LSD which is long-lasting, has a large neurogenerative profile thus promoting the development of new habits, agonizes 5HT-2C receptors, thus lowering appetite.

  • Take-home medication for study participants and eventually, patients after NDA status is achieved.

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LSD

Why LSD Microdosing for treating depression?

Microdosing in general has been shown to decrease depression (Polito & Stevenson, 2019; Rootman et al., 2021; Cameron et al., 2020; Griffiths et al., 2016; Hutten et al., 2020; Kaertner et al., 2021; Lea et al., 2020), and LSD in particular has longer lasting effects/benefits than many other psychedelics, such as psilocybin.  Additionally, in a Cell Reports study, LSD was found to produce the greatest levels of dendritic arboring and neuroplasticity effects of any other psychedelic compound tested (Ly et al. 2018), thus potentially enabling the development of new, healthier habits and better ways of understanding self and world.  Additionally, microdosing has been found to lower anxiety levels (Anderson et al., 2019; Griffiths et al., 2016; Kaertner et al., 2021; Polito & Stevenson, 2019; Rosenbaum et al., 2020; Szigeti et al., 2021), and anxiety is very often comorbid with depression.

Anderson, T., Petranker, R., Christopher, A., Rosenbaum, D., Weissman, C., Dinh-Williams, L., Hui, K., & Hapke, E. (2019). Psychedelic microdosing benefits and challenges: An empirical codebook. Harm Reduction Journal, 16(1), 43. https://doi.org/10.1186/s12954-019-0308-4

Cameron, L., Nazarian, A., & Olson, D. (2020). Psychedelic Microdosing: Prevalence and Subjective Effects. Journal of Psychoactive Drugs, 52(2), 113–122. https://doi.org/10.1080/02791072.2020.1718250

Griffiths, R., Johnson, M., Carducci, M., Umbricht, A., Richards, W., Richards, B., Cosimano, M., & Klinedinst, M. (2016). Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. Journal of Psychopharmacology, 30(12), 1181–1197. https://doi.org/10.1177/0269881116675513

Hutten, N., Mason, N., Dolder, P., Theunissen, E., Holze, F., Liechti, M., Feilding, A., Ramaekers, J., & Kuypers, K. (2020). Mood and cognition after administration of low LSD doses in healthy volunteers: A placebo controlled dose-effect finding study. European Neuropsychopharmacology, 41, 81–91. https://doi.org/10.1016/j.euroneuro.2020.10.002

Kaertner, L. S., Steinborn, M. B., Kettner, H., Spriggs, M. J., Roseman, L., Buchborn, T., Balaet, M., Timmermann, C., Erritzoe, D., & Carhart-Harris, R. L. (2021). Positive expectations predict improved mental-health outcomes linked to psychedelic microdosing. Scientific Reports, 11(1), 1941. https://doi.org/10.1038/s41598-021-81446-7

Lea, T., Amada, N., & Jungaberle, H. (2020). Psychedelic Microdosing: A Subreddit Analysis. Journal of Psychoactive Drugs, 52(2), 101–112. https://doi.org/10.1080/02791072.2019.1683260

Ly C, Greb AC, Cameron LP, et al. Psychedelics Promote Structural and Functional Neural Plasticity. Cell Rep. 2018; 23(11):3170-3182. http://10.1016/j.celrep.2018.05.022

Polito, V., & Stevenson, R. J. (2019). A systematic study of microdosing psychedelics. PloS One, 14(2), e0211023. https://doi.org/10.1371/journal.pone.0211023

Rootman, J.M., Kryskow, P., Harvey, K. et al. (2021) Adults who microdose psychedelics report health related motivations and lower levels of anxiety and depression compared to non-microdosers. Scientific Reports, 11, 22479 . https://doi.org/10.1038/s41598-021-01811-4

Rosenbaum, D., Weissman, C., Anderson, T., Petranker, R., Dinh-Williams, L., Hui, K., & Hapke, E. (2020). Microdosing psychedelics: Demographics, practices, and psychiatric comorbidities. Journal of Psychopharmacology, 34(6), 612–622. https://doi.org/10.1177/0269881120908004

Szigeti, B., Kartner, L., Blemings, A., Rosas, F., Feilding, A., Nutt, D., Carhart-Harris, R., & Erritzoe, D. (2021). Self-blinding citizen science to explore psychedelic microdosing. ELife, 10, e62878. https://doi.org/10.7554/eLife.62878

Why Microdose LSD for treating obesity?

In addition to LSD agonizing 5HT-2C receptors which produces an appetite suppressant effect, many anecdotal accounts from microdosers indicate an often-increased sense of self-care and wanting to eat healthier and in greater moderation.  

Below are excerpts from an analysis of 29 weight-loss-related posts from  https://reddit.com/r/Microdosing:

“When I dose it’s so much easier to eat like a normal person. It’s like the craving can be negotiated” with for once rather than taking over. I’ve had issues with binge eating in the past. Well every time you correct a habit you are building new pathways so the idea is that is carries over into non-microdosing life.”

“I’ve been suffering from disordered eating ever since I was a child, I’ve been going through various diets and therapy. Nothing has had such an impact on my eating patterns.  Last week I was eating a slice of cake I baked, and after a few bites all I could think was, I’m not really enjoying this anymore, it feels like I’m poisoning my body. I can safely say that I’ve never ever had this kind of thought before….”

“…LSD suppresses my appetite. Sometimes I’ll get home at night on a dose day and realize I didn’t eat anything since breakfast. It doesn’t feel like I’m starving myself, it just feels like I know the difference between eating when I’m hungry and eating when I’m bored.”

“Yes for me: healthier eating (more of portion control) and also less desire to drink alcohol. Those, along with “better” workouts and more motivation to exercise has led to weight loss.”

Delos is preparing an observational study with over 1000 participants to empirically determine the efficacy of LSD microdosing to treat obesity, depression, anxiety, and promote general wellness in life.

LSD

Completed:

Protocol for an observational LSD microdosing study

PROTOCOL: MLSD-O

A Comprehensive Study of the Effects of Microdosing
Lysergic Acid Diethylamide on Wellbeing, Depression and Anxiety, and Obesity

Original Protocol Version 1:
January 17, 2022

An Investigator’s Brochure for 5-MeO-DMT, allowing for clinical trials across various study sites

5-Methoxy-N,N-Dimethyltryptamine Investigator’s Brochure

IB Edition Number: v1.0
IB Edition Date: 11/21/2021

Product Name: 5-Methoxy-N,N-Dimethyltryptamine
Sponsor Name: Delos

Secured a medical clinic in San Francisco to conduct clinical trials on 5-MeO-DMT and microdosing studies

DELOS Therapeutics

DELOS Therapeutics is dedicated to rigorously researching and developing psychedelic medicines with the aim of producing commercially available treatments that are safe, effective, and affordable.

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