WO2025073047A1 - Psychedelic pharmaceutical composition and kit - Google Patents

Abstract

The present invention relates to a pharmaceutical composition that combines psychedelic compounds, such as psilocybin, with one or more other component, such as fungi or plant or animal extracts and isolates, adaptogens, phytochemicals, algae, vitamins, minerals, amino acids, psychobiotics, or other such materials to improve user experience as compared to conventional psychedelics. A kit to modulate the effects of psychedelic compounds is also described. The present formulation is believed to have application in psychedelic-assisted therapy.

Description

PSYCHEDELIC PHARMACEUTICAL COMPOSITION AND KIT

CROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims the benefit under 35 U.S.C. 119(e) of provisional patent application S.N. 63/542,110 filed October 3, 2023, the contents of which are hereby incorporated by reference

BACKGROUND OF THE INVENTION

FIELD OF THE INVENTION

[0002] In one of its aspects, the present invention relates to pharmaceutical compositions, and more particularly to pharmaceutical compositions comprising psychedelic compounds.

DESCRIPTION OF THE PRIOR ART

[0003] Mental health disorders are a growing public health concern, with some estimates calculating that between 1 in 2 and 1 in 5 individuals will suffer from some form of mental illness in their lifetime. Pharmacotherapies are often the first recommended line of treatment; however, there is a growing concern around their safety and efficacy. Reports suggest that such pharmacological interventions are often no more statistically effective than placebo, can be highly addictive, frequently have serious side effects, can be expensive, and can require a lifelong commitment. Similarly, therapy and counselling can be difficult to access, with long wait times and high costs. There is a need for safe and effective pharmacotherapies.

[0004] Psychedelic compounds have been used medicinally for centuries. Psilocybin is one example of such a compound. Psilocybin-containing mushrooms, often collectively referred to as "magic mushrooms", are a group of fungi known for their psychoactive properties. There are over 180 known species of mushrooms that contain psychoactive properties, belonging to various genera, with the most well-known being Psilocybe. Psilocybin, and its metabolite psilocin, is the major psychoactive agent in these mushrooms, the effects of which include altered states of consciousness, visual hallucinations, and changes in perception and cognition.

[0005] Psychedelic-assisted therapy is being studied in a wide range of conditions and has been demonstrated to be a safe and effective treatment with relatively few side effects. For example, evidence suggests that psilocybin has therapeutic utility in cancer-related depression and anxiety, treatment-resistant depression, alcohol use disorder, and tobacco addiction, amongst others. Psilocybin has also been investigated for use in treating obsessive compulsive disorder, migraines, cluster headaches, anorexia, bipolar disorder, and chronic pain.

[0006] Despite growing evidence of the therapeutic potential of psychedelic compounds and their favourable safety profiles, there remain barriers to the acceptance and use of these compounds.

[0007] One such barrier is the psychological and physical distress that some users may experience with psychedelic compounds, which have been reported to include anxiety, nausea, gastro-intestinal distress, muscle tension, increased heart rate, acute Restless Leg Syndrome, and tremors/shaking. Users may also experience acute anxiety, fear, confusion, and other negative emotions, including so-called “ego dissolution”, an aspect that can be experienced with larger doses of psychedelic compounds. In rare cases, users may experience a condition known as Hallucinogen-persisting perception disorder (HPPD), which can be quite serious, dangerous, and/or debilitating. Another barrier is that some users may experience instances of muscle weakness or paralysis during or after use of psychedelic compounds, with cases ranging from mildly uncomfortable to debilitating, lasting minutes, hours, or days. While largely reported to be acute and related to the therapeutic nature of the emotional processing that can occur during the use of psychedelic compounds, the risk of psychological and/or physical distress may deter some potential users. Similarly, many firsttime users may not return to psychedelic-assisted therapy after experiencing such adverse effects. Furthermore, it has been found that psychological state, emotions, and expectations can influence the psychedelic experience itself, so apprehension relating to possible side effects may detract from the positive effects of psychedelic compounds and in some cases, trigger an overall negative experience.

[0008] Apprehension to engage in psychedelic-assisted therapy may also relate to the experience of ingesting the psychedelic compounds, which may include aversion to the taste, smell, or appearance of the product. Again, such aversion may dissuade potential users and, for those that do engage in psychedelic-assisted therapy, may detract from the positive effects of psychedelic compounds.

[0009] Another barrier to the acceptance and use of psychedelic-assisted therapy is the lack of efficiency when psychedelic compounds are ingested. For example, it has been reported that botanical psilocybin is only 50% bioavailable when ingested, thereby often requiring a large volume of biomass to be ingested to achieve the desired dose of psilocybin. This has been addressed through extraction and purification processes. Synthetic versions of psychedelic compounds, such as synthetic psilocybin, have also been produced. However, in addition to increasing the cost of production, these methods tend to remove other potentially beneficial bio-alkaloids found in the psychedelic compound-containing plants or animals, such as those found in psilocybin-containing mushrooms.

[0010] For example, there are several bio-alkaloids, in addition to psilocybin, that are found in psilocybin-containing cultivars. These include norpsilocin, baeocystin, norbaeocystin, aeruginascin, and B-carbolines. Benefits from several of these compounds working together (the so-called “entourage effect”) have been reported. For example, there is preliminary evidence that some of these compounds are responsible for the euphoric effect and elimination of anxiety commonly attributed to the psilocybin experience. One example is B- carbolines, which have been found to be metabolized by gut monamine oxidase, potentiating greater bioavailability, longevity, and intensity of the effects of botanical psilocybin, thereby improving the overall potency and resulting experience. Such “entourage effects” would not be present in purified or synthetic psilocybin.

[0011] Other examples of psychedelic compounds include muscimol, muscarine, and ibotenic acid, which can be found in Amanita muscaria mushrooms; ibogaine, which can be found in the root bark of the Tabernanthe iboga: 5-MeO-DMT, which can be found in Dictyonema huorani’ lysergic acid and ergotamine, which can be found in ergot; mescaline, which can be found in certain cacti (such as the Mexican Peyote cactus (Lophohora williamsii) and the San Pedro cactus); collybolide which can be found in Rhodocollybia maculata mushroom; salvinorin A. which can be found in Salvia divinorunr, myristicin, elemicin, eugenol, and safrole, which can be found in nutmeg; hyoscyamine, atropine, atropamine, belaplomine, and scopolamine, which can be found in Atropa belladonna’ bufotenine, dermorphin, and other such psychedelic compounds found in certain toads and frogs, such as the Colorado River toad; and psychedelic compounds found in certain fish, including sea chubs (from the genus Kyphosus), Siganus spinus, Mulloidichthys flavolineatus, and Sarpa salpa.

[0012] Despite the advances made to date in the development of psychedelic formulations, there is room for improvement to address the above-mentioned problems and shortcomings of the prior art.

SUMMARY OF THE INVENTION

[0013] It is an object of the present invention to obviate or mitigate at least one of the above- mentioned disadvantages of the prior art. [0014] It is another object of the present invention to provide a novel psychedelic composition.

[0015] Accordingly in one of its aspects, the present invention provides a pharmaceutical composition comprising one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and one or more of the following: one or more alkaloid; material from one or more non-psilocybin-containing mushroom; one or more cannabinoid; one or more terpene; one or more flavonoid; one or more flavouring agent; one or more aromatic agent; one or more colouring agent; one or more antiemetic agent; one or more agent to reduce gastro-intestinal distress; one or more agent to reduce anxiety; one or more agent to reduce Restless Leg Syndrome; one or more agent to alleviate tachycardia; one or more potentiating agent; one or more glutamate modulating agent; one or more agent to reduce muscle weakness; and one or more agent to reduce shaking or tremors.

[0016] In another of its aspects, the present invention provides a pharmaceutical kit comprising pharmaceutical composition comprising one or more psychedelic compound, such as psilocybin, and one or more agents that can mediate the effects of psychedelic compounds.

[0017] Thus, the present inventor has developed a pharmaceutical composition comprising one or more psychedelic compounds. The present formulation has improved appearance, aroma, and taste as compared to conventional psychedelic products, and reduces common psychological and physical side effects associated with psychedelic compounds. The formulation also increases the bioavailability of psychedelic compounds and potentiates their effects, reducing the volume of biomass required for each dose. The present formulation is believed to improve user experience as compared to conventional psychedelic products and therefore have application in psychedelic-assisted therapy. The present inventors have also developed a pharmaceutical kit, comprising the psychedelic-containing pharmaceutical composition and one or more agents that can mediate the effects of psychedelic compounds.

[0018] To the knowledge of the inventors, a psychedelic composition and kit having such a combination of features are heretofore unknown.

[0019] Other advantages of the invention will become apparent to those of skill in the art upon reviewing the present specification.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] The present invention relates to a pharmaceutical composition comprising one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and one or more of the following: one or more alkaloid; material from one or more non- psilocybin-containing mushroom; one or more cannabinoid; one or more terpene; one or more flavonoid; one or more flavouring agent; one or more aromatic agent; one or more colouring agent; one or more antiemetic agent; one or more agent to reduce gastro-intestinal distress; one or more agent to reduce anxiety; one or more agent to reduce Restless Leg Syndrome; one or more agent to alleviate tachycardia; one or more potentiating agent; one or more glutamate modulating agent; one or more agent to reduce muscle weakness; and one or more agent to reduce shaking or tremors.

[0021] The present invention also relates to a pharmaceutical kit comprising pharmaceutical composition comprising one or more psychedelic compound, such as psilocybin, and one or more agents that can mediate the effects of psychedelic compounds.

[0022] Preferred embodiments of the present invention will be described with reference to the following exemplary information which should not be used to limit or construe the invention.

[0023] This disclosure encompasses a pharmaceutical composition comprising one or more psychedelic compound. In some embodiments, the psychedelic compound may be psilocybin derived from material from at least one psilocybin-containing mushroom. Such material may be derived from one of or a combination of psilocybin-containing mushrooms, including but not limited to Bellcaps (Pholiotina), Cone Caps (Conocybe), Deadly Galerinas (Galerina), Laughing Gyms (Gymnopilus), fibrecaps (Inocybe), Copelandia (Panaeolu), Mottlegills (Panaeolu), Magic mushrooms (Pluteus), Liberty Caps Pluteus), and Shield mushrooms (Pluteus). In other embodiments, the psychedelic compounds may include one of more of muscimol, muscarine and ibotenic acid, such as that derived from Amanita muscaria mushrooms; ibogaine, such as that derived from Tabernanthe iboga: 5-MeO-DMT, such as that derived from Dictyonema huoranr, lysergic acid and ergotamine, such as that derived from ergot; mescaline, which can be found in certain cacti (such as the Mexican Peyote cactus (Lophohora williams!!) and the San Pedro cactus); collybolide such as that derived from Rhodocollybia maculata mushroom; salvinorin A. such as that derived from Salvia divinorunr, myristicin, elemicin, eugenol, and safrole, such as that derived from nutmeg; hyoscyamine, atropine, atropamine, belaplomine, and scopolamine, such as that derived from Atropa belladonna’ bufotenine, dermorphin, and other such psychedelic compounds derived from certain toads and frogs (such as the Colorado River toad); and psychedelic compounds found in certain fish, including sea chubs (from the genus Kyphosus), Siganus spinus, Mulloidichthys flavolineatus, and Sarpa salpa. The material may comprise one of or a combination of biomass, which may be powered, grounded, or otherwise processed, oil, crystal, or other matter. [0024] In some embodiments, the pharmaceutical composition may comprise material from at least one psilocybin-containing lichen. In other embodiments, the pharmaceutical composition may comprise synthetic psychedelic compounds, such as synthetic psilocybin.

[0025] The present pharmaceutical composition comprises any pharmacologically suitable dosage of a psychedelic compound. For example, a suitable dosage of psilocybin may be from about 1 mg to about 1500 mg, and preferably from about 1 mg to about 50 mg. As other examples, a suitable dosage of mescaline may be 300-500 mg, of LSD may be 20-80 pg, and amanita muscaria may be 10-500 mg.

[0026] In some embodiments, the pharmaceutical composition may further comprise alkaloids that have been extracted, separated, and/or purified from plants, fungi, and animals. While not wishing to be bound by any particular theory or mode of action, alkaloids may produce an entourage effect with the one or more psychedelic compounds, which may include euphoria, elimination of anxiety, increased bioavailability of the one or more psychedelic compounds, and increased overall potency of the one or more psychedelic compounds and/or effects of same. Alkaloids may include but are not limited to baeocystin, aeruginacyn, norbaeocystin, norpsilocin, and beta-carbolines. In some embodiments, the alkaloids, such as those listed above, may be extracted, separated, and/or purified from psilocybin-containing mushrooms. In other embodiments, the alkaloids may be extracted from plant or animals sources or may be synthetic.

[0027] In some embodiments, the pharmaceutical composition may further comprise material from one or more non-psilocybin-containing mushroom, such as Lion’s Mane (Hericium erinaceus), Reishi (Ganoderma lucidurri), Caterpillar fungus (Cordyceps), and Chaga mushroom (Inonotus obliquus). The material may comprise one of or a combination of biomass, which may be powered, grounded, or otherwise processed, oil, crystal, or other matter.

[0028] The pharmaceutical composition may further comprise one or more cannabinoids, which may include but is not limited to cannabichromene (CBC) cannabidiolic acid (CBDA), cannabidiol (CBD), cannabinol (CBN), cannabifuran (CBF), cannabigerol (CBG), cannabidivarin (CBDV), cannabicyclol (CBL), cannabitriol (CBT), tetrahydrocannabinolic acid (THCA), tetrahydrocannabivarin (THCV), and tetrahydrocannabinol (THC).

[0029] The pharmaceutical composition may further comprise one or more terpene, which may include but is not limited to myrcene, limonene, pinene, caryophyllene, humulene, terpinolene, ocimene, bisabolol, geraniol, phytol, valencene, pulegone, eucalyptol, and camphene. Terpenes may be extracted from a natural source or may be synthetic. The one or more terpene may be in the form of a powder, extract, oil, crystal, or other suitable form.

[0030] The pharmaceutical composition may further comprise one or more flavonoid, which may include but is not limited to cannaflavins (including cannflavin A, cannflavin B, and cannflavin C), quercetin, apigenin, kaempferol, luteolin, orientin, quercetagetin, and vitexin. Flavonoids may be extracted from a natural source or may be synthetic. The one or more flavonoid may be in the form of a powder, extract, oil, crystal, or other suitable form.

[0031] In some embodiments, the pharmaceutical composition may further comprise a flavouring agent. While not wishing to be bound by any particular theory or mode of action, the flavouring agent may reduce a user’s aversions to the formulation and may assist in creating a positive experience for the user. Suitable flavouring agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can produce a desired flavour, including but not limited to essential oils and chemical constituents of essential oils that can impart a desired flavor. Examples include linalool, lemon balm, lemon extract, peppermint extract, bee balm, and wild bergamot herb.

[0032] In some embodiments, the pharmaceutical composition may further comprise an aromatic agent. While not wishing to be bound by any particular theory or mode of action, the aromatic agent may reduce a user’s aversions to the formulation and may assist in creating a positive experience for the user. Suitable flavouring agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can produce a desired aroma, including but not limited to essential oils and chemical constituents of essential oils that can impart a desired aroma. Examples include linalool, lemon balm, lemon extract, peppermint extract, bee balm, and wild bergamot herb.

[0033] In some embodiments, the pharmaceutical composition may further comprise a colouring agent. While not wishing to be bound by any particular theory or mode of action, the colouring agent may reduce a user’s aversions to the formulation and may assist in creating a positive experience for the user. Suitable colouring agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can produce a desired colour.

[0034] The pharmaceutical composition may further comprise one or more antiemetics. Suitable antiemetics contemplated for use herein include any known pharmaceutically- acceptable substance or combination thereof that can reduce nausea, including but not limited to botanicals and vitamins. Examples of botanicals include Akintunde Vati (Ayurvedic formulation), Alma (Emblica officinalis), Bao He Wan/Balanex Extract (TCM formulation), Bahera (Terminalia bellirica), Black Cohosh (Actaea racemosa), Broom Snakeweed (Gutierrezia sarothrae), Cardamom (seed) (Elettaria cardamomum), Chamomile (Matricaria chamomilla), Chokecherry (Prunus virginiana), Cinnamon (Cinnamomum verum), Cloves (Syzygium aromaticum), Cumin (Cuminum cyminum), Dhania (Coriandrum sativum), Fennel (Foeniculum vulgare), Feverwort (Tanacetum parthenium), Galangal (Alpinia galanga), Ginseng (Panax ginseng), Ginger (Zingiber officinale), Giloy Satva (Tinospora cordifolia), Guduchi (Tinospora cordifolia), Haritaki (Terminalia chebula), Horehound (Marrubium vulgare), Honey (Apis mellifera), Jeerak (Cuminum cyminum), Lemon (Citrus limon), Lime (Citrus aurantiifolia), Licorice (Glycyrrhiza glabra), Mint (Mentha spp.), Nutmeg (Myristica fragrans), Peppermint (Mentha piperita), Pippali (Piper longum), Raspberry (Rubus idaeus), Rooibos (Aspalathus linearis), Sounf (Foeniculum vulgare), Spearmint (Mentha spicata), Star Anise (lllicium verum), tuckahoe (Poria cocos), and Triphala (Terminalia chebula, Terminalia bellirica, Phyllanthus emblica). Example of vitamins include Vitamin B6 (Pyridoxine), Vitamin B9 (Folic acid or folacin), Vitamin B12 (Cobalamin), and Calcium (pearl, coral, agate, calx). The one or more antiemetic may be in the form of a powder, extract, oil, crystal, or other suitable form. In some embodiments, the antiemetic may be synthetic.

[0035] The pharmaceutical composition may further comprise one or more agent to reduce gastro-intestinal distress. Suitable agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can reduce gastrointestinal distress. In some embodiments, the agent may be derived from a botanical source, such as Aloe Vera (Aloe barbadensis miller), Apple Cider Vinegar (Acetic acid bacteria), Basil (Ocimum basilicum), Caraway (Carum carvi), Chamomile (Matricaria chamomilla), Cinnamon (Cinnamomum verum), Citrus Peel (Citrus spp.), Cloves (Syzygium aromaticum), Dandelion (Taraxacum officinale), Devil’s Claw (Harpagophytum procumbens), Fennel (Foeniculum vulgare), Figs (Ficus carica), Garlic (Allium sativum), Ginger (Zingiber officinale), Hawthorn Berry (Crataegus spp.), Hing (Ayurvedic remedy) (Asafoetida), Honey (Apis mellifera), Licorice (Glycyrrhiza glabra), Mint (Mentha spp.), Onion (Allium cepa), Pippali (Piper longum), Rosemary (Rosmarinus officinalis), Sage (Salvia officinalis), Saw Palmetto (Serenoa repens), Slippery Elm (Ulmus rubra), Sumac (Rhus spp.), Wild Ginger (Asarum spp.), Xiao Yao San (Radix bupleuri, Radix Paeoniae Alba, Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae, Poria, Radix Glycyrrhizae, Herba Menthae), and Yarrow (Achillea millefolium). In other embodiments, the agent may be derived from a non-botanical source, such as Bifidobacterium Breve, Bifidobacterium Infantis, Lactase (lactase-phlorizin hydrolase), Lactobacillus Acidophilus, Lactobacillus Plantarum, Magnesium (magnesium citrate), Maltosyl-isomaltooligosaccharide, Saccharomyces Boulardii, and Sodium Bicarbonate. In some embodiments, the agent may be synthetic. The agent may be in the form of a powder, extract, oil, crystal, or other suitable form.

[0036] The pharmaceutical composition may further comprise one or more agent to reduce muscle tension. Suitable agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can reduce muscle tension. In some embodiments, the agent may be derived from a botanical source, such as Alfalfa (Medicago sativa), Allspice (Pimenta dioica), Aspen (inner bark), (Populus spp.), CBD (Cannabidiol), Devil’s Claw (Harpagophytum procumbens), Evening Primrose (Oenothera biennis), Feverfew (Tanacetum parthenium), Grapefruit (seeds, pulp), (Citrus paradisi), Greenbriar (Smilax spp.), Hops (Humulus lupulus), Mullein (Verbascum thapsus), Osha (Ligusticum porteri), Passion Flower (Passiflora incarnata), Pennyroyal (Mentha pulegium), Pleurisy Root (Asclepias tuberosa), Rose Hip (Rosa spp.), Rosemary (Rosmarinus officinalis), Sage (Salvia officinalis), Saint John’s Wort (Hypericum perforatum), Skullcap (Scutellaria spp.), Spearmint (Mentha spicata), Sweetflag (Acorus calamus), Tribulus (T ribulus terrestris), Valerian (Valeriana officinalis), White Pine (Pinus strobus), White Willow (Salix alba), Wild Black Cherry (Prunus serotina), Wild Yam (Dioscorea villosa), and Willow (Salix spp.). In other embodiments, the agent may be derived from a non-botanical source, such as Bifidobacterium Breve, L-Glutamine (2,5-Diamino-5-oxopentanoic acid), Omega-6 (gamma-linolenic acid), Streptococcus Thermophilus, and Testosterone (Androst-4-en-17|3-ol-3-one), or may be a vitamin or mineral, such as Vitamin B6 (Pyridoxine), Vitamin B9 (Folic acid or folacin), Vitamin B12 (Cobalamin), Vitamin D (calciferol), and Magnesium (magnesium citrate). In some embodiments, the agent may be synthetic. The agent may be in the form of a powder, extract, oil, crystal, or other suitable form.

[0037] The pharmaceutical composition may further comprise one or more agent to reduce anxiety. Suitable anxiolytic agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can reduce anxiety. In some embodiments, the anxiolytic agent may be derived from a botanical source, African Potato (Hypoxis hemerocallidea), African Wormwood (Artemisia afra), Amla (Indian gooseberry), Ashwagandha (Withania somnifera), Bee Balm or Monarda (Wild Bergamot Herb), Blue Skullcap (Scutellaria lateriflora), Bracted Vervain (Verbena bracteate), Blue Vervain (Verbena hastata), European Vervain (Verbena officinalis), Bupleurum, Cyperus (Chaihu shugansan), California Mugwort (Artemisia douglasiana), California Poppy (Eschscholzia californica), California Tree Poppy or Tree Poppy (Dendromecon rigida), Calming and Purging Powder (Kaixinsan), Camphor Tree (Cinnamomum camphora), Cape Tephrosia (Tephrosia capensis), Cape-Myrtle (Maerua angolensis), Cardamom (Elettaria cardamomum), Chaihu (Bupleurum), Chamomile (Matricaria chamomilla), Chinese Thornapple or Fierce Thornapple (Datura ferox L), Chinese Thorowax (Bupleurum chinense), Chinese Skullcap (Scutellaria baicalensis), Churna, Citronella Grass (Cymbopogon nardus), Corn Chamomile (Anthemis arvensis L), Curcumin (Curcuma longa), Echinacea (Echinacea purpurea), Eleutherococcus (Eleutherococcus senticosus), False Daisy (Bhringaraj), False Pepper Tree (Schinus molle L), Fennel (Foeniculum vulgare), Garden Angelica (Angelica archangelica), Gardenia Fruit (Gardeniae fructus), Giant Alepidea (Alepidea amatymbica), Ginkgo or Maidenhair Tree (Ginkgo Biloba), Golden Shower (Galphimia Glauca), Gotu Kola (Centella asiatica), Hawthorn (Crataegus monogyna Jacq.), Hops (Humulus lupulus L), Houpu Magnolia (Magnolia officinalis), Indian Pennywort (Centella asiatica), Jimsonweed or Common Thornapple (Datura stramonium L), (fresh leaves), Jujube date (Ziziphus jujuba), Kanna (Sceletium tortuosum), Kava (Piper methysticum), Lavender (Lavandula spp.), Lemon Balm (Melissa officinalis), Lemon Verbena (Aloysia citrodora), Lesser Calamint (Clinopodium nepeta), Licorice or Glycyrrhiza (Ganmaidazao), Liquorice Root (Glycyrrhiza), Maidenhair Fern (Adiantum capillus-veneris), Marshmallow (Althaea officinalis), Mexican Skullcap (Scutellaria Mexicana), Mexican Tarragon (Tagetes lucida), Milk Thistle (Silybum marianum), Milkweed (Asclepias), Morus (Morus spp.), Motherwort (Leonurus cardiaca), Motherwort Root (Leonurus japonicus), Nettle (Urtica dioica), Nutmeg (Myristica fragrans), Oregano (Origanum vulgare), Passionflower (Passiflora incarnata), Paw Paw (Asimina triloba), Peppermint (Mentha piperita), Periwinkle (Catharanthus roseus), Pineilia and Magnolia Decoction (Banxia houpo), Pinkroot (Spigelia marilandica), Prickly Ash (Zanthoxylum americanum), Passion Vine (Passiflora incarnata), Radix Ophiopogonis (Ophiopogon root), Ribwort Plantain (Plantago lanceolata), Rhodiola (Rhodiola rosea), Rock Rose (Cistus incanus), Rosemary (Rosmarinus officinalis), Rue (Ruta graveolens), Saussurea (Saussurea spp.), Saw Palmetto (Serenoa repens), Scullcap (Scutellaria), Self Heal (Prunella vulgaris), Senega (Polygala senega), Sensitive Plant (Mimosa pudica), Serratula (Serratula spp.), Shen Jin Cao (Lycopodium serratum), Skullcap (Scutellaria), Spikenard (Jatamansi), Spilanthes (Spilanthes spp.), St. John's Wort (Naughty Man's Plaything), (Hypericum perforatum), Stone Root (Collinsonia canadensis), Sweet Annie (Artemisia annua), Sweet Marjoram (Origanum majorana), Thyme (Thymus vulgaris), Tinnevelly Senna (Cassia angustifolia), Jia Wei Zhenzhu An Chuang Wan, Kamishoyosan, Turmeric (Curcuma longa), Uva Ursi (Artemisia uva-ursi, bearberry, kinnikinnick), Valence or Valerian (Valeriana officinalis), Valerian Root (Valeriana jatamansi), Vervain (Verbena officinalis), Violet (Viola spp.), Vervain (Verbena officinalis), Water Hyssop (Brahmi), Western Skunk Cabbage (Lysichiton americanum), White Willow (Salix alba), Wild Lettuce (Lactuca virosa), Wild Yam (Dioscorea villosa), Wood Betony (Stachys officinalis), Wood Sage (Teucrium scorodonia), Woodruff (Galium odoratum), Wormseed (Artemisia cina), Wormwood (Artemisia absinthium), Yarrow (Achillea millefolium), Yerba Santa (Eriodictyon californicum), Yohimbe (Pausinystalia yohimbe), and Zedoary (Curcuma zedoaria). In other embodiments, the anxiolytic agent may be derived from a non-botanical source, such as Bifidobacterium Longum, GABA (gamma-aminobutyric acid), Lactobacillus Rhamnosus, L- Theanine (L-y-glutamylethylamide), Melatonin (N-acetyl-5-methoxytryptamine), Omega-3 (eicosapentaenoic acid, docosahexaenoic acid), and 5-HTP (5-hydroxytryptophan). In some embodiments, the anxiolytic agent may be a vitamin, such as, Vitamin B (pyridoxine, folate, cobalamin), Vitamin B3 (nicotinic acid), Vitamin B6 (Pyridoxine), Vitamin B9 (Folic acid or folacin), Vitamin B12 (Cobalamin), Vitamin C (Ascorbic acid), and Vitamin D (calciferol), or mineral, such as Magnesium (magnesium citrate) and Zinc (zinc sulfate), or an amino acid, such as Glycine, GABA, L-Theanine, and Omega 3 Fatty Acids. In other embodiments, the anxiolytic agent may be a psychobiotic, such as Lactobacillus rhamnosus, Bifidobacterium longum, Lactobacillus plantarum, Lactobacillus helveticus, Lactobacillus reuteri, Lactobacillus casei, Lactobacillus fermentum, Bifidobacterium breve, and Galacto-oligosaccharide. In some embodiments, the anxiolytic agent may be synthetic. The anxiolytic agent may be in the form of a powder, extract, oil, crystal, or other suitable form.

[0038] The pharmaceutical composition may further comprise one or more agents to reduce Restless Leg Syndrome. Suitable agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can reduce the symptoms of Restless Leg Syndrome. In some embodiments, the agent may be derived from a botanical source, such as Valarian Root (Valeriana officinalis), Passionflower (Passiflora incarnata), CBD (cannabidiol), Chamomile (Matricaria chamomilla), and Ginkgo biloba, or may be a mineral, such as magnesium. In some embodiments, the agent may be synthetic. The agent may be in the form of a powder, extract, oil, crystal, or other suitable form.

[0039] The pharmaceutical composition may further comprise one or more agents to alleviate tachycardia. Suitable agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can reduce an increased heart rate. In some embodiments, the agent may be derived from a botanical source, such as Hawthorn (Crataegus monogyna Jacq.), Motherwort (Leonurus cardiaca), Linden (Tiliae flos), Lemon balm (Melissa officinalis), Passion Flower (Passiflora incarnata), Valerian (Valeriana officinalis), Lavender (Lavandula spp.), Chamomile (Matricaria chamomilla), Ginkgo biloba, and Cayenne (Capsicum annuum). In some embodiments, the agent may be synthetic. The agent may be in the form of a powder, extract, oil, crystal, or other suitable form. [0040] The pharmaceutical composition may further comprise one or more agents to alleviate negative experiences associated with “ego dissolution” (such as fear, panic, terror, confusion). Suitable agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can reduce, inhibit, or prevent the production, release or uptake or otherwise mitigate the impact of glutamate, including but not limited to glutamate uptake in the medial pre-frontal cortex and hippocampus. In some embodiments the agent may be derived from a botanical source, such as ginger/Zingiber officinale Roscoe (gingerols, shogaols, paradols), Volkameria inermis (flavone Acacetin), Huperzia serrata (Huperzine A), Uncaria rhynchophylla (Rhynchophylline), panax notoginseng (ginsenosides, Dencichine), Sophora flavescens Ait (Oxymatrine), Salvia miltiorrhiza Bunge (Magnesium lithospermate B), Polygala tenuifolia (senegenin), Glycyrrhiza glabra/licorice (Isoliquiritigenin), Gastrodia elata Blume (Gastrodin), A. tatarinowii Schott (P-asarone), Angelica gigas/Saururus chinensis/Schisandra chinensis (ESP-102), Radix puerariae (Puerarin), Bupleurum yinchowense (Total saikosaponins), Shiitake (Lentinan), Cordyceps militaris (3’- Deoxyadenosine/3’-dA, Cordycepin), Cortex Mori Radicis (benzofuran-type stilbene glycosides), Radix Paeoniae alba (paeoniflorin), Salvia miltiorrhiza Bunge (tanshinone), Herba Cistanche (Echinacoside), Clerodendrum inerme (L.) Gaertn (Acacetin), Alpinia officinarum Hance (Galangin), Smilacis chinae rhizome (Oxyresveratrol, catechin, epicatechin), Schisandra chinensis (Turcz.) Baill (schisantherin B), Acorus tatarinowii (Schott) (Alphaasarone), barberry/goldenseal/tree turmeric (berberine), Monochasma savatieri Franch. ex Maxim (isoacteoside), Epimedium brevicornum (icariin). Other agents may be derived from vitamins and minerals such as vitamin C, magnesium, vitamin D, omega-3 fatty acids, taurine, zinc, CoQ10. Such agents may be in the form of a powder, extract, oil, crystal, or other suitable form. Other agents may include memantine or riluzole.

[0041] The pharmaceutical composition may further comprise one or more agents to alleviate muscle weakness, including so-called “Wood Lovers Paralysis”. Suitable agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can reduce muscle weakness, including but not limited to iron, B12, magnesium, CoQ10, Vitamin D, Creatine, Ginseng, Folic Acid, Caffene. Electrolytes, Potassium, antihistamines, mestinon, pyridostigmine, prednisone, Compound Huangqi, Bupi Qiangli, Astragali Radix, Codonopsis Radix, Atractylodis Macrocephalae Rhizoma, Angelicae Sinensis Radix, Epimedii Folium, Aconiti Lateralis Radix Praeparata, Smilacis Glabrae Rhizoma, Qilian, Yiqi Jianpi, Bupi Yishen, Yiqi Qushi, and Buzhong Yiqi. The agent may be in the form of a powder, extract, oil, crystal, or other suitable form. [0042] The pharmaceutical composition may further comprise one or more agents to alleviate shaking and tremors. Suitable agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can reduce psychedelic- induced shaking and tremors, including but not limited to- 5-HTP, B1 , B6, B12, Buzhong Yiqi passionflower, and magnesium. The agent may be in the form of a powder, extract, oil, crystal, or other suitable form.

[0043] In some embodiments, the pharmaceutical composition may further comprise a potentiating agent. While not wishing to be bound by any particular theory or mode of action, a potentiating agent may inhibit the enzymes responsible for breaking down psychedelic compounds and their metabolites in the user’s body. This may lead to higher concentrations of psychedelic compounds in the user’s bloodstream and may result in more intense and prolonged psychedelic experiences, or may achieve similar effects from lower doses of one or more psychedelic compounds. These potentiating agents may also increase bio-availability of other active ingredients in the formulation. Suitable agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can potentiate the effects of psychedelic compounds. In some embodiments, the potentiating agent may be derived from a botanical source, such as African Potato or Yellow Star Grass (Hypoxis hemerocallidea), Areca nut or Betel nut (Arecanut), b-caapi (Banisteriopsis caapi), Balloon Plant or Swan Plant (Gomphocarpus physocarpus), Bushman's Grape or Wild Grape (Rhoicissus tridentata), Caltrop (Tribulusterrestris), Camphor Tree (Cinnamomum camphora), Carthamus tinctorius (Naodesheng formula), Chinese Skullcap (Scutellaria baicalensis), Common Plantain or Broadleaf Plantain (Plantago major), Cowhage (Mucuna pruriens), Curcumin (Curcuma longa), Croucher's Gasteria (Gasteria croucheri), Dog Rose or Wild Rose (Rosa canina), Evodia Fruit or Wuzhuyu (Evodiae Fructus), Fragrant ginger/galangal (Kaempferia galangal), Ginkgo or Maidenhair Tree (Ginkgo biloba), Goldthread (Coptis chinensis), Goldenseal (Hydrastis canadensis), Green tea (Camellia sinensis), Heart-leaved moonseed (Tinospora cordifolia), Hairy Betony or Fuzzy Woundwort (Stachys pilifera), Horsewood or Perfume Tree (Clausena anisata), Indian Chrysanthemum (Chrysanthemum indicum), Jimsonweed or Thorn Apple (Datura stramonium), Korean Evodia or Bee Bee Tree (Tetradium daniellii), Licorice (Glycyrrhiza glabra), Lobed Kudzuvine (Naodesheng formula), Lion’s Main (Hericium erinaceus), Nutmeg (Myristica fragrans), Oregon Grape (Mahonia aquifolium), Ox Tongue (Gardenia jasminoides), Passion Flower (Passiflora incarnata), Paintbrush Lily or Blood Lily (Scadoxus puniceus), Pineilia Rhizome or Pineilia (Pinelliae Tuber), Puncturevine or Tribulus (T ribulus terrestris), Radix Notoginseng (Naodesheng formula), Rhizoma Chuanxiong, Lobed Kudzuvine, Carthamus tinctorius, Radix Notoginseng, Crataegus pinnatifida, Sage-leaved Butterfly Bush (Buddleja salvifolia), Schisandra Berry or Five-Flavor Berry (Schisandrae Fructus), Silver Mound (Artemisia Messer-Schmidtiana), Shatavari or Wild Asparagus (Asparagus racemosus), Syrian rue seed (Peganum harmala), Tobacco (Nicotiana tabacum), Turkish Hog's Fennel or Bekta§i Fennel (Ferulago angulata), Water Mint (Mentha aquatica), Water spinach (Ipomoea aquatica), Weeping Boer Bean or Huilboerboon (Schotia brachypetala), Wild Dagga or Lion's Tail (Leonotis leonurus), Wild Yam or Drege's Yam (Dioscorea dregeana), Wild Asparagus or Wave-leaf Xysmalobium (Xysmalobium undulatum), and Yellow mombin (Spondias mombin), Berberine, Danshensu (Salvianic acid A), Epigallocatechin gallate, Quercetin, Resveratrol, Sarsasapogenin, Barley (Hordeum vulgare), Intellect plant (Celastrus paniculatus), Japanese pepper tree (Zanthoxylum piperitum), Kava (Piper methysticum), Rose root (Rhodiola rosea), Saponins (Triterpene glycosides), Cacao (Theobroma cacao), Lion’s Mane (Hericium erinaceus), St. John’s Wart (Hypericum perforatum), Coconut Oil (Cocos nucifera.) and palm oil, such as palm kernel oil or African Palm Tree Oil (Elaeis guineensis). In other embodiments, the potentiating agent may be derived from a non-botanical source, such as Estrogen (Estrodiol), Casei (Lactobacillus casei), Rhamnosus (Lactobacillus rhamnosus), Progesterone (Pregn-4- ene-3, 20-dione), SAMe (S-adenosyl-L-methionine), Selenium, Vitamin D (calciferol), and Zinc (zinc sulfate). In some embodiments, the potentiating agent may be synthetic, such as a monoamine oxidase inhibitor. The potentiating agent may be in the form of a powder, extract, oil, crystal, or other suitable form.

[0044] The pharmaceutical composition may further comprise one or more stabilizers, preservatives, fillers, and/or carriers, which include any known pharmaceutically-acceptable substance or combination thereof.

[0045] The present pharmaceutical composition can be in a form suitable for oral administration, such as, but are not limited to, tablets, pills, troches, lozenges, powders, emulsions, capsules, suspensions, syrups, drops, sprays, tinctures, and films. The pharmaceutical composition may be swallowed, orally disintegrating, chewable, or configured for sublingual or buccal administration. In some embodiments, the pharmaceutical composition may be configured for use in beverages or food, such as in tea, gummies, or chocolate.

[0046] The present pharmaceutical composition and kit can be used in psychedelic-assisted therapy.

[0047] The present pharmaceutical composition and kit can be used to treat mental and physical health disorders including but not limited to major depressive disorder, treatment resistant depression, depression, anxiety, generalized anxiety disorder, body dysmorphia, pain, chronic pain, cluster headaches, migraines, trauma, PTSD, end of life grief (those dying and those close to them), ADHD, OCD, substance use disorders, colour blindness, and traumatic brain injury.

[0048] In some embodiments, the pharmaceutical composition and one or more of the other substances described herein may be contained in a form suitable for sustained, delayed, or timed release, such as in nested or twinned capsules, which may be comprised of gelatin, mycelium-derived chitin, or any other known pharmaceutically-acceptable substance or combination thereof. In some embodiments, the pharmaceutical composition may be contained in a solid oral dosage form comprising one or more particles, each comprising one or more of an immediate release layer, a sustained release layer, and a delayed release layer, configured for one or more of the immediate release of one or more substances, the sustained release of one or more substances, and the delayed release of one or more substances. In some embodiments, the pharmaceutical composition may be contained in an osmotic delivery vehicle, such as an osmotic pump delivery tablet. In other embodiments, the pharmaceutical composition and one or more of the other substances described herein may be contained in an osmotic delivery vehicle.

[0049] In other embodiments, nanophytomedicine delivery methods may be employed. While not wishing to be bound by any particular theory or mode of action, utilization of nanotechnology may allow multiple substances with different properties to be used in the same composition, may change a substance’s properties and behaviour in a biological environment, and may control and modify the overall properties of one or more substances in the composition. Nanotechnology may ameliorate limitations encountered with plant or animal extracts while also potentiating the therapeutic effects of same by improving solubility and bioavailability, safeguarding against toxicity, enhancing pharmacological activity, improving of stability, increasing tissue macrophage distribution, sustaining delivery, and/or protecting substances from physical and chemical degradation. Nanophytomedicine delivery methods may include nanoparticles, including but not limited to solid lipid nanoparticles, polymeric nanoparticles, poly(lactic-co-glycolic) nanospheres, polylactic acid nanospheres, graphene nanoparticles, solid drug nanoparticles, magnetic nanoparticles, metal and/or other inorganic nanoparticles, sillica nanoparticles, and mesoporous sillica nanoparticles, nanospheres, nanosuspension, nanostructured lipid carriers, liquid crystal systems, microemulsions, selfmicroemulsifying drug delivery systems, liposomes, colloidal nano-liposomes, niosomes, vesosomes, phytosomes, polymersomes, polymeric micelles, phospholipid micelles, nanogels, hydrophobically modified glycol chitosan, dendrimers, carbon nanotubes, drug nanocrystals, and quantum dots. [0050] Such nanophytomedicine delivery methods may be produced using any known method, including but not limited to the following methods: high pressure homogenization, complex coacervation, co-precipitation, salting out, nanoprecipitation, solvent displacement, solvent emulsification-diffusion, supercritical fluid, self-assembly, quasi-emulsion-solvent- diffusion, solid/oil/water emulsion solvent evaporation, cation-induced, controlled gelation, ionic gelation, emulsion polymerization, dialysis, wet-milling, solvent evaporation, adsorption equilibrium, and microfluidic mixing. The surface the substances produced using such methods may be coated with surfactants and/or polymers, such as but not limited to hydrophilic polymers/surfactants, stabilizing polymers/surfactants, mucoadhesive polymers/surfactants, and biodegradable copolymers with hydrophilic segments.

[0051] Also described are methods for processing psychedelic compounds contained in the present pharmaceutical composition from the psychedelic compound source. In some embodiments, the psychedelic compound source may be soaked in a citric acid bath. While not wishing to be bound by any particular theory or mode of action, a citric acid bath may break down the walls of the biomaterial containing the psychedelic compound, thereby increasing the bioavailability of the psychedelic compound(s). For example, the method may include desiccating and drying a psilocybin-containing mushroom and then pulverizing it into a powder, which is then submerged in a citric acid bath for approximately 30 minutes. The citric acid is then evaporated to bring the substance back to a dried powdered form with subtle heat and airflow.

[0052] Also described is a method for producing mycelium-derived chitin capsules. Such capsules may be prepared using mycelium-derived chitinous thin film. In some embodiments, the mycelium may be derived from psilocybin-containing mushrooms. While not wishing to be bound by any particular theory or mode of action, mycelium-derived chitinous, as a naturally occurring plant-based substance, is non-toxic, has low allergenicity, and may be preferable for users who do not wish to, or cannot, consume animal or fish by-products, as is found in standard gelatin capsules. In addition, its cationic properties allow it to interact with negatively charged cell membranes, which may enhance cellular uptake, thereby enhancing drug absorption and prolonging the residence time of the drug, improving its bioavailability. In some embodiments, chitinous thin film is produced by dissolving the cell walls using methods known in the art, after which the material is pressed and rolled. The thin film may then be formed into capsules, including but not limited to being dipped, pressed on or in molds, or sprayed or poured into or onto a mold. [0053] Also described is a dosing schedule for the present pharmaceutical composition. In one embodiment, the psychedelic compound(s) is administered simultaneously with the other components of the composition. In other embodiments, the psychedelic compound(s) is administered at a different time than the other components of the composition, such that the psychedelic compound(s) may be administered before or after the other components of the composition.

[0054] Also described is a pharmaceutical kit comprising the present pharmaceutical composition and one or more agent that can mediate the effects of the psychedelic compounds. This may include those effects users may experience contemporaneously with the use of the psychedelic compounds. This may also include effects users may experience after use of the psychedelic compounds, such as Hallucinogen-persisting perception disorder (HPPD), commonly known as “flashbacks” in which a user experiences some or all of the psychedelic experience after use of the psychedelic compounds.

[0055] While not wishing to be bound by any particular theory or mode of action, the agent may reverse or diminish the effects of the present psychedelic pharmaceutical composition acting as an “antidote” to some or all of the psychedelic experience. Suitable antidote agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can reduce or eliminate the effects of one or more psychedelic compounds. In some embodiments, the antidote agent may be derived from a botanical source, such as African Potato (Hypoxis hemerocallidea), African Wormwood (Artemisia afra), Amla (Indian gooseberry), Ashwagandha (Withania somnifera), Bee Balm or Monarda (Wild Bergamot Herb), Blue Skullcap (Scutellaria lateriflora), Bracted Vervain (Verbena bracteate), and/or Blue Vervain, Verbena hastata), and/or European Vervain (Verbena officinalis), Bupleurum Powder to Spread the Liver or Bupleurum and Cyperus Formula (Chaihu shugansan), (TCM Composition), California Mugwort (Artemisia douglasiana), California Poppy (Eschscholzia californica), California Tree Poppy or Tree Poppy (Dendromecon rigida), Calming and Purging Powder (Kaixinsan), Camphor Tree (Cinnamomum camphora), Cape Tephrosia (Tephrosia capensis), Cape-Myrtle (Maerua angolensis), Cardamom (Elettaria cardamomum), Chaihu (Bupleurum), hamomile (Matricaria chamomilla), Chinese Thornapple or Fierce Thornapple (Datura ferox L.), Chinese Thorowax (Bupleurum chinense), Chinese Skullcap (Scutellaria baicalensis), Churna (Ayurvedic remedy composition), Citronella Grass (Cymbopogon nardus), Corn Chamomile (Anthemis arvensis L.), Curcumin (Curcuma longa), Echinacea (Echinacea purpurea), Eleutherococcus (Eleutherococcus senticosus), False Daisy (Bhringaraj), False Pepper Tree (Schinus molle L.), Fennel (Foeniculum vulgare), Garden Angelica (Angelica archangelica), Gardenia Fruit (Gardeniae fructus), Giant Alepidea (Alepidea amatymbica), Ginkgo or Maidenhair Tree (Ginkgo Biloba), Golden Shower (Galphimia Glauca), Gotu Kola (Centella asiatica), Hawthorn (Crataegus monogyna Jacq.), Hops (Humulus lupulus L), Houpu Magnolia (Magnolia officinalis), Indian Pennywort (Centella asiatica), Jimsonweed or Common Thornapple (Datura stramonium L), Jujube date (Ziziphus jujuba), Kanna (Sceletium tortuosum), Kava (Piper methysticum), Lavender (Lavandula spp.), Lemon Balm (Melissa officinalis), Lemon Verbena (Aloysia citrodora), Lesser Calamint (Clinopodium nepeta), Licorice or Glycyrrhiza (Ganmaidazao), (TCM decoction), Liquorice Root (Glycyrrhiza), Maidenhair Fern (Adiantum capillus-veneris), Marshmallow (Althaea officinalis), Mexican Skullcap (Scutellaria exicana), Mexican Tarragon (Tagetes lucida), Milk Thistle (Silybum marianum), Milkweed (Asclepias), Morus (Morus spp.), Motherwort (Leonurus cardiaca), Motherwort Root (Leonurus japonicus), Nettle (Urtica dioica), Nutmeg (Myristica fragrans), Oregano (Origanum vulgare), Passionflower (Passiflora incarnata), Paw Paw (Asimina triloba), Peppermint (Mentha piperita), Periwinkle (Catharanthus roseus), Pineilia and Magnolia Decoction (Banxia houpo), (TCM decoction), Pinkroot (Spigelia marilandica), Prickly Ash (Zanthoxylum americanum), Passion Vine (Passiflora incarnata), Radix Ophiopogonis (Ophiopogon root), Ribwort Plantain (Plantago lanceolata), Rhodiola (Rhodiola rosea), Rock Rose (Cistus incanus), Rosemary (Rosmarinus officinalis), Rue (Ruta graveolens), Saussurea (Saussurea spp.), Saw Palmetto (Serenoa repens), Scullcap (Scutellaria), Self Heal (Prunella vulgaris), Senega (Polygala senega), Sensitive Plant (Mimosa pudica), Serratula (Serratula spp.), Shen Jin Cao (Lycopodium serratum), (TCM: herb), Skullcap (Scutellaria), Spikenard (Jatamansi), Spilanthes (Spilanthes spp.), St. John's Wort (Naughty Man's Plaything), (Hypericum perforatum), Stone Root (Collinsonia canadensis), Sweet Annie (Artemisia annua), Sweet Marjoram (Origanum majorana), Thyme (Thymus vulgaris), Tinnevelly Senna (Cassia angustifolia), Jia Wei Zhenzhu An Chuang Wan, Kamishoyosan, Turmeric (Curcuma longa), Uva Ursi (Artemisia uva-ursi, bearberry, kinnikinnick), Valence or Valerian (Valeriana officinalis), Valerian Root (Valeriana jatamansi), Vervain (Verbena officinalis), Violet (Viola spp.), Vervain (Verbena officinalis), Water Hyssop (Brahmi), Western Skunk Cabbage (Lysichiton americanum), White Willow (Salix alba), Wild Lettuce (Lactuca virosa), Wild Yam (Dioscorea villosa), Wood Betony (Stachys officinalis), Wood Sage (Teucrium scorodonia), Woodruff (Galium odoratum), Wormseed (Artemisia cina), Wormwood (Artemisia absinthium), Yarrow (Achillea millefolium), Yerba Santa (Eriodictyon californicum), Yohimbe (Pausinystalia yohimbe), and Zedoary (Curcuma zedoaria). In other embodiments, the antidote agent may be a mineral, such as calcium, a hormone, such as melatonin, or a vitamin, such as Niacin (Vitamin B3). In some embodiments, the antidote agent may be synthetic. [0056] In some embodiments, the antidote agent may be a benzodiazepine, such as lorazepam and clonazepam, an antipsychotic, such as Quetiapine, Olanzapin, Risperidone and Haloperidol, a sedative, such as ethanol (Aethanolum), an anti-serotonergic agent, such as 5-HTP (5-hydroxytryptophan), Chasteberry (Vitex agnus-castus), L-Dopa (l-3,4- dihydroxyphenylalanine), L-Lysine ((2S),-2,6-Diaminohexanoic acid), L-Tryptophan ((2S),-2- amino-3-(1 H-indol-3-yl), propanoic acid), -Tyrosine (L-2-Amino-3-(4-hydroxyphenyl), propanoic acid), Omega-3 (Eicosapentaenoic acid, docosahexaenoic acid), Saccharomyces boulardii, SAMe (S-adenosyl-L-methionine), Shilajit (Mumiyo-saladji), Valerian (Valeriana officinalis), Vitamin B (Pyridoxine, folate, cobalamin), and Yohimbe bark extract (Corynanthe johimbe), or a pro-GABA substance, such as Apigenin (4', 5, 7, -trihydroxyflavone), Ashwagandha (Withania somnefera), Black seed oil (Nigella sativa), Cussonia (Cussonia zimmermannii), Green tea (Camellia sinensis), Jasmine (Jasminum officinale), Kava (Piper methysticum), Lavender (Lavandula), Lemon balm (Melissa officinalis), L-Theanine (L-y- glutamylethylamide), Magnesium (Magnesium citrate), Magnolia Bark (magnolia officinalis), Nut grass (Cyperus rotundus), Red sage (Salvia miltiorhiza), Skullcap herbs (Scutellaria baicalensis, Scutellaria lateriflora), Taurine (2-aminoethanesulfonic acid), Valerian (Valeriana officinalis), Vitamin B6 (Pyridoxine), Zeoary (Curcuma zedoaria), and Zinc (Zinc sulfate). In other embodiments, the antidote agent may be Mirtazapine, Ketanserin, Zopiclone, Diazepam, or MDMA.

[0057] In other embodiments, the kit may include other compositions comprised of one or more agents which may reduce or diminish unwanted side effects experienced by users ingesting the present psychedelic pharmaceutical composition, such as nausea, gastrointestinal distress, anxiety, Restless Leg Syndrome, tachycardia, so-called “ego dissolution”, muscle weakness, and/or shaking/tremors. Such other compositions may include agents which may address each side-effect individually (e.g., an agent or composition of agents specifically and exclusively for nausea which may be taken in the event a user experiences nausea or prior if a user is known to be prone to nausea or not taken if the user is unconcerned by nausea or if the user is seeking to determine if the psychedelic composition may cause nausea or not). Suitable agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can reduce or diminish unwanted side effects of one or more psychedelic compounds, including but not limited to the antiemetic agents or agents to reduce gastro-intestinal distress, anxiety, Restless Leg Syndrome, tachycardia, “ego dissolution”, muscle weakness, and shaking or tremors described herein. Such agents may be ingested prior to, jointly, or after ingestion of the psychedelic composition and/or any other related agents or compositions. [0058] In some embodiments, the kit may include an agent to alter the flavour, aroma, or colour of the present psychedelic pharmaceutical composition, which users can add to the present psychedelic pharmaceutical composition to reduce the user’s aversions to the composition and which may assist in creating a positive experience for the user. Suitable agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can produce a desired flavour, aroma, or colour, including but not limited to the flavouring agents, aromatic agents, and colouring agents described herein.

[0059] In other embodiments, the kit may contain agents or compositions of agents that may be ingested independently to enhance or potentiate the effects of the present psychedelic pharmaceutical composition (i.e., a user may elect to potentiate their dose of psychedelic compound or not). Suitable agents to enhance or potentiate the effects of the previously- ingested psychedelic compound(s) contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can enhance the effects of one or more psychedelic compounds, including but not limited to the potentiating agents described herein.

[0060] Also described is a schedule for the present pharmaceutical kit. In one embodiment, the psychedelic compound(s) is administered simultaneously with the one or more agents. In other embodiments, the psychedelic compound(s) is administered at a different time than the agent(s) or other compositions, such that the psychedelic compound(s) may be administered before, jointly, or after the other agent(s) or composition(s).

[0061] While not wishing to be bound by any particular theory or mode of action, the user’s mindset and their surroundings may impact the user’s overall experience. In some embodiments, the pharmaceutical kit may include information, recommendations, methods and procedures designed to assist the user in preparing for, navigating during and following up on after the psychedelic experience. Such information may include, among other things, screening guidelines and tools for the use of psychedelic compounds, dietary guidance leading up to the experience, best practices for preparing a users mind, body and surroundings for the experience, planning tools for scheduling the experience and any subsequent experience(s), record keeping advice for documenting and/or sharing the experience, safety tips, integration processes, progress tracking and reporting resources.

[0062] In some embodiments, the pharmaceutical kit comprises more than one pharmaceutical composition as described herein to provide users with a selection of pharmaceutical compositions and/or doses of psychedelic compound(s) in the pharmaceutical compositions. In some embodiments, the kit may include different doses of the same psychedelic compound or composition in varying potencies so that a user may explore the effectiveness of different dosages at different times. For example, a user may wish to begin with a small test dose to gauge their reaction to the composition prior to ingesting a larger dose or may wish to follow a larger dose with a regimen of smaller doses commonly referred to as ’’microdosing”. In some embodiments, the kit may include multiple doses of the same psychedelic compound or composition of the same potency which may be used as a “booster” dose to be taken shortly after the first dose should the first dose prove to be insufficient. In other embodiments, the kit may contain multiple doses of different psychedelic compounds or compositions so that users may compare the experiences, effectiveness and side effects of different compounds.

[0063] In some embodiments, the pharmaceutical kit comprises one or more tests (both chemical assay based and questionnaire based) designed to, amongst other things, assist users in determining their readiness for the psychedelic experience, their potential preference of psychedelic compound, and/or their likelihood of positive or negative reactions to the composition(s).

[0064] In some embodiments, the kit may include devices and instructions related to light therapy. Light therapy may assist in enhancing the psychedelic experience and reduce the side effects associated with use of psychedelics. While not wishing to be bound by any particular theory or mode of action, light therapy may act to increase blood flow, reduce inflammation, and/or contribute to mitochondrial repair, which may impact the psychedelic experience. The kit may include Red Light Therapy and/or Blue Light Therapy delivery mechanisms including but not limited to masks, hoods, shrouds, caps, and lamps. In some embodiments the kit may include certain light blocking devices, such as goggles, masks, or glasses tinted to block green light.

[0065] While this invention has been described with reference to illustrative embodiments and examples, the description is not intended to be construed in a limiting sense. Thus, various modifications of the illustrative embodiments, as well as other embodiments of the invention, will be apparent to persons skilled in the art upon reference to this description. It is therefore contemplated that the appended claims will cover any such modifications or embodiments.

[0066] All publications, patents and patent applications referred to herein are incorporated by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference in its entirety.

Claims

What is claimed is:

1. A pharmaceutical composition comprising one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and one or more of the following:

(a) one or more alkaloid;

(b) material from one or more non-psilocybin-containing mushroom;

(c) one or more cannabinoid;

(d) one or more terpene;

(e) one or more flavonoid;

(f) one or more flavouring agent;

(g) one or more aromatic agent;

(h) one or more colouring agent;

(i) one or more antiemetic agent;

(j) one or more agent to reduce gastro-intestinal distress;

(k) one or more agent to reduce anxiety;

(l) one or more agent to reduce Restless Leg Syndrome;

(m) one or more agent to alleviate tachycardia;

(n) one or more potentiating agent;

(o) one or more glutamate modulating agent;

(p) one or more agent to reduce muscle weakness; and

(q) one or more agent to reduce shaking or tremors.

2. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and one of components (a) - (q).

3. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and two of components (a) - (q).

4. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and three of components (a) - (q).

5. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and four of components (a) - (q).

6. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and five of components (a) - (q).

7. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and six of components (a) - (q).

8. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and seven of components (a) - (q).

9. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and eight of components (a) - (q).

10. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and nine of components (a) - (q).

11. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and ten of components (a) - (q).

12. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and eleven of components (a) - (q).

13. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and twelve of components (a) - (q).

14. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and thirteen of components (a) - (q).

15. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and fourteen of components (a) - (q).

16. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and fifteen of components (a) - (q).

17. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and sixteen of components (a) - (q).

18. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises one or more psychedelic compound, such as psilocybin from at least one psilocybin-containing mushroom, and each of components (a) - (q).

19. Use of the pharmaceutical composition of any one of claims 1 to 18 in psychedelic- assisted therapy.

20. Use of the pharmaceutical composition of any one of claims 1 to 18 to treat a mental or physical health disorder.

21. A delivery method for the pharmaceutical composition of any one of claims 1 to 18 comprising nanotechnology.

22. A method of producing mycelium-derived chitin capsules for the pharmaceutical composition of any one of claims 1 to 18.

23. A pharmaceutical kit comprising a pharmaceutical composition comprising one or more psychedelic compounds, such as psilocybin, and one or more agents that can mediate the effects of the psychedelic compounds.

24. The pharmaceutical kit of claim 21 , wherein the kit further comprises a light therapy delivery mechanism.

25. A method of producing mycelium-derived chitin capsules for a pharmaceutical composition.