BACKGROUND OF THE INVENTION

In certain jurisdictions, ayahuasca-like substances and other psychedelic medicines are being legalized or decriminalized, hence allowing for breakthrough alternative medicines and/or recreational experiences. Psychedelic research is still in its infancy, which in part is a consequence of legal barriers to such research that has existed for decades. Yet preliminary reports are encouraging. For example, it was recently reported that dimethyltryptamine, which is the active ingredient in ayahuasca, can promote the proliferation of neural stem cells and subsequent neurogenesis, thus leading to improvements in memory. Such results have significant implications for neurodegenerative disorders such as Alzheimer's, Parkinson's, and dementia (Morales-Garcia et al.,Translational Psychiatry,10:331 (2020)).

However, the ability to distribute reliably consistent amounts and types of ayahuasca-like substances having a particular level of therapeutic or recreational quality is limited. Safety concerns may also arise when ayahuasca-like substances are obtained in a manner where the exact composition is unknown due to risks of contamination, tampering, misrepresentation, etc.

The ability to store and seal a dose-specific vaporizable formulation comprising an ayahuasca-like substance in a controlled environment with a labelled package that is easily portable provides a tremendous benefit to patients and other consumers. When an ayahuasca-like substance comes pre-processed and stored in a dry, secure, contamination-free environment, a patient or other consumer is provided with a level of confidence and convenience that has not previously been available. The devices and methods of the present invention thus solve problems associated with both ease of use and safety, and further provide a greater degree of legitimacy so that a patient or consumer can be confident that the contents of the packaged product is in fact what is listed by the labelling.

The invention described herein provides a device, formulation, methods of use, methods of treatment of psychological disorders, and kits for the delivery of ayahuasca-like substances, which has significant commercial and medicinal potential in jurisdictions that have legalized or decriminalized psychedelic substances.

SUMMARY OF THE INVENTION

The present teachings relate to a system for the delivery of a vaporizable formulation comprising an ayahuasca-like substance.

In an embodiment, a device for the delivery of an ayahuasca-like substance is provided. The device comprises a chamber comprising at least one vaporizable formulation wherein the vaporizable formulation comprises the ayahuasca-like substance. In an embodiment, the chamber of the device comprises a top portion adapted for coupling to a mouthpiece wherein the top portion of the chamber comprises at least one aperture adapted to permit flow of air, liquid, solids, or vapor between the top portion of the chamber and the mouthpiece. In an embodiment, a mouthpiece of the device coupled to the top portion of the chamber is provided wherein the mouthpiece comprises a top aperture, a central open bore, a bottom portion comprising an aperture, and wherein the bottom portion of the mouthpiece is coupled to the top portion of the chamber. In an embodiment, at least one seal situated between the bottom portion of the mouthpiece of the device comprising an aperture and the top portion of the chamber is provided. In an embodiment, the mouthpiece of the device is releasably coupled to the top portion of the chamber. In an embodiment, the mouthpiece of the device is lockably coupled to the top portion of the chamber. In an embodiment, the chamber of the device comprises a bottom portion adapted for coupling to a power unit capable of providing power to vaporize the vaporizable formulation. In an embodiment, the chamber of the device is coupled to the power unit capable of providing power to vaporize the vaporizable formulation. In an embodiment, the chamber of the device is releasably coupled to the power unit. In an embodiment, the chamber of the device is lockably coupled to the power unit. In an embodiment, the chamber of the device comprises one or more of a 401, 510, 601, 610, 710, 808, 901, 4081, CE-4, CE-5, E9, or eGo connector. In an embodiment, the chamber of the device comprises a 510 connector. In an embodiment, the chamber of the device is transparent to permit visualization of levels of the vaporizable formulation. In an embodiment, the chamber of the device is refillable. In an embodiment, the ayahuasca-like substance or vaporizable formulation of the device comprises one or more of dimethyltryptamine, a monoamine oxidase inhibitor, 5-methoxy-N,N-dimethyltryptamine, or 2-5-dimethoxy-4-bromophenethylamine. In an embodiment, the ayahuasca-like substance of the device comprises dimethyltryptamine. In an embodiment, the ayahuasca-like substance of the device comprises an isotopomer or isotopologue of one or more of dimethyltryptamine, a monoamine oxidase inhibitor, 5-methoxy-N,N-dimethyltryptamine, or 2-5-dimethoxy-4-bromophenethylamine. In an embodiment, the ayahuasca-like substance of the device is dimethyltryptamine comprising deuterium. In an embodiment, the vaporizable formulation of the device comprises one or more of propylene glycol (PG), vegetable glycerin (VG), or polyethylene glycol (PEG).

In another embodiment, a method for delivering an ayahuasca-like substance is provided. In this embodiment the method comprises heating a vaporizable formulation comprising the ayahuasca-like substance to vaporize at least a portion of the vaporizable formulation. In an embodiment, the vaporizable formulation of the method is housed in a chamber comprising a top portion adapted for coupling to a mouthpiece wherein the top portion of the chamber comprises at least one aperture adapted to permit flow of air, liquid, solids, or vapor between the top portion of the chamber and the mouthpiece. In an embodiment, the chamber of the method comprises a mouthpiece coupled to the top portion of the chamber wherein the mouthpiece comprises a top aperture, a central open bore, a bottom portion comprising an aperture, and wherein the bottom portion of the mouthpiece is coupled to the top portion of the chamber. In an embodiment, the chamber of the method comprises at least one seal situated between the bottom portion of the mouthpiece comprising an aperture and the top portion of the chamber. In an embodiment, the mouthpiece of the method is releasably coupled to the top portion of the chamber. In an embodiment, the mouthpiece of the method is lockably coupled to the top portion of the chamber. In an embodiment, the chamber of the method comprises a bottom portion adapted for coupling to a power unit capable of providing power to vaporize the vaporizable formulation. In an embodiment, the chamber of the method is coupled to the power unit capable of providing power to vaporize the vaporizable formulation. In an embodiment, the chamber of the method is releasably coupled to the power unit. In an embodiment, the chamber of the method is lockably coupled to the power unit. In an embodiment, the chamber of the method comprises one or more of a 401, 510, 601, 610, 710, 808, 901, 4081, CE-4, CE-5, E9, or eGo connector. In an embodiment, the chamber of the method comprises an eGo connector. In an embodiment, the chamber of the method comprises a 510 connector. In an embodiment, the chamber of the method is refillable. In an embodiment, the chamber of the method is single-use. In an embodiment, the chamber of the method is transparent to permit visualization of levels of the vaporizable formulation. In an embodiment, the ayahuasca-like substance or vaporizable formulation of the method comprises one or more of dimethyltryptamine, a monoamine oxidase inhibitor, 5-methoxy-N,N-dimethyltryptamine, or 2-5-dimethoxy-4-bromophenethylamine. In an embodiment, the ayahuasca-like substance of the method comprises dimethyltryptamine. In an embodiment, the ayahuasca-like substance of the method comprises an isotopomer or isotopologue of one or more of dimethyltryptamine, a monoamine oxidase inhibitor, 5-methoxy-N,N-dimethyltryptamine, or 2-5-dimethoxy-4-bromophenethylamine. In an embodiment, the ayahuasca-like substance of the method is dimethyltryptamine comprising deuterium. In an embodiment, the vaporizable formulation of the method comprises one or more of propylene glycol (PG), vegetable glycerin (VG), or polyethylene glycol (PEG).

In another embodiment, a vaporizable formulation is provided. In this embodiment the vaporizable formulation comprises an ayahuasca-like substance. In an embodiment, the ayahuasca-like substance or vaporizable formulation comprises one or more of dimethyltryptamine, a monoamine oxidase inhibitor, 5-methoxy-N,N-dimethyltryptamine, or 2-5-dimethoxy-4-bromophenethylamine. In an embodiment, the ayahuasca-like substance of the vaporizable formulation comprises dimethyltryptamine. In an embodiment, the ayahuasca-like substance of the vaporizable formulation comprises an isotopomer or isotopologue of one or more of dimethyltryptamine, a monoamine oxidase inhibitor, 5-methoxy-N,N-dimethyltryptamine, or 2-5-dimethoxy-4-bromophenethylamine. In an embodiment, the ayahuasca-like substance of the vaporizable formulation is dimethyltryptamine comprising deuterium. In an embodiment, the vaporizable formulation comprises one or more of propylene glycol (PG), vegetable glycerin (VG), or polyethylene glycol (PEG).

In another embodiment, a method of treating a psychological disorder is provided. In this embodiment the method comprises administering to a patient an effective amount of an ayahuasca-like substance, wherein the method comprises heating a vaporizable formulation comprising the ayahuasca-like substance to vaporize at least a portion of the vaporizable formulation. In an embodiment, the vaporizable formulation of the method of treatment is housed in a chamber comprising a top portion adapted for coupling to a mouthpiece wherein the top portion of the chamber comprises at least one aperture adapted to permit flow of air, liquid, solids, or vapor between the top portion of the chamber and the mouthpiece. In an embodiment, the chamber of the method of treatment comprises a mouthpiece coupled to the top portion of the chamber wherein the mouthpiece comprises a top aperture, a central open bore, a bottom portion comprising an aperture, and wherein the bottom portion of the mouthpiece is coupled to the top portion of the chamber. In an embodiment, the chamber of the method of treatment comprises at least one seal situated between the bottom portion of the mouthpiece comprising an aperture and the top portion of the chamber. In an embodiment, the mouthpiece of the method of treatment is releasably coupled to the top portion of the chamber. In an embodiment, the mouthpiece of the method of treatment is lockably coupled to the top portion of the chamber. In an embodiment, the chamber of the method of treatment comprises a bottom portion adapted for coupling to a power unit capable of providing power to vaporize the vaporizable formulation. In an embodiment, the chamber of the method of treatment is coupled to the power unit capable of providing power to vaporize the vaporizable formulation. In an embodiment, the chamber of the method of treatment is releasably coupled to the power unit. In an embodiment, the chamber of the method of treatment is lockably coupled to the power unit. In an embodiment, the chamber of the method of treatment comprises one or more of a 401, 510, 601, 610, 710, 808, 901, 4081, CE-4, CE-5, E9, or eGo connector. In an embodiment, the chamber of the method of treatment comprises an eGo connector. In an embodiment, the chamber of the method of treatment comprises a 510 connector. In an embodiment, the chamber of the method of treatment is refillable. In an embodiment, the chamber of the method of treatment is single-use. In an embodiment, the chamber of the method of treatment is transparent to permit visualization of levels of the vaporizable formulation. In an embodiment, the ayahuasca-like substance or vaporizable formulation of the method of treatment comprises one or more of dimethyltryptamine, a monoamine oxidase inhibitor, 5-methoxy-N,N-dimethyltryptamine, or 2-5-dimethoxy-4-bromophenethylamine. In an embodiment, the ayahuasca-like substance of the method of treatment comprises dimethyltryptamine. In an embodiment, the ayahuasca-like substance of the method of treatment comprises an isotopomer or isotopologue of one or more of dimethyltryptamine, a monoamine oxidase inhibitor, 5-methoxy-N,N-dimethyltryptamine, or 2-5-dimethoxy-4-bromophenethylamine. In an embodiment, the ayahuasca-like substance of the method of treatment is dimethyltryptamine comprising deuterium. In an embodiment, the vaporizable formulation of the method of treatment comprises one or more of propylene glycol (PG), vegetable glycerin (VG), or polyethylene glycol (PEG). In an embodiment, the psychological disorder of the method of treatment comprises one or more of obsessive compulsive disorder, nicotine addiction, alcoholism, narcotic addiction, depression and anxiety related to diagnosis of a life-threatening or terminal illness, major depressive disorder, depression, bipolar disorder, dysthymic disorder, panic attacks, schizophrenia, attention deficit disorder, attention deficit hyperactivity disorder, general anxiety disorder, impulse disorders, delusional disorders, cluster headaches, migraines, personality disorders, gambling disorders, eating disorder, body dysmorphic disorder, or post traumatic stress disorder.

In another embodiment, a kit is provided. The kit comprises a chamber comprising at least one vaporizable formulation wherein the vaporizable formulation comprises an ayahuasca-like substance. In an embodiment, the chamber of the kit comprises a mouthpiece coupled to the top portion of the chamber wherein the mouthpiece comprises a top aperture, a central open bore, a bottom portion comprising an aperture, and wherein the bottom portion of the mouthpiece is coupled to the top portion of the chamber. In an embodiment, the mouthpiece of the kit is releasably coupled to the top portion of the chamber. In an embodiment, the mouthpiece of the kit is lockably coupled to the top portion of the chamber. In an embodiment, the chamber of the kit is coupled to the power unit capable of providing power to vaporize the vaporizable formulation. In an embodiment, the chamber of the kit is releasably coupled to the power unit. In an embodiment, the chamber of the kit is lockably coupled to the power unit. In an embodiment, the chamber of the kit comprises one or more of a 401, 510, 601, 610, 710, 808, 901, 4081, CE-4, CE-5, E9, or eGo connector. In an embodiment, the chamber of the kit comprises a 510 connector. In an embodiment, the chamber of the kit is transparent to permit visualization of levels of the vaporizable formulation. In an embodiment, the chamber of the kit is refillable. In an embodiment, the ayahuasca-like substance or vaporizable formulation of the kit comprises one or more of dimethyltryptamine, a monoamine oxidase inhibitor, 5-methoxy-N,N-dimethyltryptamine, or 2-5-dimethoxy-4-bromophenethylamine. In an embodiment, the ayahuasca-like substance of the kit comprises dimethyltryptamine. In an embodiment, the ayahuasca-like substance of the kit comprises an isotopomer or isotopologue of one or more of dimethyltryptamine, a monoamine oxidase inhibitor, 5-methoxy-N,N-dimethyltryptamine, or 2-5-dimethoxy-4-bromophenethylamine. In an embodiment, the ayahuasca-like substance of the kit is dimethyltryptamine comprising deuterium. In an embodiment, the vaporizable formulation of the kit comprises one or more of propylene glycol (PG), vegetable glycerin (VG), or polyethylene glycol (PEG).

