Systems and methods for an RNA-adjunct psychedelic therapy

Abstract

A method of treating a patient with a mental health condition. The method includes conducting a psychological assessment to verify the patient's suitability for RNA-Adjunct Psychedelic Therapy (RAPT). The method also includes educating the patient about RAPT. The method further includes administering RNA therapy to the patient. The method also includes administering psychedelic therapy to the patient. The method further includes administering post session integration.

Description

SYSTEMS AND METHODS FOR AN RNA-ADJUNCT PSYCHEDELICTHERAPYCROSS-REFERENCE TO RELATED APPLICATION

[0001] This is an International Patent Application claiming priority to and the benefit of U.S. Patent Application No. 63 / 587,867. filed 4 October 2023, which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] The present disclosure relates generally to systems and methods for psychedelic therapy and, more specifically, to a next generation hybrid psychedelic therapy which incorporates the use of psychedelic analogs, therapeutic protocols and RNA therapies.BACKGROUND

[0003] Unlike typical psychiatric medications that require chronic administration, studies that have administered psychedelics show significant clinical benefits lasting up to 6 months. The effectiveness of psychedelic therapies after a single or several administrations represents a substantial advantage over commonly used antidepressants and anxiolytics that require daily administration. Similarly, RNA cognitive therapy is a single dose behavior modification approach that side steps chronic administration and adherence problems.

[0004] Although effective pharmacotherapies for depression and anxiety are available, these drugs have limited efficacy, produce adverse effects, and are associated with patient adherence problems. Antidepressant medications confer substantial problematic effects (e g., suicidal ideation, decrease in sexual drive, infertility7, and weight gain). Although many patients with depression and anxiety7showed reduced or remitted symptoms after treatment with existing pharmacotherapies, approximately 30% to 50% of patients do not respond fully, and as many as 10% to 30% of patients are considered treatment-resistant. Together, the resulting average effects are only modestly larger than the effects of placebo.

[0005] Psychedelic therapy for depression and PTSD has a significant relapse rate and is typically only effective for 6 months.SUMMARY

[0006] The overall aim of the methods described herein is to provide a method for combining psychedelic therapy with RNA therapy to improve efficacy and results. One aspect of this disclosure is related to methods of treating patient with mental health conditions. These methods may include conducting a psychological assessment to verify the patient's suitability for RNA-Adjunct Psychedelic Therapy (RAPT). These methods may also include educating the patient about RAPT. Further, these methods may further include administering RAPT to the patient. These methods may also include administering psychedelic therapy to the patient. These methods may further include administering postsession integration to the patient.

[0007] Therapeutic observation suggests that psychedelics alter retrieval, processing, and reconsolidation of memories such as those related to trauma, addiction, anxiety', and depression. However, frequently reported patient anxiety and resistance to psychedelic therapeutic interventions can be mitigated by the novel RNA Adjunct Psychedelic Therapy (RAPT) invention described herein. RAPT combines the two most efficient and promising next generation approaches for improving mental health - psychedelic therapy and RNA cognitive therapy - into a hybrid treatment protocol with synergistic results.

[0008] The foregoing has outlined rather broadly several features and technical advantages of examples of this disclosure so that the detailed description that follows maybe better understood. Additional features and advantages will be described hereinafter. The concepts and specific examples disclosed herein may- be readily utilized as a basis for modifying or designing other methods, constructs and / or systems for carrying out the same or similar purposes of the present disclosure. Such equivalent constructions do not depart from the spirit and scope of the appended claims. Features which are believed to be characteristic of the concepts disclosed herein, both as to their organization and method of operation, together with associated advantages will be better understood from the following description when considered in connection with the accompanying figure. Thefigure is provided for the purpose of illustration and description only, and not as a definiti on of the limits of the claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] A further understanding of the nature and advantages of the embodiments may be realized by reference to the following drawing. In the appended figure, similar components or features may have the same reference label.

[0010] FIG. 1 illustrates a diagram of an RNA therapy and a therapeutic envelope in accordance with the principles of the present disclosure.

[0011] While the embodiments described herein are susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawing and will be described in detail herein. However, the exemplary embodiments described herein are not intended to be limited to the particular forms disclosed. Rather, the instant disclosure covers all modifications, equivalents, and alternatives falling within the scope of the appended claims.DETAILED DESCRIPTION

[0012] This description provides examples, and is not intended to limit the scope, applicability' or configuration of the invention. Rather, the ensuing description w ill provide those skilled in the art with an enabling description for implementing embodiments of the invention. Various changes may be made in the function and arrangement of elements.

[0013] Thus, various embodiments may omit, substitute, or add various procedures or components as appropriate. For instance, it should be appreciated that the methods may be performed in an order different than that described, and that various steps may be added, omitted or combined. Also, aspects and elements described with respect to certain embodiments may be combined in various other embodiments. It should also be appreciated that the following systems, methods, and devices may individually or collectively be components of a larger system, wherein other procedures may take precedence over or otherwise modify their application.

[0014] The detailed description of exemplary embodiments herein makes reference to the accompanying drawing, which shows an exemplary' embodiment by way ofillustration. While this exemplary embodiment is described in sufficient detail to enable those skilled in the art to practice the disclosure, it should be understood that other embodiments may be realized and that logical changes and adaptations in design and construction may be made in accordance with this disclosure and the teachings herein without departing from the spirit and scope of the disclosure. Thus, the detailed description herein is presented for purposes of illustration only and not of limitation.

[0015] As used herein, RNA cognitive therapy encompasses all transcriptional engineering methods designed to enhance cognition or ameliorate mental health conditions such as anxiety or depression, such as the methods described in co-pending U.S. Application Number 17 / 178, 171 , which is incorporated herein by reference in its entirety.

[0016] As used herein, psychedelic therapy includes all forms of psychotherapy administered in combination with psychoactive compounds for the purpose of alleviating mental health conditions.

[0017] As used herein, RAPT represents RNA-Adjunct Psychedelic Therapy; the method outlined in this application.

[0018] The advantages of the methods described herein include proactive priming, integration, openness, reduced negative effect, and lower dosage. Regarding proactive priming, psychedelic interventions combined with RNA transcriptional engineering cognitive therapy protocols can serve to facilitate the proactive priming of positive 'set and setting' resulting in increased treatment efficacy. Regarding integration, RAPT also stands to improve, reinforce, and dramatically prolong the clinical benefits observed after the administration of psychedelics by enhancing and extending post session 'integration and consolidation' of experience, thereby increasing efficacy and reducing relapse rate. Regarding openness, with research-demonstrated direct correlation between the intensity of mystical -type experiences and insights reported after psilocybin sessions and favorable outcomes, pre-psychedelic RAPT treatment stands to increase patients' "openness to experience" rendering an overall amplification of treatment intervention efficacy. These combinatory mechanisms would also provide a specific increased benefit to treatment resistant patients.

[0019] Regarding reduced negative effect, recent findings suggest psilocybin may decrease negative affect and the respective neural correlates, which (without being limited to any one theory) may be a mechanism underlying its transdiagnostic efficacy. Taken together, these findings suggest that RAPT induced reductions of negative affect may together form a powerful and integrative approach extending treatment to a broader spectrum of patients and individuals. Regarding lower dosage, RAPT serves as a powerful tool for anchoring new beliefs and insights resulting from the intervention, rendering applications that may include potential reductions in drug dose in the event that patients show consistent improvements in behavioral measures pre- intervention.

[0020] The following proprietary method uses RNA cognitive therapy in conjunction with psychedelic therapy to improve patient outcomes. As illustrated in Fig. 1 , the RNA compound provides a therapeutic envelope around the psychedelic therapy session, raising the subject's pre- session openness to change and improving post-session integration of gains.STEP 101: PSYCHOLOGICAL ASSESSMENT TO VERIFY CANDIDATE'S SUITABILITY FOR RAPT THERAPY

[0021] RAPT therapy is suitable for adults who do not suffer from alcohol or substance abuse, bipolar disorder, schizophrenia or certain other psychological conditions or disorders. The process begins with a psychological assessment to screen out candidates who do not meet these criteria, for example.

[0022] The assessment also ensures the candidate is not currently taking any drugs, medications or substances that could interfere with the normal, natural functioning of their brain; for example, alcohol, caffeine, nicotine, cannabis, nootropics, ginseng or other similar substances or herbal preparations.

[0023] Candidates who satisfactorily meet the psychological assessment criteria are accepted as subjects for RAPT therapy.STEP 102: PATIENT EDUCATION

[0024] The Psychedelic pre-session patient curriculum is supplemented with education which explains the RNA therapy and sets positive expectations for optimumresults. The RNA therapy is a tangible physical modification in the patient's neurology. The education uses this physical modification to anchor the patient's new positive beliefs about their ability' to change and improve.STEP 103: ADMINISTER RNA THERAPY

[0025] RNA therapies are administered in the clinic 7 weeks prior to the psychedelic therapy session according to protocols disclosed in co-pending U.S. Application Number 17 / 178,171, which is incorporated herein by reference, and copending U.S. Application Number 63 / 283,150, which is incorporated herein by reference, or other methods which may' be devised by those skilled in the art.STEP 104: CONDUCT PSYCHEDELIC THERAPY

[0026] The psychedelic therapy session is conducted per standard protocols. The RNA therapy is expected to raise patient amenability to change and concomitantly session process depth.STEP 105: POST-SESSION INTEGRATION

[0027] The RNA cognitive therapy's antidepressant and anti-anxiety effects act as a temporary' buffer between the patient's new outlook and their existing life and environment; reducing cognitive dissonance, improving integration of session gains, and facilitating the development of new behaviors.

[0028] The foregoing description, for purpose of explanation, has been described with reference to specific embodiments. However, the illustrative discussions above are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the present systems and methods and their practical applications, to thereby enable others skilled in the art to best utilize the present systems and methods and various embodiments with various modifications as may be suited to the particular use contemplated.

[0029] Unless otherwise noted, the terms "a" or "an," as used in the specification and claims, are to be construed as meaning "at least one of' In addition, for ease of use. the words "including" and "having." as used in the specification and claims, areinterchangeable with and have the same meaning as the word "comprising." In addition, the term "based on" as used in the specification and the claims is to be construed as meaning "based at least upon."

Claims

CLAIMSWHAT IS CLAIMED IS:

1. A method of treating a patient with a mental health condition, the method comprising: conducting a psychological assessment to verify the patient's suitability forRNA- Adjunct Psychedelic Therapy (RAPT); educating the patient about RAPT: administering RNA therapy to the patient: administering psychedelic therapy to the patient: and administering post-session integration,2. The method of claim 1, wherein conducting a psychological assessment to verify the patient's suitability for RAPT comprises determining the patient does not suffer from alcohol or substance abuse, bipolar disorder, or schizophrenia.

3. The method of claim 1, wherein conducting a psychological assessment to verify the patient’s suitability for RAPT comprises determining is not currently taking any drugs, medications or substances that could interfere with the normal, natural functioning of the patient’s brain.

4. The method of claim 1, wherein administering RNA therapy to the patient comprises administering RNA therapy to the patient 7 weeks prior to the psychedelic therapy session.

5. The method of claim 1, wherein the psychedelic therapy session is conducted per standard protocols.

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