Monthly Archives: June 2022

RIYADH: Psychedelic researcher Stanislov Grof once wrote that psychedelics, used responsibly and with proper caution, would be for psychiatry what the microscope is for biology and medicine or the telescope is for astronomy.

To many, this may sound like an outlandish claim, but now more than ever, it is proving to be true and may very well become a frontier in practicing medicine.

Saudi Arabia was enduring a mental health epidemic and the psychological strains of the pandemic exacerbated that. People are finding themselves desperate for ways to cope. One of the most recent psychotherapy methods in the region, albeit stigmatized, is psychedelic-assisted psychotherapy. A recent study published by Neuropsychopharmacology showed that the substances were proven to achieve positive long-term mental health effects and their efficiency, safety and tolerability in treating major depression, post-traumatic stress disorder, obsessive-compulsive disorder and certain addictions.

I get more people contacting me asking me how they can receive this treatment, and its really heartbreaking to tell them, Im sorry, but youre gonna have to wait. Its not available yet.

Haya Al-Hejailan, Saudi well-being practitioner and psychedelic integration specialist

It is also associated with enhancing creativity and problem-solving, according to an article published by the Journal of Psychoactive Drugs in 2019.

While the stigma around mind-altering substances, both in the region and globally, is unavoidable, researchers and scientists argue that if these drugs are regulated and used purely for medicinal reasons, what is the harm?

The term psychedelics, a class of hallucinogens, comes from the Greek words psyche, meaning the mind, and delia, meaning manifesting. The psychoactive substances are meant to alter the mind and create an alternative cognitive perception.

Psychedelics are classified into classical, which includes lysergic acid diethylamide (LSD), psilocybin (commonly known as magic mushrooms), mescaline and others, and non-classical, such as methylenedioxymethamphetamine (MDMA or ecstasy) and ketamine.

(Theyre) really great tools for us being able to understand the brain and the study of consciousness better, Saudi well-being practitioner and psychedelic integration specialist Haya Al-Hejailan told Arab News. Her work centers on psychedelic research and the treatment of borderline personality disorder.

This point may seem counterintuitive: How can addiction be treated with a substance that may cause another addiction? But psychedelics are, in fact, anti-addictive in nature.

They have anti-addictive properties, meaning they dont constitute physiological addiction, but one can become psychologically addicted to anything, said Al-Hejailan, refererring to non-substance addictions such as coffee or mobile devices.

However, the use of psychedelics can pose certain dangers, making it crucial to undergo treatment strictly under professional medical supervision, which can only be accessible through clinics. Psychedelic therapists are trained to create a controlled environment for patients undergoing psychedelic therapy, with sessions prior to administering the treatment dose to identify any red flags or possible risks that would otherwise create a larger margin of error. Patients who self-dose could potentially be subject to health risks, retraumatization, depersonalization and dissociation.

I get more people contacting me asking me how they can receive this treatment, and its really heartbreaking to tell them, I'm sorry, but youre gonna have to wait. Its not available yet, Al-Hejailan said. But Im optimistic with highlighting the word yet.

An article published by The Lancet showed that most antidepressants are ineffective and can be harmful to adolescents and children.

In an attempt to fulfill that medical need, several research efforts and trials have been unertaken to evaluate alternative routes, such as psychedelic-assisted therapy.

A study published by the National Library of Medicine found that small IV doses of ketamine can have positive, long-lasting antidepressant effects in patients. Although the scientific research regarding psychotherapeutic psychedelic use in the region is insufficient, Saudi Arabia has been easing its way into their use use for other purposes. Last year, the Saudi Journal of Emergency Medicine published a paper describing a successful case of refractory status epilepsy, a life-threatening condition, in a child treated with a single dose of ketamine.

Despite its growing popularity in mainstream media, psychedelic science is one of the cutting-edge neurosciences, yielding insufficient research compared to other sciences. The 1950s saw the first English-language report published on LSD, and research continued into Richard Nixons US presidential term, ending in the 70s. However, research efforts were quickly banned under the justification of the war on drugs as a public enemy declared by the US president. However, it was supported by other factors, such as the lack of funding for psychedelic research and failed medical trials, according to an article published by the Cambridge University Press.

That area of medicine was considered niche until recently. In 2017, MDMA was given breakthrough therapy designation by the Food and Drug Administration, meaning it was granted an expedited review process. In 2018, the FDA granted a group of psychiatrists researching psilocybin-assisted therapy for treatment-resistant depression the same status.

In the same year, Michael Pollans book How to Change Your Mind created a public space for people to think differently about psychedelics and the consciousness expansion of the mind. Ketamine was granted the same status a year later. Arguably, that is when psychedelics hit the mainstream, although its resurgence into clinical research and trials resumed in the 1990s.

(Before that) I was met with a lot of skepticism. People literally thought I was talking about something thats crazy, Al-Hejailan said in reference to discussing psychedelic-assisted psychotherapy before 2018.

Theres a lot of interest, enthusiasm and curiosity that Im met with now when I talk about my work.

With a masters in applied positive psychology and coaching psychology from the University of East London, Al-Hejailans work also includes positive psychology integration and psychedelic education, providing training in psychedelic therapy and ketamine-assisted psychotherapy. She also co-directed and co-produced a documentary titled Psychedelic Renaissance, centered on the reemergence of the psychedelic movement globally and its cultural significance.

Al-Hejailan said that raising awareness about psychedelic studies was the first step in creating a regional environment that allows for alternative psychotherapy methods.

I think we need to, in general, focus more of our energy and attention on psychoeducation, educating the public about mental health and well-being. The more we do that, the more people are likely to continue becoming accepting and interested, she said.

Future steps to normalize the use of psychoactive drugs include active training for clinicians and therapists on their uses and benefits and eventually establishing specialized clinics and research centers.

My goal is to have presentations specifically on psychotherapy and to meet with therapists, psychologists, psychiatrists and other physicians, and policymakers at some point. To show them whats happening abroad, what the science shows and to discuss how we can replicate this here in a safe way that respects our culture and that respects our specific or unique needs, Al-Hejailan said.

I really want to open a clinic and research center here. Me and my colleagues would very much love to see Saudi pioneer in psychedelic research in the region, and maybe globally.

Excerpt from:

Is there a future for psychedelic treatment in Saudi Arabia? - Arab News

VANCOUVER, British Columbia, June 28, 2022 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (Optimi or the Company), a homegrown, Canadian company producing natural, scalable, and accessible psychedelic and functional mushrooms, as well as synthetic formulations for transformational human experiences, is pleased to announce that it has entered into a supply agreement with SABI Mind, a Calgary-based clinic group providing psychedelic-assisted therapies.

The Company has signed an agreement which will provide SABI Minds trained clinical staff with supplies of GMP psilocybin and 3,4-Methylenedioxymethamphetamine (MDMA), pending the anticipated approval of its previously announced licensing amendment, for use by practitioners in psychedelic-assisted therapeutic protocols with approved patients via Health Canadas Special Access Program, clinical trials, and academic studies.

This agreement is an important step forward for both parties, said Optimi Health CEO Bill Ciprick. SABI Minds initiation of this agreement demonstrates a commitment to safe supply for the development and implementation of therapeutic modalities using psilocybin and MDMA.

Clinical distribution is a major milestone in the growth of Canadas psychedelics sector from the standpoints both of business operations, and as a medical option for those in need.

Theres growing evidence that MDMA and psilocybin assisted therapies can help treat PTSD, depression and other chronic mental health conditions, said Philippe Lucas PhD, SABI Mind President. Were very pleased to be working with Optimi to ensure a safe, consistent supply of psilocybin and MDMA to SABI patients qualifying under Health Canadas Special Access Program.

As we continue to establish the logistical channels of our new industry, Optimi is extremely gratified to receive requests such as this, added Ciprick. The knowledge that the substances we produce, natural or synthetic, will be used by patients in a safe environment to further psychedelic science is a vindication of the principles on which this company was established.

Optimi Health recently requested an amendment to its Controlled Substance Dealers Licence from Health Canada which would enable it to utilize its state-of-the-art analytical laboratory for the production of synthetic MDMA, among other substances.

SABI Mind currently operates a best-in-class clinic in the Sunalta area of Calgary, with expansions planned into Edmonton, Alberta and Victoria, British Columbia.

Authorized parties interested in purchasing Optimi psilocybin and functional mushroom products, MDMA, or other synthetic psychedelics are invited to contact sales@optimihealth.ca where a member of the sales team will respond within 24 hours.

ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)

Optimi Health Corp. is a homegrown, Canadian success story producing and supplying natural, EU-GMP grade psilocybin and functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable, natural mushroom formulations for transformational human experiences, the Companys goal is to be the number one trusted, compassionate supplier of safe, natural EU-GMP psilocybin throughout the world. With a vertically integrated approach, Optimi is engaged in the cultivation, extracting, processing and distribution of high quality functional and psychedelic mushroom products at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.

About SABI Mind

Located in Calgary, SABI Mind supports the careful and necessary mending of mental health and chronic pain through psychedelic-assisted therapies. Founded by a group of Calgary-based entrepreneurs brought face-to-face with the challenges of those suffering from mental health conditions, SABI Mind empowers those discouraged by the conventional medical methods with a patient-centered treatment model supported by experienced psychiatrists, anesthesiologists, therapists, client experience specialists, and other clinic staff specially trained in ketamine-assisted psychotherapy and other psychedelic therapies.

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:

Investor Relations Michael Kydd Email: investors@optimihealth.ca Phone: +1 (902) 880 6121 Web: https://optimihealth.ca

FORWARDLOOKING STATEMENTS

This news release contains forwardlooking statements and forwardlooking information within the meaning of Canadian securities legislation (collectively, forwardlooking statements) that relate to Optimis current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as will likely result, are expected to, expects, will continue, is anticipated, anticipates, believes, estimated, intends, plans, forecast, projection, strategy, objective, and outlook) are not historical facts and may be forwardlooking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forwardlooking statements. No assurance can be given that these expectations will prove to be correct and such forwardlooking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward looking statements pertaining to activities proposed to be conducted under the Companys dealers license and associated business related to Psilocybin and Psilocin and Optimis plans, focus and objectives.

Forwardlooking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimis control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forwardlooking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID19 pandemic and other factors set forth under ForwardLooking Statements and Risk Factors in the Companys Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimis profile at http://www.sedar.com. Optimi undertakes no obligation to update or revise any forwardlooking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forwardlooking statement.

Any forwardlooking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/67fd5330-02d3-40bb-af5b-938cb2c94f6d

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/49bf2da6-a0b2-481e-9cf3-eed6879d5af7

Optimi Health Cultivation and Analytical Facilities

Optimi Health Cultivation and Analytical Facilities

Optimi Health Fruiting Room

Optimi Health fruiting room being prepared for second grow.

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Optimi Health Initiates Agreement With SABI Mind For Therapeutic Supplies Of Psilocybin, MDMA - Marketscreener.com

TORONTO, June 24, 2022 /PRNewswire/ - Braxia Scientific Corp. ("Braxia", or the "Company"), (CSE: BRAX) (OTC: BRAXF) (FWB: 4960), a medical research company with clinics providing innovative ketamine treatments for persons with depression and related disorders, is pleased to announce its participation at the H.C. Wainwright Global Investment Conference from June 27 28, 2022 in New York.

Braxia Scientific CEO Dr. Roger McIntyre will deliver two live presentations at the conference beginning with a Keynote address - Introduction to the State of Mental Healthcare to kick off the conference on Monday, June 27 at 8:15 a.m. ET

Dr. McIntyre, will also deliver a second presentation on Monday, June 27 at 4:00 p.m. ET providing an overview of the Braxia's business, including its progress on increasing access to novel ketamine and psychedelic treatments for patients with depression, while also expanding the clinical research infrastructurerequired to execute on the Company's growing pipeline of registered clinical trials alongside third-party sponsors.

Braxia's trials include Canada's first multi-dose psilocybin-assisted therapy trial which commenced in November 2021 and recently reported positive preliminary results.

Dr. McIntyre will also be available to host one-on-one meetings with institutional investors registered with H.C. Wainwright and Co.

About Braxia Scientific Corp.

Braxia Scientific is a medical research company with clinics that provide innovative ketamine treatments for persons with depression and related disorders. Through its medical solutions, Braxia aims to reduce the illness burden of brain-based disorders, such as major depressive disorder among others. Braxia is primarily focused on (i) owning and operating multidisciplinary clinics, providing treatment for mental health disorders, and (ii) research activities related to discovering and commercializing novel drugs and delivery methods. Braxia seeks to develop ketamine and derivatives and other psychedelic products from its IP development platform. Through its wholly owned subsidiary, the Canadian Rapid Treatment Center of Excellence Inc., Braxia currently operates multidisciplinary community-based clinics offering rapid-acting treatments for depression located in Mississauga, Toronto, Ottawa, and Montreal.

ON BEHALF OF THE BOARD"Dr. Roger S. McIntyre"

Dr. Roger S. McIntyreChairman & CEO

The CSE has not reviewed and does not accept responsibility for the accuracy or adequacy of this release.

Forward-looking Information Cautionary Statement

This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations, or beliefs of future performance are "forward-looking statements."

Forward-looking statements include statements about the intended promise of ketamine-based treatments for depression and the potential for ketamine to treat other emerging psychiatric disorders, such as Bipolar Depression. Such forward- looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events, or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the failure of ketamine, psilocybin and other psychedelics to provide the expected health benefits and unanticipated side effects, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licenses and engaging in activities that could be later determined to be illegal under domestic or international laws. Ketamine and psilocybin are currently Schedule I and Schedule III controlled substances, respectively, under the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (the "CDSA") and it is a criminal offence to possess such substances under the CDSA without a prescription or a legal exemption. Health Canada has not approved psilocybin as a drug for any indication, however ketamine is a legally permissible medication for the treatment of certain psychological conditions. It is illegal to possess such substances in Canada without a prescription.

These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company's filings with Canadian securities regulators, including the Amended and Restated Listing Statement dated April 15, 2021, which are available at http://www.sedar.com. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements.

SOURCE Braxia Scientific Corp.

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Braxia Scientific CEO to Deliver Keynote Address at HC Wainwright & Co. 1st Annual Mental Health Conference: Neuropsychiatry, Psychedelics, and...

Of Hawaii's residents, around 8.8% and 8% report a lifetime prevalence of depression or anxiety, respectively [1].A Hawaii personality and health survey showed that 83.1% of participants reported at least one traumatic event occurring in their lifetime [2], higher than the national average of 70.4% [3].Yet around 20% of Hawaii's residents, exceeding the national average of 8.3%, were not able to receive care due to access to care barriers [1].

On April 4, 2019, United States Senator Brian Schatz (D-HI) wrote a letter to the Food and Drug Administration (FDA) and the National Institute of Health (NIH) inquiring about the governments plans to investigate the medicinal value of psychedelics [4].On June 13, 2019, the FDA and NIH responded in a co-authoredmessage acknowledging the therapeutic potential of psychedelics from the results of recent clinical trials and the need for more research [5].On June 28, 2021, the Multidisciplinary Association for Psychedelic Studies (MAPS) responded to the FDA and NIH with clarification regarding clinical trials evidence supporting the safety and efficacy of psychedelics in the treatment of mental health disorders [5].

On January 22, 2021, Hawaii Senator Stanley Chang (District 9) introduced Senate Bill No. 738, which will potentially remove psychedelic mushrooms (psilocybin) from the list of Schedule I controlled substances and establish psychedelic treatment centers as well [6].Promising clinical trials of psychedelics used as medications to treat mental health disorders, such as major depressive disorder, are driving the State of Hawaii to consider the potential medical benefits of psychedelics for Hawaii's residents [4].

Ketamine, a substance producing psychedelic experiences and hallucinations, has been used to treat depression for many years. In 2019, esketamine-a non-psychedelic enantiomer of ketamine-became approved by the FDA as a psychiatric treatment for major depressive disorder [7].Currently, MDMA is estimated to be the next psychedelic to be FDA-approved potentially. Psilocybin, ketamine, and MDMA all have an extensive history of use in recreational settings. However, in controlled clinical settings, each has been adapted for therapeutic purposes as an adjunct in treatment [8].

When paired with therapy, MDMA is the only psychedelic drug proven efficacious for treatment-resistant post-traumatic stress disorder (PTSD). Methylenedioxymethamphetamine-assisted therapy (MDMA-AT)to treat other conditions such as eating disorders and alcohol use disorder continues to be researched. To date, MDMA-AT is found to be potentially beneficial for various problems related to psychological trauma, such as anxiety from a life-threatening illness and social anxiety in autistic adults.

In 1912, pharmaceutical company Merck filed two patent applications that described the chemical synthesis of MDMA and its unique psychoactive properties. Further drug development research halted until 1959 when Wolfgang Fruhstorfer synthesized MDMA for pharmacological testing while researching stimulants [9].In the 1960s, chemist Alexander Shulgin documented his experiments with synthesizing MDMA and numerous other related compounds in Phenethylamines I have known andloved (PIHKAL): A Chemical Love Story [9]. Leo Zeff would later use MDMA as an adjunct to psychotherapy, introducing it to approximately 150 other psychotherapists, ultimately responsible for an estimated 500,000 doses of MDMA administered in therapeutic settings [10]. By the 1980s, many psychotherapists adapted MDMA as part of their practice due to its ability to accelerate the therapeutic process. Although there were no clinical trials nor government approval, MDMA-AT was legally used for couplescounseling, relationship problems, depression, anxiety, substance use disorders, premenstrual syndrome, and autism, among several other psychiatric disorders [10].

As the war on drugs raged on with racially disproportionate mass incarceration amid crack cocaine-dominated headlines, MDMA raised the attention of the Drug Enforcement Agency (DEA). During a debate on the Phil Donahue show on banning MDMA, researchers shared pre-published reports stating that the drug caused brain damage in rats and soit could do the same in humans. However, the information was misleading since it did not note the significantly large and frequent intravenous doses given to the rats [11].A study [12] published in Science showing MDMA was neurotoxic in primateswas later redacted due to the lab being found to have been injecting methamphetamine instead of MDMA [13]. Other news sources furthered the claim that MDMA caused brain damage, but they confused it with the synthetic heroin designer drug 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP), which caused acute onset Parkinsonism. Methylenedioxymethamphetamine entered a burgeoning recreational drug counterculture before being banned as a Schedule I substance in 1985 as another salvo in the War on Drugs [10].

The DEAsdrug denominations range from Schedule I to V, with Schedule I drugs having the highest risk of abuseand Schedule V drugs having the lowest potential for abuse [14]. The DEA designated MDMA as Schedule I, declaring that it had no currently acceptable medical use [14] despite the Schedule III recommendation from the DEA judge overseeing the proceedings [15]. Due to the extensive hurdles involved with DEA approval and public funding, clinical research was stunted. Medical researchers still believe in MDMA's therapeutic potential, particularly among people with PTSD, depression, and other psychiatric issues. In 1986, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) was founded to secure private funding for clinical trials despite these barriers [10].Since then, MAPS has raised over $130 million for scientific research of psychedelics and cannabis for therapeutic purposes. In 2004, the DEA and the FDA approved MAPS to research MDMA's efficacy as an adjunct to psychotherapy. The first clinical trial of MDMA-AT was conducted in Spain but ended early due to political pressure[16]. The first completed study was conducted in the United States and was published in 2011 [17].

The FDA granted breakthrough therapy status to MDMA-AT in 2017 based on evidence from the phase-II clinical trials [18]. Multidisciplinary Association for Psychedelic Studies reported a series of six phase-II clinical trials looking at MDMA-AT for PTSD. Participants met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-4-TR) criteria for a diagnosis of PTSD and were treatment-resistant to at least three months of antidepressant treatment and six months of psychotherapy. Participants were provided several preparatory pre-MDMA sessions, two or three eight-hour MDMA-assisted psychotherapy sessions each one month apart, and several follow-up non-drug psychotherapy sessions described as integration sessions. After two MDMA-AT sessions, 54% of participants in the MDMA group did not meet the criteria for PTSD compared to 23% of the placebo group [19]. After three MDMA-AT sessions, 67% of participants no longer met the criteria for PTSD [20]. These effects were durable at the one-year follow-up, with 67% not meeting PTSD criteria [21]. At nearly four years, 74% no longer met PTSD criteria. Participants who reported suicidal ideation decreased from approximately 60% to 24% [21].

In 2021, MAPS and the FDA agreed on the design for phase-III trials. The phase -III trials were the first multi-site randomized, double-blinded, placebo-controlled trial, testing 90 participants with severe PTSD [20]. Participants received three sessions with 80 mg to 120 mg of MDMA and either an additional half-dose after 1.5-2 hours or, a placebo combined with three preparatory and three integrative therapy sessions after each medication session. Drug safety included assessing the participant's heart rate, blood pressure, and body temperature while being cognizant of any signs of adverse events and thoughts such as suicide. Common side effects included decreased appetite, muscle tightness, and hyperhidrosis, but they were transient and mild to moderate in severity [20].

Phase-III data indicates that MDMA-AT is highly effective, safe, and well-tolerated in individuals who have a treatment-resistant PTSD diagnosis, and even in those with comorbidities.Post-traumatic stress disorder treatments are desperately needed, and MDMA-AT represents a potential breakthrough treatment that merits expedited clinical development [20].

A second phase-III clinical trial at MDMA-AT-approved clinics is currently enrolling participants and is expected to be published in 2022. If the FDA approves MDMA-AT, policies will be required for determining physician qualifications to prescribe and administer MDMA, MDMA-AT site qualifications, and how it will be produced and stored.

Methylenedioxymethamphetamine is a psychoactive drug that increases the endogenous release of the neurotransmitters serotonin, norepinephrine, and dopamine. It also leads to the release of neurohormones such as oxytocin, which is thought to be a primary mediator of its effects. Subjective effects include stimulating social connectedness, empathy, euphoria, and feelings of communion. Oxytocin has emerged as an essential component in elucidating the reopening of critical periods for social reward learning and mediating interpersonal bonding [22]. The use of MDMA alongside psychotherapy allows participants to revisit past distressful memories in a state of emotional security and empathic self-reflection.

Individuals with PTSD have an amplified and uncontrolled response from the amygdala to trauma-specific cues. Increasing serotonin helps regulate mood, while oxytocin increases trust and emotional awareness by reducing the amygdalas response [23]. The effects are decreased hypervigilance and anxiety and improved states of consciousness [24]. Moreover, MDMA activates serotonin (5-HT2A) receptors, which increases sedation and relaxation that may be conducive to addressing trauma-induced hypervigilance and promoting memory consolidation [25].

Oxytocin, commonly referred to as the love hormone, has sparked the interest of scientists for its potential to regulate anxiety and promote social bonding. However, translational pharmaceutical research has proven difficult, as oxytocin does not readily cross the blood-brain barrier. Methylenedioxymethamphetamine is an indirect inducer of oxytocin release and thus may explain MDMA's effects on PTSD. Because of this unique property, Nardou et al. [22]decided to use MDMA to investigate oxytocin's role in critical periods. Critical periods are developmental periods during which the nervous system is expressly sensitive to specific environmental stimuli required for proper organization and learning [22]. Closure of critical periods limits the ability of the brain to adapteven when optimal conditions are restored. This could explain the high treatment non-response rates seen in PTSD. A single dose of MDMA was enough for adult mice to reopen the critical period for social reward learning via oxytocin-mediated plasticity in the nucleus accumbens. In contrast, isolated adult mice administered MDMA did not exhibit the reopening of their critical period. These data suggest that it is the combination of the MDMA-mediated effects of oxytocin along with a therapeutic environment that is the key to the therapeutic efficacy of MDMA-AT [22].

The treatment approach of MDMA-AT is ultimately an interaction between the drug's effects, the therapeutic setting, and the mindset of the participant and therapists. Methylenedioxymethamphetamine catalyzes therapeutic processing, promoting participants emotional engagement with decreased anxiety or other painful emotions at the time of revisiting traumatic experiences.Frequently, participants can experience and express fear, anger, grief, empathy, love, and gratitude as part of the therapeutic process in a manner with less judgment and greater acceptance. Also, MDMA can facilitate a heightened state of empathic therapeutic rapport that promotes the therapeutic process and develops a corrective experience of secure attachment [8].

The primary focus of MDMA-AT is to diminish symptoms related to unresolved trauma and improve the overall wellbeing and quality of life of the participant. Processing traumatic experiences is an essential part of MDMA-AT, though sessions may explore other psychological, interpersonal, and spiritual aspects of life. Empathy and self-exploration facilitate the healing of participants since it allows each participant's experience to unfold spontaneously. However, if a patient encounters emotional or somatic blocks that stymie this process, the therapist can provide more active guidance to help them work through past events and arrive at a new emotional resolution. Therapists help explore and validate new perspectives about other life experiences and authentically join participants in embracing joyful moments [26].

The MDMA-AT consists of a preparatory stage with screening and introductory sessions, followed by one to three experimental sessions interspersed with integrative sessions and follow-up evaluations. The screening and preparatory stage is when the therapist gathers the participants history and builds therapeutic rapport [27]. During the experimental stage, an 80 mg to 120 mg capsule of MDMA is orally administered. The participant is monitored through medical devices, listens to a predetermined setlist of emotionally provocative music, engages in mindful use of touch as appropriate, and engages in conversation with the therapist. Peak effects typically occur 70 to 90 minutes after drug administration and persist for one to three hours [28]. After two hours, a supplemental half dose of 40 mg to 60 mg is optionally provided. Therapists work with the participant for six to eight hours or until the drug's psychedelic effects have worn off. As the MDMA subsides, therapists may talk with the participant more extensively about what they experienced during the session [27].

During the MDMA experience, participants acquire heightened clarity about the traumatic event and can view it as something of the past. Participants have disclosed that through MDMA-AT, processing painful emotions successfully changed their relationship with their emotions and trauma narrative. Methylenedioxymethamphetamine grants access to meaningful spiritual experiences and other transpersonal experiences. Although unexplainable, many participants feel a sense of healing on a non-verbal level, which is deemed essential to the therapeutic process [29].

The terms 'ecstasy' and 'MDMA' are commonly confused. Substances classified as ecstasy may contain MDMA, but frequently contain other unknown and/or dangerous components. In controlled doses, pure MDMA has been proven safe for human consumption. Furthermore, critics highlight studies that illustrate the dangers of MDMA as a recreational drug, which is misleading since there are sufficient differences between ecstasy and MDMA that would confound a generalized comparison between the two [30].

While it is well established in rat studies that injected doses of MDMA are neurotoxic, these doses are well above those provided for therapy. Likewise, human trial participants have failed to show evidence of neurotoxic effects of any minuscule amount. Additionally, while some studies have shown an inconsistent pattern of mild memory deficits, these have been blended by substantial polysubstance use among MDMA users [11]. In a study of 87 deaths where MDMA was present, only six involved the drug alone, and the two most common causes of death were heatstroke and anti-diuretic hormone (ADH)-mediated hyponatremia, both likely exacerbated by recreational settings with increased physical exertion [31]. Of the approximately 200 participants in recent clinical trials of MDMA-AT for PTSD, none have suffered serious adverse events related to hyponatremia or hypothermia, which are the most common causes of morbidity and mortality in recreational settings [20].

Yet, MDMA is to some degree unpredictable, producing diverse responses in people. Methylenedioxymethamphetamine causes neurotransmitter activation across the main neural pathways, including serotonin and dopamine, and norepinephrine, resulting in substantial fluctuations in mood and emotions depending on the memories that emerge for the participant. When the effects of MDMA taper, there is a neurochemical depletion stage due to serotonin exhaustion. Neurochemical depletion can invoke temporary anhedonia, lethargy, anger, depression, irritability, anxiety, increase in daily stress, altered pain thresholds, changes in sleep, and nightmares, especially in female participants [32]. However, these pitfalls are duly addressed in MDMA-AT by having the participant stay overnight at the site of administration with a trained same-sex overnight attendant, and the first integration session is scheduled for the morning after with the second integration session often within a week after the MDMA session to allow for closer monitoring and follow-up care.

Methylenedioxymethamphetamine has a risk of dependence and harm compared to other recreational substances [33,34] and is often described as a "self-limiting" drug due to its usage patterns often being relatively infrequent [35]. Because MDMA is a self-limiting drug, dependency rates may be as low as 1% of users [24].

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Methylenedioxymethamphetamine (MDMA)-Assisted Therapy in Hawaii: A Brief Review - Cureus