Reschedulepsilocybin.org
A fair brighter future for all Promoting global access to psilocybin-assisted therapies for those suffering from mental illness and addiction.
OUR MISSION
Reschedulepsilocybin.org
Driven by concerns regarding equity of access and a belief that the benefits of psilocybin-assisted therapies represent a global public good, ITPRI was established to promote and secure a rescheduling of psilocybin under the 1971 Convention on Psychotropic Substances.
More About ITPRI’s Mission
The leading cause of disability adjusted life years lost
Hundreds of millions worldwide suffer daily from mental illness and addiction. Despite the massive scope of this problem, few effective treatments are available for patients.
GLOBAL BURDEN OF MENTAL ILLNESS AND ADDICTION
PSILOCYBIN
3-[2-(Dimethylamino)ethyl]indol-4-yl hydrogen phosphate
A potential game-changer for patients
Psilocybin-assisted therapy offers an unprecedent opportunity to provide equitable, affordable and high-quality mental health treatment to those who need it, no matter where they live.
Psilocybin-assisted therapy
Removing psilocybin from schedule I
Rescheduling of psilocybin under the 1971 Convention on Psychotropic Substances offers a game-changing opportunity to further advance research and accelerate the approval of treatments for patients. Scheduling Procedures Under The 1971 Convention
Reschedulepsilocybin.org
To ensure equity of access to psilocybin as a global public good, ITPRI is engaging, educating and mobilizing officials and other stakeholders within the ecosystem of UN institutions, member state permanent missions and NGOs that will be critical to achieving a review and change in scheduling. We invite you to join us. SUPPORT ITPRI TO HELP CHANGE LIVES
Partners and supporters
Equity of Access
ITPRI International Therapeutic Psilocybin Rescheduling Initiative
1971 Convention on Psychoactive Substances
ITPRI International Therapeutic Psilocybin Rescheduling Initiative

C12H17N2O4P

C12H17N2O4P

1971 Convention on Psychoactive Substances
WHO Expert Committiee
on Drug Dependence

More about ITPRI's mission

Psilocybin is one of several psychedelic compounds that have shown remarkable promise for the treatment of a range of mental health conditions, including treatment resistant depression, post-traumatic stress disorder, anxiety, anorexia, end-life-trauma and substance abuse disorder. Designated a break-through therapy by the U.S. Food and Drug Administration, psilocybin is currently being studied in phase three clinical trials to establish its safety and efficacy for therapeutic use. However, the current status of psilocybin as a Schedule I drug under the 1971 UN Convention on Psychotropic Drugs adds significantly to the costs, complexity and duration of research and will ultimately delay the availability of treatments for patients in most countries around the world.

In most jurisdictions, the legal control of psilocybin and other psychedelics results from the 1971 Convention on Psychotropic Substances. The 1971 Convention contains four Schedules of controlled substances, ranging from Schedule I, the most restrictive, to Schedule IV, the least restrictive. Schedule I includes psychedelics drugs such as psilocybin, MDMA, mescaline and LSD, whereas Schedules II through IV are mainly composed of licitly manufactured pharmaceuticals. The evidentiary basis for including various psychedelics compounds in Schedule I are unclear but appear to have been based largely on political considerations and a mistaken presumption that these drugs offered no medical benefit and posed a high risk of abuse and dependence.

These scheduling decisions and implementing legislation such as the U.S. Psychotropic Substances Act, the UK Misuse of Drugs Act and the Canadian Controlled Drugs and Substances Act make conducting research on these drugs, either basic or clinical, both costly and difficult. State Parties to the 1971 Convention, of which there are 175, are obligated to implement the Convention’s Article 7 Special provisions regarding substances in Schedule I. These provisions provide for a level of regulatory control and supervision that is drastically more onerous than for those drugs under Schedules II through IV. As a result, researchers wishing to study psilocybin face numerous regulatory hurdles which create significant burdens in terms of expense and the length of time required to carry out research and secure approvals for treatments.

While a small number of regulatory bodies, including the U.S. FDA and Canadian Department of Health have taken positive steps in recognizing the therapeutic potential of psilocybin, these are unlikely to have any impact on regulatory regimes that hinder research and the availability of therapies around the rest of the world.

Rescheduling procedures under the 1971 Convention offer a potentially game-changing opportunity to advance further research and accelerate the approval of treatments for patients by providing signatory governments with the legal flexibility and evidentiary basis adopt changes in regulatory controls for scientific and medical use.





Global burden of mental illness and addiction

Around the world, hundreds of millions of individuals struggle daily mental illness and substance use disorder, a situation that have been massively exacerbated as a result of the COVID-19 pandemic. According to the World Health Organization (WHO), mental health conditions are the leading cause of disability-adjusted life years lost and account for 37% of healthy life years lost from non-communicable diseases.

Despite the massive scope of this problem few effective treatments are available for patients. According to the WHO’s Office for Disease Prevention and Promotion, the public health need for new medicinal treatments to support those with mental health problems is vast. This is particularly the case in many low-and-middle-income countries where governments struggle to provide even basic medical services.

Current standard of care treatments such as SRRIs often prove ineffective for most patients, while for others the benefits of these drugs, which may have to be taken daily for months and even years, are often accompanied by significant adverse side-effects. With few medications under development there exists a desperate need for new and alternative treatments.

Low efficacy

75% of patients with treatment resistant depression are inadequately treated

SRRIs can take up to 3 months or longer to take full effect

Only half of patients respond within the first two months treatment and over one-third become treatment resistant

Adverse side-effects

Over half of patients on SRRIs experience sexual dysfunction

Depending on the medication taken, patients on average gain between 7-11kg over the course of a year

Other common side effect include insomnia, blurred vision, headaches, diarrhoea, nausea and feeling agitated, shaky or anxious








Scheduling procedures under the 1971 UN Convention on Psychotropic Drugs

Scheduling decisions in terms of adding substances or changing the scope of control are governed by scheduling procedures under the 1971 Convention on Psychotropic Drugs and fall under the purview of the UN Commission on Narcotic Drugs (CND). Formal scheduling reviews may be initiated either by the World Health Organization (WHO) or by notification by any State Party to the treaty. As part of this process, the WHO’s Expert Committee on Drug Dependence (ECDD), which is composed of independent experts in the field of drugs and medicines, is tasked with making scheduling recommendations based a medical and scientific review of therapeutic potential and abuse liability of the compound in question.

Guided by the provisions of the 1971 Convention, its preambles and the WHO’s Guidance for the WHO Review of Psychoactive Substances for International Control, the ECDD has adopted the following criteria for its scheduling recommendations:[1]

Schedule I

Substances whose
liability to abuse constitutes an especially serious risk to public health and which have very limited, if any, therapeutic
usefulness

Schedule II

Substances whose
liability to abuse constitutes a substantial risk to
public health and
which have little to
moderate therapeutic
usefulness

Schedule III

Substances whose
liability to abuse
constitutes a
substantial risk
to
public health and
which have moderate to great therapeutic
usefulness

Schedule IV

Substances whose
liability to abuse
constitutes a smaller
but still significant
risk
to public health
and which have a
therapeutic
usefulness from little
to great



According to guidance adopted by the WHO Executive Board in 2010, recommendations for inclusion in Schedule I should be made only when the above criteria are fully met with respect to both therapeutic usefulness and the risk to public health.[2] Given today’s scientific understanding of psilocybin’s high potential therapeutic value and low risk of abuse liability profile a change to its current status as a Schedule I drug is long overdue.

Encouragingly, recent precedent exists for the review and rescheduling of drugs under the UN drug treaties. On December 4, 2020, the CND voted to accept a WHO recommendation to remove cannabis and cannabis resin from Schedule IV (the most restrictive) of the 1961 Single Convention on Narcotic Drugs. The WHO’s recommendation was based on an ECDD review which stated in part that:

“The evidence presented to the Committee did not indicate that cannabis plant and cannabis resin were particularly liable to produce ill-effects similar to the effects of the other substances in Schedule IV of the 1961 Single Convention on Narcotic Drugs. In addition, preparations of cannabis have shown therapeutic potential  for treatment of pain and other medical conditions such as epilepsy and spasticity associated with multiple sclerosis. In line with the above, cannabis and cannabis resin should be scheduled at a level of control that will prevent harm caused by cannabis use and at the same time will not act as a barrier to access and to research and development of cannabis-related preparations for medical use  [emphasis added].” [3]

As part of our efforts to ensure equity of access to psilocybin-assisted therapy as a global public good, ITPRI is engaging, educating and mobilizing a broad range of officials and other stakeholders operating within the Geneva based ecosystem of Member State Permanent Mission, UN Institutions and NGOs that will be critical to achieving a review and change in scheduling. We invite you to join us.

[1] WHO Expert Committee on Drug Dependence. Seventeenth report. Geneva, World Health Organization, 1970 (WHO Technical Report Series, No. 437).

http://apps.who.int/iris/bitstream/handle/10665/40766/WHO_TRS_437.pdf?sequence=1

[2] Guidance on the WHO review of psychoactive substances for international control, WHO 2010.

https://www.who.int/medicines/areas/quality_safety/GLS_WHORev_PsychoactSubst_IntC_2010.pdf

[3] Annex 1- Extract from the Report of the 41st Expert Committee on Drug Dependence: Cannabis and cannabis-related substances.

https://www.who.int/medicines/access/controlled-substances/Annex_1_41_ECDD_recommendations_cannabis_22Jan19.pdf?ua=1











Psilocybin-assisted therapy



What is psilocybin and how does it work?



Psilocybin, a classical psychedelic, is a chemical produced by more than 100 species of mushrooms of various potency worldwide. Used by different cultures throughout history in religious and other ceremonies, it was first isolated by Swiss chemist Albert Hofmann in 1957 and synthesized the following year.

With similar properties to lysergic acid diethylamide (LSD) and mescaline but a somewhat different chemical structure, psilocybin works by stimulating some types of 5-hydroxytryptamine receptors (serotonin receptors), including in thalamus and cerebral cortex, the parts of the brain responsible for sensory input, mood, cognition and perception. Resulting in often intense mood and perceptual changes in space and time, including sensory alterations commonly referred to as hallucinations, psilocybin can occasion mystical type experiences associated with lasting and positive changes in mood, outlook and behaviour.

Following ingestion, psilocybin is converted by the liver into psilocyn. The hallucinogenic effects of psilocybin usually occur within 30 minutes to an hour of ingestion and typically last between 4 and 6 hours. As with other psychedelics compounds, the effects of psilocybin are likely to be impacted by the quantity consumed, past experiences, the environment in which it is taken and expectations as to the nature of the experience.

While psilocybin may occasion unpleasant or distressing effects, particularly if taken in high doses in uncontrolled settings, these experiences are shown to be relatively rare. Generally experienced by health adults without significant and lasting adverse effects, psilocybin should, however, be avoided by certain individuals, including those with a family history of or disposition to psychotic disorders as well as those with untreated hypertension or other cardiovascular issues.

Psilocybin research


First studied in the 1950s and 1960s, psilocybin and other psychedelic compounds showed early therapeutic promise but changes in regulatory controls, including those resulting from the 1971 Convention on Psychotropic Drugs, brought research efforts to a halt. Following a decades long hiatus, research was allowed to resume in the early 2000s under strict regulatory controls. Since then, research efforts have accelerated with leading academics institutions such John’s Hopkins, Imperial College London, University of Zurich, NYU and others conducting multiple early stage clinical studies.

Therapeutic potential


Research conducted to date has shown potentially game-changing promise for the treatment of a range of mental health conditions, including major depressive disorder, treatment resistant depression, anxiety disorder, post-traumatic stress disorder, anorexia, substance abuse and cancer-related and other end-of life psychological distress.

A 2016 study conducted by Robin Carhart-Harris and colleagues at Imperial College London found that two psilocybin therapy sessions coupled with pre and post psychological support appeared to “markedly reduce” depressive symptoms in twelve patients suffering from unipolar treatment resistant depression.

In John Hopkins study published in JAMA Psychiatry in 2020, a group of 24 patients suffering from major depression was given two doses of psilocybin and psychotherapy support. Researchers reported “rapid and large reductions in depressive symptoms, with most participants showing improvement and half of study participants achieving remission through the four-week follow-up.” According to researcher Alan Davis, “The magnitude of the effect we saw was about four times larger than what clinical trials have shown for traditional antidepressants on the market.” According to the study, the result suggest that psilocybin may be effective in a much wider population of patients who suffer from major depression than previously believed.

Designated a break-through therapy by the U.S. Food and Drug Administration, psilocybin is currently being studied in phase three clinical trials to establish its safety and efficacy for therapeutic use with patients suffering from treatment resistant depression.

Despite the promising results of research to date, more data from large scale clinical trials in needed to establish safety and efficacy and secure regulatory approvals for a range of potential treatments. Without a rescheduling of psilocybin under the 1971 Convention and within domestic regulatory regimes, this process will remain unnecessarily complex, costly and will ultimately delay the availability of treatments for patients.

*The information on this site should not be used to make decisions about medical treatments. Please conduct your own research and due diligence before making any major health changes.












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About

The International Therapeutic Psilocybin Rescheduling Initiative (ITPRI) was established in 2021 as a civil society, not-for-profit association under Articles 60 et seq. of the Swiss Civil Code.

ITPRI’s mission is to promote and secure a rescheduling of psilocybin under the 1971 UN Convention on Psychotropic Substances in order to accelerate research and foster the availability of psilocybin-assisted therapies for those suffering from mental illness and addiction.

Rescheduling procedures under the 1971 Convention offer a potentially game-changing opportunity to advance further research and accelerate the approval of treatments for patients by providing signatory governments with the legal flexibility to adopt changes to domestic regulatory controls that currently limit psilocybin’s scientific and medical use.

Driven by concerns regarding equity of access and a belief that the benefits of psilocybin-assisted therapies represent a global public good, ITPRI was founded to ensure that patients everywhere can gain access to these potentially life-changing therapeutics.

Please note that the content described in this website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please conduct your own research and due diligence and speak with a medical professional before making any major health changes.



Board of Directors

Advisory Board








12 . 3 , 2021

PRESS RELEASES

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12 . 3 , 2021

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PRIVACY POLICY

The protection of your personal data is of vital importance to the International Therapeutic Psilocybin Rescheduling Initiative. Below, you will all the necessary information regarding our Privacy Policy in relation to the personal data we collect and how we use it, including:

• Who is responsible for the collection and processing of your data (data controllers).
• The purposes for which we collect the data.
• The approval process for its processing.
• The length of time for which date is stored.
• The third parties that your data may be share with.
• Your rights in relation to the data we collect.


1. DATA CONTROLLERS

International Therapeutic Psilocybin Rescheduling Initiative (ITPRI)
Frohbergstrasse 36B
8832 Wollerau
Canton Schwyz
Switzerland
info@reschedulepsilocybin.org
+41 (79) 434 25 78
The operational data protection officer of the International Therapeutic Psilocybin Rescheduling Initiative is reachable under the aforementioned address, email and phone number.

2. PERSONAL DATA

Personal data refers to any information or data that could identify a person directly or indirectly. Personal data includes but is not limited to information such as email addresses, postcodes, contact telephone numbers, username(s), credit and debit card number or other data used to make contributions to support our activities. It may also include unique numerical identifiers such as your computer’s IP address and information obtained through the use of cookies.
This privacy policy covers all the personal data collected and used by ITPRI.
The user (you) hereby guarantees that the personal data provided is true and accurate and undertakes to notify ITPRI of any change or modification to the data provided. Any loss or damage caused by ITPRI’s website, the party or parties responsible for data processing or any third party due to the communication of erroneous, inaccurate or incomplete data in the registry forms will be exclusive responsibility of the user.
We may collect or receive your data through our website or forms, amongst other means. In some cases, you provide us will your personal data directly (for example, when you subscribe to our mailing list or when you contact us) and in other cases we collect the data ourselves (for example, using cookies to understand how visitors use our website).
• PURPOSES, APPROVAL AND CONSERVATION of the data to be processed, sent through:

CONTACT FORM:

– Purpose: To provide you with a medium to contact us and for us to answer your requests for information, as well as to send you notices and information on our products, services and activities, including by computerised means, including but not limited to email, SMS and WhatsApp, if the privacy policy acceptance checkbox is checked.

– Legitimate interests: Your consent upon requesting information through our contact form and or upon checking the checkbox for acceptance of the newsletter subscription.

– Conservation: Once your request is resolved through our form or answered by email, if a new treatment was not generated, and in the case of having accepted the receipt of marketing notices, until you request to be unsubscribed from these.


NEWSLETTER SUBSCRIPTION:

– Purpose: The sending of our marketing bulletin and informational notices and advertisements regarding our products or services that might fit your interests, including by computerised means, including but not limited to email, SMS and WhatsApp.

– Legitimate interests: Your consent upon signing up for our marketing notices and/or newsletters.

– Conservation: Until the interested party revokes the consent and requests to be unsubscribed from the service.


FORM FOR PAYMENT OF PURCHASES:

– Purpose: For the correct management of the business relationship with you, which includes: the management of your orders, sending to the address you indicated, answering your questions regarding your orders and interacting with you, processing and follow-up of your order or administering the payment of your order, as well as for the sending of our marketing bulletin and informational notices on our products and services, including by computerised means.

– Legitimate interests: Your express consent. Acceptance of the Terms and Conditions.

– Conservation: Until the data’s deletion is requested.

The payment information (credit card number / PayPal information / bank account details) is not collected by us, but directly by the payment service providers.


SENDING OF EMAILS:

– Purpose: To respond to your requests for information, see to your requests and answer your queries or issues. In the event your CV is received, your personal data and professional CV information may be added to our databases in order to participate in our present and future recruiting activities.

– Legitimate interests: The user’s consent upon requesting information through the email address or when sending us information and CV in order to participate in our recruiting activities.

– Conservation: Once your request is answered by email, if no new treatment was generated. In the case of receiving your CV, your data may be stored for a maximum of one year for future recruitment activities.

It is possible that we retain some personal data in order to comply with our legal or regulatory obligations, as well as to administer our rights (for example, in order to file claims with courts) or for statistical or historic purposes.

When we no longer need to use your personal data, it will be deleted from our systems and records and will be anonymized.


Obligation to provide us with your personal data and consequences for not doing so.

The provision of personal data requires a minimum age of 14 years old or, where applicable, having sufficient legal capacity to sign up.

The personal data requested are necessary in order to manage your requests and/or provide you with the services that you may contract, for which, if you do not provide it to us, we will not be able to correctly attend to you or render you the service you have requested.

In all cases, we reserve the right to decide whether your personal data, as well as other information, will be entered into our databases.


4. RECIPIENTS OF YOUR DATA

We sign contracts with trusted third parties so these can carry out a variety of business operations on our behalf. We only provide them with the information they need to execute the service, and we demand that they do not use your personal data for any other purpose whatsoever. We always make our best efforts to guarantee that all the third parties with which we work maintain the security of your personal data.

Likewise, the Personal Data we collect may be sent to:

– Payment service providers and credit reference agencies for the purpose of verifying your details when this is a condition to sign a contract with you.

– Third parties that help us provide IT services, such as providers of platforms, storage solutions, maintenance and support for our databases, as well as support for our software and applications that could contain data on you.

– Advertising, marketing and digital media agencies in order to help us offer ads, marketing and campaigns, to analyse their effectiveness and to manager your contact and your questions.

– Third parties that help us provide digital and e-commerce services such as CRM, web analytics and search engines, amongst others.

– Service providers located outside the European Economic Area such as Google, LLC may access your personal data. These service providers are under a Privacy Shield and are therefore obliged to protect your personal data pursuant to a series of protection and safeguarding standards as defined by the European Union.


5. RIGHTS RELATED TO YOUR PERSONAL DATA

Any person may withdraw their consent at any time, when this was granted for the processing of their data. Under no circumstances does the withdrawal of this consent condition the execution of the subscription contract or the relations generated prior to the withdrawal of consent.

He or she may likewise exercise the following rights:

• Request access to their personal data or its correction when this is inaccurate.

• Request its deletion when, amongst other reasons, the data is no longer necessary for the purposes for which it was collected.

• Request the limitation of its processing in certain circumstances.

• Request the opposition to the processing of their data due to reasons related to their particular situation.
• Request the portability of the data in the cases established by the regulations.
• Other rights recognised in the applicable regulations.

Where and how to request your right of consent withdrawal: Through a written letter sent to ITPRI at its mailing address or email address (indicated in Point 1), stating the reference “Personal Data”, specifying the right wished to be exercised and with respect to which personal data.


6. SECURITY OF YOUR PERSONAL DATA

For the purpose of safeguarding the security of your personal data, we inform you that we have adopted all the technical and organizational measures necessary in order to guarantee the security of the personal data provided from its alteration, loss or unauthorised processing or access.


7. UPDATING OF YOUR DATA

For us to be able to keep your personal data updated, it is important that we always inform you when there has been any modification whatsoever to this data, otherwise we will not be responsible for its veracity.

We will not be held responsible for the Privacy Policy with respect to personal data provided to third parties by means of links available on our webpage.


8. CONTACT

If you have any issue or query regarding the manner in which we process and use your personal data or wish to execute any of the rights described above, please contact info@reschedulepsilocybin.org.

9. COOKIES AND ANALYTICS

This website uses cookies and data analysis software to track users’ behavior. Users of the site must explicitly accept the use of cookies to navigate the site.

If you leave a comment on our site you may opt-in to saving your name, email address and website in cookies. These are for your convenience so that you do not have to fill in your details again when you leave another comment. These cookies will last for one year.

Google Analytics is a web analytics service. Web analysis is the gathering, collection and analysis of data about the behavior of visitors to websites. Among other things, a web analysis service collects data on which website a data subject has come to a website from (so-called referrers), which subpages of the website were accessed or how often and for which period of time a subpage was viewed. A web analysis is mainly used to optimize a website and for the cost-benefit analysis of Internet advertising.

The operator of the Google Analytics component is Google Inc., 1600 Amphitheatre Pkwy, Mountain View, CA 94043-1351, USA.

Google Analytics uses cookies. The information generated by the cookie about your use of this website is usually transmitted to a Google server in the USA and stored there. Google might transfer the personal information collected via this technical procedure to third parties.

As IP anonymization is activated on our website, your IP address will be shortened by Google within Member States of the European Union or other states in agreement with the European Economic Area. Only in exceptional cases, the full IP address is sent to and shortened by a Google server in the USA. On behalf of the operator of the website, Google will use this information to evaluate your use of the website, compile reports on website activity and to provide further services related to website and internet use to us. The IP address transferred through your browser to Google Analytics will not be combined with other data held by Google.

In addition, this website uses the Analytics feature UserID to track interaction data. This User ID will be additionally anonymized and encrypted and will not be linked with other data.

You can prevent the storage of cookies by a corresponding setting of your browser software; however, please note that if you do this, you may not be able to use all the features of this website to the fullest extent possible.

In addition, you may prevent the collection of the data generated by the cookie and related to your use of the website (including your IP address) by Google as well as the processing of this data by Google by downloading and installing the browser plug-in available under the following link: https://tools.google.com/dlpage/gaoptout?hl=en
This browser add-on informs Google Analytics via JavaScript that no data and information about website visits may be transmitted to Google Analytics.
In addition, a cookie already set by Google Analytics can be deleted at any time via the Internet browser or other software programs.

Further information and Google‘s applicable privacy regulations can be found at https://policies.google.com/privacy?hl=en and  The following link provides a further explanation of Google Analytics https://marketingplatform.google.com/about/.

Our website also uses Google Analytics performance reports relating to demographics and interests and reports on Google Display Network impressions. You can disable Google Analytics for display advertising and customize the ads on the Google Display Network by visiting the ad settings at this link: https://adssettings.google.com.

Please note that the content described in this website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please conduct your own research and due diligence and speak with a medical professional before making any major health changes.


Contact Us

info@reschedulepsilocybin.org

+41 (79) 434 25 78

Frohburgstrasse 36B 8832 Wollerau, Switzerland

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