NWTTPS: Northwest Therapies Trauma Psilocybin Study Compassionate Use Study

Sponsor

NWTraumatherapies (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05042466

Collaborator

World Health Organization (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The on-boarding of unregulatable trauma in the United States has reached 20%, which is 1/5 of the population. A population of this magnitude, by definition has now reached an epidemic classification. The population with chronic illness as stated: PTSD, Chronic Depression, MS, HIV, and SARS-CoV-2- Long Haulers Syndrome. These chronic conditions/illnesses many lead to death and are often the cause or perpetuate unregulated trauma and create an unstable population. Psychiatrists have testified before congress that the SSSRI medications are not fully functional cures and are not working for patients. Psilocybin micro-dosing is proving to shave back the highjacked nervous system, thus stopping or rerouting the ruminating neurotransmitters, by rerouting thru new neural pathways. The body has a natural path to decrease/stop these thoughts by a neurotransmitter Serotonin which is the most famous of all the neurotransmitters. Serotonin is very similar in its compound structure to the plant medicine family of psilocybin, serotonin and psilocybin work very similarly with the 5h2A receptor in the human cortex ( the outer cortex of the brain ). Enhanced Microdosing of 1 gram to 1.5 grams of psilocybin helps shave back the highjacked nervous system which is a condition known as the diagnosis (SSD) Somatic Symptom Disorder. This research is believed accurate by proof on previous studies to reverse back the somatic feelings resulting from the trauma of the individuals who are on boarding chronic diseases of PTSD, Chronic Depression, MS, Cancer, HIV, and SARS-CoV-2- Long Haulers Syndrome.

Condition or Disease	Intervention/Treatment	Phase
Trauma, Nervous System	Drug: Trauma	Phase 1

Detailed Description

Patients will work with a team: The Administrator Of Study, participants will be onboarded into the study by a Psychiatrist, Therapist LCPC, Micro Dosing Advisor/On-Boarding Provider, going forward referred to as a PMOP ( PLANT MEDICINE ON-BOARDING PROVIDER. The PMOP will administrate, chart dosing and file reports with the Psychiatrist, General Provider, Psychologist, or the LCPC Therapist. Adding a PMOP to Western Medicine could be the key to making treatment available at a functional cost.

The dosage will be ( enhanced micro-dosing which is 1 gram to 1.5 grams of psilocybin every other day for 8 weeks.

Patients will be accepted in the study they must present with one of the following diagnosed conditions, chronic illness' of PTSD, Chronic Depression, MS, HIV, Cancer, or SARS-CoV-2- Long Haulers Syndrome. As participants with unregulated trauma can tend to have a severely compromised un-functional compromised immune system. This compromised low functioning compromised immune system creates additional health crisis and can cost a great deal of money for the patients and the healthcare system. As testified to congress, the SSSRI's are not fully able to manage the on boarding of severe trauma resulting often in PTST/Trauma and is currently being managed at great human cost and financial cost for a decade or more for many patients. Working in conjunction with the General Provider, Psychiatrist, Psychologist, and LCPC Therapist, with a PMOP( Micro Dosing Provider, On-Boarding Provider may result in the Quality of Life and or result in Dying Well. As Stated this study is looking for evidence this Plant Medicine Psilocybin would become a path to shave back the SSRI's and treat with dosing of 1 to 1.5 grams of Plant Medicine. This Study will introduce Psilocybin every other day for 8 weeks.

The on-boarding of unregulatable trauma in the United States has reached 20%, which is 1/5 of the population. A population of this magnitude, by definition has reached an epidemic classification. The population with chronic illness as stated: PTSD, Chronic Depression, MS, Caner, HIV, and SARS-CoV-2- Long Haulers Syndrome, these conditions are severe and the treatments are often not effective. These chronic illnesses which can result in unregulated trauma create an unstable portion of the population. Psychiatrists have testified before congress that the SSSRI medications are not functional cures and are often not working for patients. Psilocybin micro-dosing by many studies is proving to shave back the highjacked nervous system, stopping or rerouting the neural pathways lessening or stopping the ruminating neurotransmitters. The body has a natural path to stop these thoughts by a neurotransmitter called serotonin This famous neurotransmitter Serotonin, is very similar to the plant medicine family of psilocybin, Serotonin and psilocybin work very similarly with the 5h2A receptor in the human cortex ( the outer cortex of the brain ). Enhanced Microdosing of 1 gram to 1.5 grams of psilocybin which helps shave back the highjacked nervous system known as the diagnosis (SSD) Somatic Symptom Disorder. This research is believed accurate by proof on previous studies to reverse back the somatic feelings resulting from the trauma of the individuals who are on boarding chronic diseases of PTSD, Chronic Depression, MS, HIV, Cancer, and SARS-CoV-2- Long Haulers Syndrome.

Ross Allison Administrator NPI#1437519899

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Phase 1, 8 week time, every other day 1 gram to 1.5 grams psilocybin. QC, controllers, Psychiatrist, LCPC Therapist, Plant Medicine On Boarding Specialist.Phase 1, 8 week time, every other day 1 gram to 1.5 grams psilocybin. QC, controllers, Psychiatrist, LCPC Therapist, Plant Medicine On Boarding Specialist.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Participant, Providers

Primary Purpose:

Treatment

Official Title:

NW Trauma Therapies, Chronic Illness of Chronic Depression, PTSD, MS, HIV, and SARS-CoV-2, Long Haulers Syndrome. Treatment of Unregulaaible Trauma by the Treatment of Micro Dosing Psilocybin to Regulate the Highjacked Nervous System.

Anticipated Study Start Date :

May 3, 2022

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

May 3, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Plant Medicine On Boarding The participant will partner with psychiatrist to reduce SSRI's and on-board psilocybin, every other day dose of 1 gram to 1.5 grams .Study Status, Oversight, Study Design, Outcome Measures, Eligibility, and informed consent will all be metrics of this study.	Drug: Trauma 1 gram, every other day, 8 week trial Other Names: psilocybin
Experimental: Participant 1gram to 1.5 grams psilocybin	Drug: Trauma 1 gram, every other day, 8 week trial Other Names: psilocybin
Experimental: Psychiatrist Psychiatrist QC scaling back SSRI's replacing with psilocybin.	Drug: Trauma 1 gram, every other day, 8 week trial Other Names: psilocybin
Experimental: On-Boarding Plant Medicine Specialist The On-Boarding Provider will control dosage of the plant medicine.	Drug: Trauma 1 gram, every other day, 8 week trial Other Names: psilocybin

Outcome Measures

Primary Outcome Measures

GAF Score [8 weeks]
GAF scoring system, Psychiatrist, LCPC Therapist, Administrator, On Boarding Plant Medicine Specialist, and Participant. will individually submit assessments monthly. A metrics of all 4 reports will be the result. QC measure to ensure the research participant is safe.
BAM Score [8 weeks]
BAM, Brief Addiction Monitor, As psilocybin in all studies has shown not to be addictive. This study has in place a monthly BAM score by thePsychiatrist, LCPC Therapist, Administrator, On Boarding Plant Medicine Specialist. This BAM score will be done Monthly by all 4 listed persons. The metric of the combined scores will be the result. This QC measure is to protect the participant.

Secondary Outcome Measures

PLC-5 Score [8 weeks]
PLC-5 score resulting in 1. Monitoring symptom change during and after the treatment. 2. Screeing for PTSD. 3. Making a provisional PTSD Diagnosis. All 4 providers will complete this score monthly. The metric of the 4 providers will result the score.