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Northwest Therapies Trauma Psilocybin Study Compassionate Use Study (NWTTPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05042466
Recruitment Status : Not yet recruiting
First Posted : September 13, 2021
Last Update Posted : December 3, 2021
Sponsor:
Collaborators:
Imperial College London
World Health Organization
Information provided by (Responsible Party):
NWTraumatherapies

Tracking Information
First Submitted Date  ICMJE August 24, 2021
First Posted Date  ICMJE September 13, 2021
Last Update Posted Date December 3, 2021
Estimated Study Start Date  ICMJE January 6, 2022
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2021)
  • GAF Score [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2021)
PLC-5 Score [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Northwest Therapies Trauma Psilocybin Study Compassionate Use Study
Official Title  ICMJE 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.
Brief Summary The on-boarding of unregulatable trauma in the United States has reached 20%, which1/5 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, HIV, and SARS-CoV-2- Long Haulers Syndrome. These chronic illness with unregulated trauma create an unstable portion of the population. Psychiatrists have testified before congress that the SSSRI medications are not functional cures and are not working for patients. Psilocybin micro-dosing is proving to shave back the highjacked nervous system, stopping ruminating neurotransmitter. The body has a natural path to stop these thoughts by a neurotransmitter called serotonin This is the most 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 ). Micodosing 1 gram to 1/5 grams of psilocybin 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, and SARS-CoV-2- Long Haulers Syndrome.
Detailed Description

Patients will work with a team: The Administrator Of Study, Psychiatrist, Therapist LCPC, Micro Dosing Advisor/On-Boarding Provider.

The dosage will be 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, and SARS-CoV-2- Long Haulers Syndrome. The participants with unregulated trauma tend have a severely compromised unfunctional compromised immune system. This compromised low functioning compromised immune system creates additional health crisis and cost a great deal of money. As testified to congress, the SSSRI's are not able to manage the on boarding of severe trauma.

Working in conjunction with the psychiatrist, LCPC, and Micro Dosing Advisor/On-Boarding Provider this study will shave back the SSRI's and treat with dosing of 1 to 1.5 grams of Plant Medicine Psilocybin every other day for 8 weeks.

The on-boarding of unregulatable trauma in the United States has reached 20%, which1/5 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, HIV, and SARS-CoV-2- Long Haulers Syndrome. These chronic illness with unregulated trauma create an unstable portion of the population. Psychiatrists have testified before congress that the SSSRI medications are not functional cures and are not working for patients. Psilocybin micro-dosing is proving to shave back the highjacked nervous system, stopping ruminating neurotransmitter. The body has a natural path to stop these thoughts by a neurotransmitter called serotonin This is the most 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 ). Micodosing 1 gram to 1/5 grams of psilocybin 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, and SARS-CoV-2- Long Haulers Syndrome.

Ross Allison Administrator NPI#1437519899

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Participant, Providers
Primary Purpose: Treatment
Condition  ICMJE Trauma, Nervous System
Intervention  ICMJE Drug: Trauma
1 gram, every other day, 8 week trial
Other Name: psilocybin
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Trauma
  • Experimental: Participant
    1gram to 1.5 grams psilocybin
    Intervention: Drug: Trauma
  • Experimental: Psychiatrist
    Psychiatrist QC scaling back SSRI's replacing with psilocybin.
    Intervention: Drug: Trauma
  • Experimental: On-Boarding Plant Medicine Specialist
    The On-Boarding Provider will control dosage of the plant medicine.
    Intervention: Drug: Trauma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 6, 2021)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2024
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Psychiatrist, LCPC Therapist, Administrator, On Boarding Plant Medicine Specialist.

Informed Consent

Exclusion Criteria:

Cardiovascular Complication

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ross M Allison, Plant Medicine On Boarding 206-234-3087 geriatric.bozemanhealth@gmail.com
Contact: Ross M Allison, Provider NPI 1437519899 206-234-3087 practitioner.lmp.lifeenergy@gmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05042466
Other Study ID Numbers  ICMJE NWTTPS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NWTraumatherapies
Study Sponsor  ICMJE NWTraumatherapies
Collaborators  ICMJE
  • Imperial College London
  • World Health Organization
Investigators  ICMJE
Study Director: Ross M Allison, Provider NW Therapies Trauma Unit
PRS Account NWTraumatherapies
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP