Northwest Therapies Trauma Psilocybin Study Compassionate Use Study

NCT05042466 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: NWTTPS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. Enchanced Psilocybin micro-dosing at the levels of 0.15g. ranging to 0.33g. every other day an 0.50g. for monthly maintenance of neural pathway production 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 additional natural pathway in place then to decrease/stop these thoughts by have open pathways to process the thought differently. Serotonin is a neurotransmitter and 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 psilocybin at the levels of 0.15 to 0.33 and of 1 gram to 1.5 grams monthly for maintenance of the newly opened neural pathways is postulated to be a mental health game changer. 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 process the subconscious held in the subconscious and shave back the somatic feelings resulting from the trauma of the individuals who have on-boarded chronic disease(s) of Trauma,PTSD, Unregulated Chronic Depression, MS, Cancer, HIV, and SARS-CoV-2- Long Haulers Syndrome.

Conditions

Trauma, Nervous System

Keywords

Trauma; HIV; MS; SARs-Cov-2; Psilocybin; Microdose; Highjacked Nervous System; Cancer; Depression; PTSD

Outcome Measures

Primary Outcomes (2)

• GAF Score

  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.

  8 weeks

• BAM Score

  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.

  8 weeks

Secondary Outcomes (1)

• PLC-5 Score

  8 weeks

Study Arms (4)

Plant Medicine On Boarding

EXPERIMENTAL

The participant will partner with psychiatrist to reduce SSRI's and on-board psilocybin, every M/W/F with a tailored dose of plant medicine psilocybin in the enhanced micro dose levels or 0.15g. to 0.33g with a monthly 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

Participant

EXPERIMENTAL

0.15g. thru 0.33g. tailored to participant, then Monthly a 1 time dose of 1gram to 1.5 grams dose of non-synthesized plant medicine psilocybin.

Drug: Trauma

Psychiatrist

EXPERIMENTAL

Psychiatrist QC scaling back SSRI's replacing with psilocybin.

Drug: Trauma

On-Boarding Plant Medicine Specialist

EXPERIMENTAL

The On-Boarding Provider will control dosage of the plant medicine via Telehealth.

Drug: Trauma

Interventions

Trauma DRUG

0.15g. thru 0.33g., M/W/F and monthly 1 time a dose of 1g. to 1.5g monthly. 8 week trial.

Also known as: psilocybin

On-Boarding Plant Medicine Specialist; Participant; Plant Medicine On Boarding; Psychiatrist

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Psychiatrist, LCPC Therapist, Administrator, On Boarding Plant Medicine Specialist.
• Informed Consent

You may not qualify if:

• Cardiovascular Complication

Sponsors & Collaborators

• NWTraumatherapies: lead
• World Health Organization: collaborator

Study Sites (1)

Ross Allison NPI #1437519899 Administrator Of Study

Bozeman, Montana, 59718, United States

Location

MeSH Terms

Conditions

Trauma, Nervous System; Wounds and Injuries; Neoplasms; Depression; Stress Disorders, Post-Traumatic

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Nervous System Diseases; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Ross M Allison, Provider

  NW Therapies Trauma Unit

  STUDY DIRECTOR

Central Study Contacts

Ross M Allison, Plant Medicine On Boarding

CONTACT

206-234-3087; geriatric.bozemanhealth@gmail.com

Ross M Allison, Provider NPI 1437519899

CONTACT

206-234-3087; practitioner.lmp.lifeenergy@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participant, Providers
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Phase 1, 8 week time frame, M/W/F 0.15 to 0.33G, tailored dose of non synthesized psilocybin. A Monthly dose of 1 gram to 1.5 grams psilocybin. QC, controllers, Psychiatrist, LCPC Therapist, Plant Medicine On Boarding Specialist.

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 13, 2021
• Study Start: September 3, 2023
• Primary Completion: August 30, 2025
• Study Completion: October 3, 2025
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

US (1)