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Psychedelic
Psilocybin for Trauma (NWTTPS Trial)
Phase 1
Waitlist Available
Research Sponsored by NWTraumatherapies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the use of psilocybin microdosing to help patients with chronic illnesses like PTSD and depression. Psilocybin, found in certain mushrooms, helps the brain form new pathways, reducing negative thoughts. This approach targets patients who don't respond well to traditional treatments. Psilocybin has shown promise as a treatment for major depressive disorder and was designated as breakthrough therapy by the FDA.
Who is the study for?
This trial is for individuals with traumatic brain injury or wounds who have chronic conditions like PTSD, depression, MS, HIV, and Long Haulers Syndrome. Participants must consent to the study and be evaluated by a psychiatrist or therapist. Those with cardiovascular complications cannot join.
What is being tested?
The study tests enhanced micro-dosing of psilocybin (a compound similar to serotonin) for trauma patients. Doses range from 0.15g to 0.33g every other day and up to 1.5 grams monthly for maintenance, aiming to create new neural pathways and alleviate symptoms.
What are the potential side effects?
Possible side effects of psilocybin may include changes in sensory perception, mood alteration, nausea, headache, increased heart rate and blood pressure; however individual experiences can vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
BAM Score
GAF Score
Secondary study objectives
PLC-5 Score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: PsychiatristExperimental Treatment1 Intervention
Psychiatrist QC scaling back SSRI's replacing with psilocybin.
Group II: Plant Medicine On BoardingExperimental Treatment1 Intervention
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.
Group III: ParticipantExperimental Treatment1 Intervention
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.
Group IV: On-Boarding Plant Medicine SpecialistExperimental Treatment1 Intervention
The On-Boarding Provider will control dosage of the plant medicine via Telehealth.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Traumatic Brain Injury (TBI) often focus on promoting neural plasticity and regulating neurotransmitter activity. Enhanced psilocybin micro-dosing, for example, interacts with 5-HT2A receptors to promote the formation of new neural pathways and reroute neurotransmitter activity, which can alleviate symptoms of depression and anxiety.
Other treatments include SSRIs, which increase serotonin levels to improve mood and cognitive function, and neurorehabilitation therapies that enhance brain plasticity through physical and cognitive exercises. These mechanisms are crucial for TBI patients as they directly impact recovery by improving mood, cognitive function, and overall brain health.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
NWTraumatherapiesLead Sponsor
World Health OrganizationOTHER
235 Previous Clinical Trials
1,455,870 Total Patients Enrolled
Ross M Allison, ProviderStudy DirectorNW Therapies Trauma Unit
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It seems like the criterion you have provided is a list of different job titles or roles, but it is not clear what the exclusion criteria is. Can you please provide more context or clarify the information?I have a heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: On-Boarding Plant Medicine Specialist
- Group 2: Psychiatrist
- Group 3: Plant Medicine On Boarding
- Group 4: Participant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Neurotmesis Patient Testimony for trial: Trial Name: NCT05042466 — Phase 1
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