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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
NWTTPS Trial Summary
This trial is testing whether psilocybin can help people with chronic illnesses who are also experiencing unregulated trauma.
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.Check my eligibility
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.See study design
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.
NWTTPS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
BAM Score
GAF Score
Secondary outcome measures
PLC-5 Score
Side effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Fungal infection
2%
Vomiting
2%
Rhinorrhea
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin
NWTTPS 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.
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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
233 Previous Clinical Trials
1,566,243 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.
Traumatic Brain Injury Patient Testimony for trial: Trial Name: NCT05042466 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment rate for this clinical experiment?
"Unfortunately, this clinical trial has since concluded its recruitment phase. It was first posted on the 3rd of September 2023 and last edited on 11th November 2022. However, there are presently 743 trials for axonotmesis with active participant enrolment as well 33 studies currently recruiting patients suffering from trauma-related issues."
Answered by AI
How does Trauma impact individuals physiologically and psychologically?
"Since this is a Phase 1 trial, which has limited evidence for its efficacy and safety, Power assigned Trauma a score of 1."
Answered by AI
Is the call for participants still open for this experiment?
"According to clinicaltrials.gov, this medical study has ceased recruitment as of November 7th 2022 - the last time it was edited. Despite that, there are still 776 other trials actively recruiting patients from across the globe at present."
Answered by AI
Are those aged 40 and above eligible for inclusion in this research endeavor?
"Consistent with the trial's conditions for participation, those 21 or older and younger than 100 are eligible to enroll."
Answered by AI
Who is qualified to participate in this research endeavor?
"Prospective participants need to meet the requirements of axonotmesis and be between 21-99 years old in order to join this clinical trial. The total number of enrollees is capped at 30 people."
Answered by AI
Have any prior experiments explored the effects of Trauma?
"Presently, 33 diverse research studies into Trauma are being conducted. None of these experiments have progressed to phase 3 as yet; however, the majority of them take place in Vancouver, Washington with 36 other sites also running trials for this form of treatment."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
Pennsylvania
Montana
Other
How old are they?
65+
18 - 65
What site did they apply to?
Ross Allison NPI #1437519899 Administrator Of Study
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
0
Why did patients apply to this trial?
I have been researching safe methods of treating PTSD without harmful drugs. I have researched psilocybin and feel strong Lu that it may be helpful. After multiple therapies. That may be beneficial.
PatientReceived 1 prior treatment
I’m considering using psilocybin on my own. It is now decriminalized in Colorado. I would prefer to donate as a volunteer to legitimate medical research, and I would prefer the medical oversight of such activity. My career was involving biomedical research so I’m enthusiastic about learning and contributing.
PatientReceived 1 prior treatment
I have been having problems with TBI symptoms and ptsd from a very active lifestyle including fighting, skate boarding, football, and construction work. I have had numerous concussions including a major concussion with short term memory issues resulting from a 25 foot fall. I have migraine headaches. I have been studying the effects of psilocybin and feel like I need to try it. I want to do it legally and trials seem to be the best way to do that.
PatientReceived no prior treatments
I HAVE SLOWLY FELL DOWNHILL SINCE THE INJURY BUT THE PAST TWO YEARS IS LIKE ITS HAPPENING AT warp speed , so scary I cannot form the words.. I have worked with many modalities yet really didnt start with helping my brain until I was 46. I am truly fearful of the outcome as things having taken such a dark plunge. I would drive anywhere to get help that may actually work. the trials and research I have read over the years make it out like this is a no-brainer as far as the numbers on how well they did. Please let me know what this entails. Thank you!
PatientReceived no prior treatments
What questions have other patients asked about this trial?
If I’m chosen and end up in a placebo group will I have the chance to be in another group later in the study?
PatientReceived 2+ prior treatments
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