← Back to Search

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 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

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 • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Influenza
4%
Oropharyngeal pain
4%
Insomnia
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Peripheral swelling
2%
Pyrexia
2%
Oedema
2%
Rhinorrhea
2%
Fungal infection
2%
Musculoskeletal pain
2%
Hypoesthesia
2%
Restlessness
2%
Vomiting
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.

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.

Find a Location

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

Trauma (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05042466 — Phase 1
Traumatic Brain Injury Research Study Groups: On-Boarding Plant Medicine Specialist, Psychiatrist, Plant Medicine On Boarding, Participant
Traumatic Brain Injury Clinical Trial 2023: Trauma Highlights & Side Effects. Trial Name: NCT05042466 — Phase 1
Trauma (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05042466 — Phase 1
Traumatic Brain Injury Patient Testimony for trial: Trial Name: NCT05042466 — Phase 1
~18 spots leftby Aug 2025