What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Traumatic Brain Injury (TBI) that involve psychedelics, such as Enhanced Psilocybin Micro-dosing, often interact with the 5-HT2A receptor to promote new neural pathways and reroute neurotransmitters. Known side effects of psilocybin include transient anxiety, confusion, dizziness, nausea, and hallucinations, which are typically short-lived. Long-term side effects may include changes in mood and perception. Similar treatments like ketamine can cause dissociation, dizziness, and increased blood pressure. These treatments require careful monitoring to manage side effects effectively.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Traumatic Brain Injury (TBI) that function through mechanisms similar to enhanced psilocybin micro-dosing, which promotes new neural pathways and reroutes neurotransmitters via 5-HT2A receptor interaction. Current FDA-approved treatments for TBI primarily focus on symptom management and rehabilitation rather than neurogenesis or neurotransmitter rerouting. However, research into the use of psychedelics like psilocybin for various neurological and psychiatric conditions is ongoing, and future approvals may emerge as evidence of their efficacy and safety grows.

What other types of research exist?

Promising, novel alternatives to Enhanced Psilocybin Micro-dosing for Traumatic Brain Injury patients in 2024 include cannabinoid treatments (particularly cannabidiol), transcranial magnetic stimulation (TMS), and N-acetylcysteine (NAC). These therapies have shown potential in promoting neural pathway development and neurotransmitter rerouting.

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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

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Oropharyngeal pain

Suicidal Ideation

Insomnia

Influenza

Depression

Diarrhea

Headache

Sinus headache

Depressed mood

Lower resp. tract congestion

Alcohol withdrawal syndrome

Rhinorrhea

Musculoskeletal pain

Oedema

Pyrexia

Peripheral swelling

Restlessness

Vomiting

Fungal infection

Hypoesthesia

Thrombocytosis

Eye infection

Constipation

Dermatitis contact

Bronchitis bacterial

Traumatic lung injury

Hyponatremia

Arthralgia

Pain in extremity

Dizziness

Migraine

Sedation

Anger

Anxiety

Cough

Sexual abuse

Sinus congestion

Malignant melanoma

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

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.

Do I qualify?Apply below to find out

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.