Psilocybin for Trauma

(NWTTPS Trial)

Overseen By Ross M Allison, Plant Medicine On Boarding

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NWTraumatherapies

Disqualifiers: Cardiovascular complications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug psilocybin for treating trauma?

Research suggests that psilocybin, found in 'magic mushrooms', has shown promise in treating mental health issues like major depressive disorder and addiction, which are often related to trauma. While specific data on trauma is limited, the positive effects seen in these related conditions suggest potential benefits for trauma treatment. ^{1 2 3 4 5}

Is psilocybin generally safe for humans?

Psilocybin has been studied for safety in various conditions, showing that while some people may experience challenging experiences or mild side effects, serious adverse events are rare when used in controlled settings with proper support. In studies, most side effects were mild and resolved quickly, and the risk of enduring psychological distress is low when participants are screened and supported. ^{3 6 7 8 9}

How does the drug psilocybin differ from other treatments for trauma?

Psilocybin is unique because it is a psychedelic compound that may help treat trauma by promoting neuroplasticity (the brain's ability to change and adapt) and facilitating fear extinction, which are not typical mechanisms of action for standard PTSD treatments. Unlike many current treatments, psilocybin is administered in a few sessions and has shown potential for long-term improvements even in treatment-resistant cases. ^{1 8 10 11 12}

Research Team

Ross M Allison, Provider

Principal Investigator

NW Therapies Trauma Unit

Eligibility Criteria

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.

Inclusion Criteria

Administrator

On Boarding Plant Medicine Specialist

Psychiatrist

Exclusion Criteria

I have a heart condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

On-boarding

Participants are onboarded into the study by a team including a Psychiatrist, Therapist, and Micro Dosing Advisor

2 weeks

Telehealth sessions

Treatment

Participants receive enhanced micro-dosing of psilocybin every other day for 5 days, then M/W/F for 8 weeks

8 weeks

Regular telehealth check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Trauma

Trial Overview 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.

Participant Groups

Group I: Psychiatrist Experimental Treatment 1 Intervention

Psychiatrist QC scaling back SSRI's replacing with psilocybin.

Group II: Plant Medicine On Boarding Experimental Treatment 1 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: Participant Experimental Treatment 1 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 Specialist Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

NWTraumatherapies

Lead Sponsor

Trials

1

Recruited

30+

World Health Organization

Collaborator

Trials

236

Recruited

1,620,000+

Findings from Research

Psilocybin, found in 'magic mushrooms', shows promise as a non-addictive alternative for treating mental health disorders like major depressive disorder and addiction, potentially addressing the urgent need for new therapies amid rising addiction and suicide rates.

Current research indicates that psilocybin may offer therapeutic benefits without the overdose risks associated with traditional mind-altering substances, suggesting a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin Therapeutic Research: The Present and Future Paradigm. Kargbo, RB.[2021]

In a study of 27 patients with moderate to severe major depressive disorder, psilocybin-assisted treatment showed significant and lasting antidepressant effects, with 75% of participants experiencing a treatment response and 58% achieving remission after 12 months.

There were no serious adverse events related to psilocybin, indicating a favorable safety profile, and participants reported meaningful personal and spiritual experiences that correlated with increased well-being, although these did not directly predict improvements in depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. Gukasyan, N., Davis, AK., Barrett, FS., et al.[2022]

In a survey of 1993 individuals who experienced challenging psilocybin trips, 39% rated their experience as one of the most difficult of their lives, with 11% reporting risks of physical harm, particularly influenced by dose and lack of support.

Despite the challenges, 84% of respondents felt they benefited from the experience, suggesting that while adverse effects can occur, the overall incidence of serious psychological distress is low, especially in controlled settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. Carbonaro, TM., Bradstreet, MP., Barrett, FS., et al.[2018]

Psilocybin, a hallucinogenic compound found in certain mushrooms, has been associated with increasing rates of drug abuse, highlighting the need for comprehensive pharmacological understanding.

Despite its historical use in the 1960s for experimental medical purposes, recent research has only begun to uncover the pharmacological properties of psilocybin, indicating a gap in knowledge that needs to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin. Passie, T., Seifert, J., Schneider, U., et al.[2016]

In a phase II study involving 19 adults with treatment-resistant depression, a single 25 mg dose of synthetic psilocybin (COMP360) showed a significant reduction in depression scores, with a mean change of -14.9 on the MADRS scale after 3 weeks.

The treatment was generally safe, with 63.2% of participants experiencing mild treatment-emergent adverse events, but no serious adverse events or increased suicidal thoughts were reported, indicating a favorable safety profile for psilocybin in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication. Goodwin, GM., Croal, M., Feifel, D., et al.[2023]

A systematic review of 16 studies found that psilocybin is generally well-tolerated, with the most common side effects being transient nausea and headache, and no reports of severe long-term issues like psychosis.

Psilocybin shows promise as a safe treatment option for psychiatric and substance-dependence conditions, particularly for patients who do not respond to standard therapies, as it has demonstrated both acute and long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Tolerability and Safety of Psilocybin in Psychiatric and Substance-Dependence Conditions: A Systematic Review. Kaminski, D., Reinert, JP.[2023]

Psilocybin, a serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.

The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment with psilocybin: applications for patients with psychiatric disorders]. Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]

A single dose of psilocybin significantly reduced fear responses in mice, indicating its potential to facilitate fear extinction, which is crucial for treating PTSD.

Psilocybin promoted hippocampal neuroplasticity by improving dendritic complexity, spine density, and levels of neuroplasticity-related proteins, suggesting it could enhance the effectiveness of exposure-based therapies for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin facilitates fear extinction in mice by promoting hippocampal neuroplasticity. Du, Y., Li, Y., Zhao, X., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Psilocybin Therapeutic Research: The Present and Future Paradigm. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Hallucinogenic mushrooms. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The Tolerability and Safety of Psilocybin in Psychiatric and Substance-Dependence Conditions: A Systematic Review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Therapeutic use of psilocybin: Practical considerations for dosing and administration. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Psilocybin for Trauma-Related Disorders. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

[Treatment with psilocybin: applications for patients with psychiatric disorders]. [2021]

12. China pubmed.ncbi.nlm.nih.gov

Psilocybin facilitates fear extinction in mice by promoting hippocampal neuroplasticity. [2023]