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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether small, controlled doses of psilocybin (a compound found in certain mushrooms) can aid individuals with conditions such as PTSD, chronic depression, and long COVID. Researchers aim for psilocybin to create new brain pathways, potentially reducing distressing symptoms that standard medications have not fully addressed. Participants will test different dosing strategies to determine if psilocybin is more effective than current treatments. Those who may be suitable have long-standing trauma or related conditions that have not improved with usual treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that psilocybin, a substance found in certain mushrooms, is being studied for its safety and effectiveness in treating mental health issues. Some studies suggest that psilocybin may help reduce symptoms of PTSD (Post-Traumatic Stress Disorder) and depression. For example, early findings indicate that a single dose of psilocybin, when combined with therapy, can lessen PTSD symptoms in some people.

In another study on safety and potential misuse, researchers at Johns Hopkins found that psilocybin did not pose major safety risks when used in a controlled environment. It is considered safe when monitored by professionals. However, it's important to remember that while the results are promising, psilocybin's use in medical settings is still under careful study. Some study participants reported mild side effects, such as temporary anxiety or changes in perception.

In this trial, psilocybin is given in microdoses, which are small amounts meant to avoid the strong effects of larger doses. This approach aims to capture potential benefits while reducing risks. Since this is an early-stage trial, the main goal is to assess safety and how well participants tolerate it. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using psilocybin for trauma because it offers a unique approach compared to traditional treatments like SSRIs (Selective Serotonin Reuptake Inhibitors). Unlike SSRIs, which typically take weeks to have an effect, psilocybin can potentially provide quicker relief by acting on serotonin receptors in a different way, promoting neuroplasticity and emotional processing. Moreover, psilocybin is administered in precise, controlled doses that can be tailored to each participant's needs, ranging from microdoses to a more substantial monthly dose. This method could offer a more personalized and potentially more effective treatment option for those struggling with trauma.

What evidence suggests that this trial's treatments could be effective for trauma?

Research has shown that psilocybin can aid in addressing mental health issues such as PTSD and depression. In a study with U.S. military veterans, 60% of participants who took a single dose of psilocybin experienced a significant reduction in symptoms after three weeks. About 53% even reached remission, meaning their symptoms were no longer noticeable. By 12 weeks, 47% still felt better, and 40% remained in remission. In this trial, participants will be assigned to different treatment arms involving psilocybin. One arm involves a psychiatrist reducing SSRIs and replacing them with psilocybin. Another arm includes a tailored dose of psilocybin administered every Monday, Wednesday, and Friday, with a larger monthly dose. Psilocybin affects serotonin, a brain chemical that influences mood and anxiety, and can help form new connections in the brain. This process is thought to help the brain manage and heal from trauma more effectively. ^{1 2 5 6 7}

Who Is on the Research Team?

Ross M Allison, Provider

Principal Investigator

NW Therapies Trauma Unit

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/psychedelics_assisted_therapy.asp

Psychedelic-Assisted Therapy for PTSD Finally, preliminary data suggests that a single administration of psilocybin along with group psychotherapy can decrease symptoms of PTSD in older long-term ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10845102/

The Psychedelic Future of Post-Traumatic Stress Disorder ... Though they did not specifically measure trauma history or PTSD symptoms, outcome data indicate improvements in psychological well-being using this measure ...

3. hopkinsmedicine.org hopkinsmedicine.org/psychiatry/research/psychedelics-research

Psychedelics Research and Psilocybin Therapy Upcoming studies will determine the effectiveness of psilocybin as a new therapy for opioid addiction, Alzheimer's disease, post-traumatic stress disorder (PTSD) ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12230355/

Exploring the Therapeutic Effects of Psychedelics ... Psilocybin and ayahuasca retreats significantly improved veterans' mental well‐being, quality of life, PTSD, anxiety, depression, sleep, ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032724016227

Single-dose psilocybin for U.S. military Veterans with ... Of 15 participants, 60 % met response and 53 % met remission criteria at Week 3. At 12 weeks, 47 % maintained response, and 40 % remission. Co- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12146596/

Clinical conceptualisation of PTSD in psilocybin treatment Finally, we offer recommendations for the safe administration of psilocybin for traumatised patients in medical research settings, emphasising ...

7. med.nyu.edu med.nyu.edu/departments-institutes/population-health/divisions-sections-centers/medical-ethics/education/high-school-bioethics-project/learning-scenarios/ptsd-treatment-psychedelics

Post-Traumatic Stress Disorder Treatment with Psychedelic ... There are reasons why psilocybin could be a safe and effective treatment for PTSD. What are the benefits and risks of approving such a treatment? Benefits of ...