Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder

(SUN004 Trial)

Overseen By Clinical Evaluation Team

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Sunstone Medical

Must be taking: SSRIs

Must not be taking: MAOIs

Disqualifiers: Male, Schizophrenia, Bipolar, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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 tests whether psilocybin, a psychedelic, can help treat PTSD (Post-Traumatic Stress Disorder) in cisgender women who have experienced sexual assault. The study aims to determine if a 25 mg dose of psilocybin, administered with therapy, is safe and effective for easing PTSD symptoms. Women who have had PTSD for at least six months due to sexual assault and are comfortable with therapy might be suitable candidates. Participants must be able to swallow pills, have a plan for safe transportation after sessions, and agree to some lifestyle changes during the trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking PTSD treatment advancements.

Will I have to stop taking my current medications?

The trial allows participants to continue taking SSRIs if they have been on a stable dose for at least 3 months. However, participants must stop taking monoamine oxidase inhibitors (MAOIs) before starting the trial. The protocol does not specify other medication restrictions, so it's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that psilocybin, when combined with psychological support, is generally safe and well-tolerated. In one study, a 25 mg dose did not cause any serious side effects. Another study found that therapy with psilocybin also did not lead to serious side effects in participants. These findings suggest that psilocybin can be safely used with therapy. However, it's important to remember that these conclusions are based on past studies, and individual experiences may vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PTSD?

Unlike the standard treatments for PTSD, which often include antidepressants and therapy, psilocybin-assisted therapy uses psilocybin, a psychedelic compound found in certain mushrooms. This treatment is unique because it targets the brain in a novel way by promoting neuroplasticity, potentially allowing for deeper emotional processing and healing. Researchers are excited about psilocybin because it may offer rapid and long-lasting relief from PTSD symptoms, providing hope for those who haven't responded well to traditional therapies.

What evidence suggests that psilocybin might be an effective treatment for PTSD?

Research has shown that therapy using psilocybin, a compound found in certain mushrooms, may help treat PTSD (Post-Traumatic Stress Disorder). Studies have found that just one dose of psilocybin, when combined with therapy, can lessen PTSD symptoms. Early results suggest this method might be particularly effective for individuals not helped by other treatments. Psilocybin also improves mood and reduces negative feelings, which are common in PTSD. These findings suggest that psilocybin could be a useful option for managing PTSD symptoms. ^{3 6 7 8 9}

Who Is on the Research Team?

Manish Agrawal, MD, MSC

Principal Investigator

Sunstone Medical, PC

Are You a Good Fit for This Trial?

This trial is for cisgender women over 18 with PTSD from sexual assault. They must be able to swallow pills, have a negative pregnancy test if applicable, and agree to lifestyle changes and study procedures. Exclusions include serious risks to others, certain psychiatric disorders or treatments, uncontrolled health conditions, drug abuse, and men.

Inclusion Criteria

I am a cisgender woman aged 18 or older.

Meet DSM-5 criteria for current PTSD secondary to sexual assault

CAPS-5 score of 25 or higher at Baseline

Exclusion Criteria

Would present a serious risk to others

History of or current primary psychotic disorders, major depressive disorder with psychotic features, bipolar affective disorder type 1, or personality disorders

I have not had electroconvulsive therapy in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 25 mg dose of oral psilocybin in conjunction with therapy

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The study tests the effects of a single oral dose of 25 mg psilocybin combined with therapy on PTSD symptoms in women who've experienced sexual assault. It's an open-label Phase 2 trial where all participants know they're receiving the psilocybin treatment.

How Is the Trial Designed?

Group I: Psilocybin-Assisted Therapy Experimental Treatment 1 Intervention

This is a Phase 2, single-center, fixed dose, open-label study to explore the efficacy, safety, and tolerability of a 25 mg dose of oral psilocybin with therapy in adult cisgender women participants with PTSD secondary to an index trauma of sexual assault. There is no comparator group.

Who Is Running the Clinical Trial?

Sunstone Medical

Lead Sponsor

Trials

3

Recruited

110+

Published Research Related to This Trial

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]

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 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]

Citations

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

The Psychedelic Future of Post-Traumatic Stress Disorder ... While data thus far suggest that psychedelic-assisted psychotherapy (PAP) has the potential to be a successful treatment for PTSD, several features of these ...

2. 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 ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05876481

Evaluation of Psilocybin-assisted Psychotherapy (PaP) for ... PaP may similarly benefit the treatment of posttraumatic stress disorder (PTSD). Research indicates high treatment drop-out rates (approximately 30%) among PTSD ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178124001719

Efficacy and safety of psychedelics for the treatment ... Our analyses suggest that psychedelics reduce negative mood, and have potential efficacy in other mental disorders, such as substance-use disorders and PTSD.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40883964/

A nonrandomized open-label clinical trial Conclusions: Psilocybin at a dose of 25 mg, administered with psychological support, may be safe, well-tolerated and associated with symptomatic ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05562973?cond=Post%20Traumatic%20Stress%20Disorder&intr=%22Psilocybin%22&viewType=Table&rank=2

Safety and Tolerability of Psilocybin in Post-Traumatic ... The purpose of this study is to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce post-traumatic stress ...

8. bmjopen.bmj.com bmjopen.bmj.com/content/13/5/e068884

Study protocol of an open-label proof-of-concept trial ... PAT will be safe to administer among USMV with PTSD as indicated by no serious AE reporting related to the administration of psilocybin. A descriptive analysis ...

9. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/02698811251362390

A nonrandomized open-label clinical trial Conclusions: Psilocybin at a dose of 25 mg, administered with psychological support, may be safe, well-tolerated and associated with symptomatic ...