35 Participants Needed

Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder

(SUN004 Trial)

JV
CL
Overseen ByCelia Leeks
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Sunstone Medical
Must be taking: SSRIs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The proposed Phase 2, single-center, fixed dose, open-label study will explore the efficacy, safety, and tolerability of 25 mg dose of oral psilocybin in conjunction with therapy in cisgender women participants diagnosed with PTSD secondary to an index trauma of sexual assault.

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 psilocybin-assisted therapy generally safe for humans?

Psilocybin-assisted therapy appears to be generally safe when administered under supervision, with most side effects being mild and temporary. However, there are rare cases of severe adverse events, such as increased suicidal thoughts, and some individuals may experience challenging psychological experiences, especially without proper support.12345

How is psilocybin-assisted therapy different from other PTSD treatments?

Psilocybin-assisted therapy is unique because it involves the use of a psychedelic compound, psilocybin, which is administered in controlled doses under medical supervision to help patients confront traumatic memories and reduce emotional avoidance. Unlike traditional PTSD treatments, which often have limited efficacy and are difficult to tolerate, psilocybin may promote neuroplasticity (the brain's ability to change and adapt) and has shown promise in producing long-term improvements after just one or a few sessions.12678

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

Research suggests that psilocybin-assisted therapy may help reduce PTSD symptoms by decreasing emotional avoidance and increasing acceptance and self-compassion. Although no studies have directly tested psilocybin for PTSD, it has shown promise in treating related conditions like depression and anxiety, and early evidence indicates it may help with PTSD symptoms in combat veterans.12679

Who Is on the Research Team?

MA

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
See 11 more

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.
See 16 more

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?
1Treatment groups
Experimental Treatment
Group I: Psilocybin-Assisted TherapyExperimental Treatment1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sunstone Medical

Lead Sponsor

Trials
3
Recruited
110+

Published Research Related to This Trial

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

Citations

Psilocybin for Trauma-Related Disorders. [2022]
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]
[Psilocybin-Assisted Treatment of Depression, Anxiety and Substance use Disorders: Neurobiological Basis and Clinical Application]. [2023]
Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. [2022]
Psilocybin facilitates fear extinction in mice by promoting hippocampal neuroplasticity. [2023]
Psilocybin-Assisted Therapy: A Review of a Novel Treatment for Psychiatric Disorders. [2018]
Psilocybin history, action and reaction: A narrative clinical review. [2023]
Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. [2018]
[Treatment with psilocybin: applications for patients with psychiatric disorders]. [2021]
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