Psilocybin for Post-Traumatic Stress Disorder

(STARLIGHT Trial)

Overseen By Lynnette A. Averill, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Baylor College of Medicine

Must be taking: Ssris

Must not be taking: Maoi antidepressants

Disqualifiers: Schizophrenia, Bipolar, Cardiovascular, 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: 5 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether psilocybin, a compound found in certain mushrooms, can help treat PTSD in U.S. Veterans. Participants will undergo psilocybin-assisted therapy, which includes two sessions of psilocybin combined with talk therapy over five weeks. The goal is to determine if this approach is safe and effective in reducing PTSD symptoms. Veterans with PTSD who haven't recently used hallucinogens and are stable on any current medications or therapy might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial allows participants to continue taking SSRIs (a type of antidepressant) if they have been on a stable dose for at least 3 months. However, if you are currently using MAOI antidepressants, you will need to stop taking them to participate in the trial.

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, may be safe and manageable. In one study, a 25 mg dose of psilocybin did not cause any serious side effects, and no participants withdrew due to negative reactions. Another study found that psilocybin was well-tolerated and did not cause major issues. These findings suggest that psilocybin could be safe for individuals with PTSD. As with any treatment, discussing potential risks and benefits with healthcare providers is important. ^{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 involve medications like SSRIs and therapy, psilocybin offers a unique approach by leveraging its psychedelic properties to potentially foster deep psychological insights and emotional release. Researchers are excited about psilocybin because it acts on serotonin receptors in the brain, which may help in processing traumatic experiences differently and more effectively. This treatment has the potential to provide rapid and lasting relief after just a few sessions, unlike conventional methods that can take weeks or months to show results.

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

Research has shown that psilocybin therapy, which participants in this trial will receive, might help reduce PTSD symptoms. Early data indicates that a single dose of psilocybin, when combined with therapy, can lessen PTSD symptoms in some individuals. Studies suggest that psilocybin can alter perception and enhance mood, potentially benefiting those with PTSD. Initial findings also suggest that psilocybin might encourage patients to continue their treatment, as many with PTSD tend to stop therapy early. This growing evidence supports psilocybin as a promising option for treating PTSD. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for US Military Veterans with PTSD who have a high school education or equivalent, are on stable SSRIs if applicable, and haven't used hallucinogens recently. They must be medically stable without severe substance use disorders, no major psychiatric conditions like schizophrenia or bipolar disorder, not at risk of suicide, and agree to contraception if needed.

Inclusion Criteria

Be a United States Military Veteran

Have at least a high-school level of education or equivalent (e.g. GED)

I have been on a stable dose of SSRIs for at least 3 months.

Exclusion Criteria

I have epilepsy with a history of seizures.

I haven't had a severe addiction to substances like alcohol or drugs in the past 6 months.

History of a medically significant suicide attempt

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 5-week participation phase including 3 preparatory sessions, 2 psilocybin dosing days, and 4 integration sessions

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview

The study tests the safety and effectiveness of psilocybin-assisted therapy in treating PTSD. Participants will undergo two sessions of guided psilocybin therapy (at doses of 25mg or 15mg) combined with psychotherapy to see how well it helps them recover from trauma.

How Is the Trial Designed?

Group I: Psilocybin-assisted therapy Experimental Treatment 2 Interventions

Participants will enter a 5-week participation phase, which includes 3 preparatory sessions, 2 dosing days, and 4 integration sessions.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

AIM Youth Mental Health

Collaborator

Trials

2

Recruited

70+

Texas Department of State Health Services

Collaborator

Trials

5

Recruited

5,300+

Usona Institute

Collaborator

Trials

18

Recruited

1,100+

Published Research Related to This Trial

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 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]

Citations

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Psychedelic-Assisted Therapy for PTSD

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

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Preliminary evidence supports the potential therapeutic action of psilocybin to alleviate PTSD symptoms. This open-label pilot study aims to ...

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

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A nonrandomized open-label clinical trial

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

8.

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COMP360 psilocybin at a dose of 25 mg was not associated with any serious adverse events or adverse events resulting in study withdrawal in ...

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News Details

Open-label Phase 2 study shows a single 25 mg COMP360 psilocybin dose was well tolerated, with no serious adverse events observed, ...