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

Trial Summary

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.

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

Research suggests that psilocybin, a psychedelic drug, may help reduce PTSD symptoms by promoting positive psychological changes and helping people confront traumatic memories. Although it hasn't been specifically tested for PTSD, studies show it can improve mood and anxiety in other conditions, and early evidence indicates it might help combat veterans with PTSD. ^{1 2 3 4 5}

Is psilocybin safe for humans?

Psilocybin is generally considered safe when given in a controlled setting with proper support, although some people may experience challenging psychological effects. In a survey, a small percentage of people reported risky behavior or needed medical help after taking psilocybin, but most participants found the experience beneficial. ^{1 4 5 6 7}

How is the drug psilocybin different from other PTSD treatments?

Psilocybin is unique because it is a psychedelic drug that may help with PTSD by promoting neuroplasticity (the brain's ability to change and adapt) and facilitating fear extinction, which is important for overcoming traumatic memories. Unlike traditional treatments, psilocybin is used in combination with psychotherapy and is being explored as a novel approach due to its potential to address symptoms that other treatments struggle with. ^{1 4 5 8 9}

What is the purpose of this trial?

The principal investigator for this study plans to build upon the psilocybin-assisted therapy intervention used in prior completed trials to conduct an open-label trial of two psilocybin administration sessions combined with psychotherapy to investigate the safety, tolerability, and clinical efficacy of psilocybin-assisted therapy for the treatment of PTSD in US Veterans.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. 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]

2. Germany pubmed.ncbi.nlm.nih.gov

[Psilocybin-Assisted Treatment of Depression, Anxiety and Substance use Disorders: Neurobiological Basis and Clinical Application]. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

4. Germany pubmed.ncbi.nlm.nih.gov

Psilocybin for Trauma-Related Disorders. [2022]

5. China pubmed.ncbi.nlm.nih.gov

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

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

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

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

Optimal dosing for psilocybin pharmacotherapy: Considering weight-adjusted and fixed dosing approaches. [2022]

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

Efficacy of Psychoactive Drugs for the Treatment of Posttraumatic Stress Disorder: A Systematic Review of MDMA, Ketamine, LSD and Psilocybin. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Reviewing the Potential of Psychedelics for the Treatment of PTSD. [2021]