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Psychedelic Therapy

Psilocybin for Post-Traumatic Stress Disorder (STARLIGHT Trial)

Houston, TX
Phase 2
Recruiting
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a current DSM-5 diagnosis of Post-traumatic Stress Disorder
Be between 18 and 65 years old
Must not have
Individuals who are pregnant or nursing; individuals who are of child-bearing potential and sexually active who are not practicing a highly effective means of birth control
Epilepsy with history of seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6-month follow up
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if using psilocybin (a compound found in certain mushrooms) along with therapy can help treat PTSD in US veterans. The study will involve two sessions of psilocybin

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Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Psilocybin can cause various side effects including changes in sensory perception, altered sense of time, mood swings ranging from euphoria to distress, nausea, headache, increased heart rate and blood pressure. Long-term psychological effects are possible but rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with PTSD.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.
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I have epilepsy with a history of seizures.
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I am currently taking an MAOI antidepressant.
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I don't have serious heart conditions or uncontrolled high blood pressure.
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I use insulin for my diabetes and haven't had low blood sugar symptoms if on pills.
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A close family member has schizophrenia or a similar condition.
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I have a long-term psychiatric condition that affects my relationships and perception.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6-month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6-month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy of psilocybin-assisted therapy for PTSD
Safety of psilocybin-assisted therapy for PTSD
Secondary study objectives
Self-reported clinical efficacy of psilocybin-assisted therapy for PTSD symptoms
Self-reported clinical efficacy of psilocybin-assisted therapy for anxiety symptoms
Self-reported clinical efficacy of psilocybin-assisted therapy for depressive symptoms
Other study objectives
Changes in Resting-State Functional Connectivity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Psilocybin-assisted therapyExperimental Treatment2 Interventions
Participants will enter a 5-week participation phase, which includes 3 preparatory sessions, 2 dosing days, and 4 integration sessions.

Find a Location

Closest Location:Baylor College of Medicine· Houston, TX

Who is running the clinical trial?

AIM Youth Mental HealthUNKNOWN
1 Previous Clinical Trials
54 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,042 Previous Clinical Trials
6,030,923 Total Patients Enrolled
Texas Department of State Health ServicesOTHER
4 Previous Clinical Trials
5,328 Total Patients Enrolled
Usona InstituteOTHER
17 Previous Clinical Trials
1,067 Total Patients Enrolled
~10 spots leftby Aug 2025
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