PTSDPhase 2STARLIGHTNCT06888128
State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma
A Phase 2 study testing Psilocybin 15mg and Psilocybin 25mg in people with PTSD, run by Baylor College of Medicine at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- PTSD
- What is being tested?
- Psilocybin 15mg and Psilocybin 25mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2025to 15 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be a United States Military Veteran
- Have at least a high-school level of education or equivalent (e.g. GED).
- Have a current DSM-5 diagnosis of Post-traumatic Stress Disorder
- Have a CAPS-5 total severity score of ≥23 at baseline
- SSRIs will be allowable so long as participants are on a stable regimen for a period of 3 months.
- Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least 2 months prior to screening and is expected to remain stable during participation in the study.
- Be medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
- No use of hallucinogens in the past 3 months and no history of regular or frequent use of hallucinogens
Who cannot join
- General medical exclusion criteria:
- 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
- Individuals with partners of childbearing potential who are sexually active and not practicing a highly effective means of contraception
- Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrilation), prolonged QTc interval (i.e., QTc > 450 msec), artificial heart valve, or TIA in the past year • Systolic blood pressure (SBP) > 139 mm HG; diastolic blood pressure (DBP) > 89 mm HG; heart rate (HR) > 90 bpm.
- Epilepsy with history of seizures
- Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of symptoms of hypoglycemia
Show all 14Show fewer
- Psychiatric Exclusion Criteria:
- Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder
- Current or history within six months of meeting DSM-5 criteria for a moderate or severe alcohol, tobacco, caffeine, or other drug use disorder; if a regular smoker, they must agree to use a nicotine patch on the day of dosing as smoking will not be allowed on these sessions
- Have a first degree relative with schizophrenia spectrum or other psychotic disorders including substance/medication-induced or due to another medical condition
- Risk for acute suicidality as determined by clinician judgment (C-SSRS)
- Has a psychiatric condition which precludes the establishment of therapeutic rapport as evidenced by long-term patterns of unstable relationships, history of significant stress-related paranoia, and identity disturbances
- History of a medically significant suicide attempt
- Current MAOI antidepressant use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Marika Del Motte, M.Sc., 713-798-3212, marika.delmotte@bcm.edu
Lynnette A. Averill, Ph.D.
About this study
Official title: The STARLIGHT Protocol: State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma
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.
- Conditions
- PTSD
- Being tested
- Psilocybin 15mg, Psilocybin 25mg
- Keywords
- PTSD, veterans, psilocybin, trauma, psychedelic
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin 15mgDrug
Each participant will have a low dose (15 mg) psilocybin session to establish basic skills with session format, psilocybin effects, and continue to build rapport with session facilitators. Given the potential intensity of the psilocybin and the reality of experiencing significant trauma memories, the purpose of the first psilocybin session is to familiarize participants with the drug effects that may be encountered at a higher dose of psilocybin. The first psilocybin session will also allow for assessment of both the suitability of each participant to the study procedures and drug effects, and the safety of administering a higher dose to each participant.
Psilocybin 25mgDrug
The second psilocybin session will utilize a high dose (25mg) and take place approximately 2 weeks after the first psilocybin session.
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin-assisted therapy | Experimental | Participants will enter a 5-week participation phase, which includes 3 preparatory sessions, 2 dosing days, and 4 integration sessions. Receives: Drug: Psilocybin 15mg; Drug: Psilocybin 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of psilocybin-assisted therapy for PTSD
Safety as measured by Adverse Event Reporting
Measured: Baseline to 6-month follow up
Safety of psilocybin-assisted therapy for PTSD
Safety as measured by changes in suicidal ideation on the Columbia Suicide Safety Rating Scale (CSSRS). This section of the measure is assessed on a scale of 0 to 25, with higher scores indicating greater intensity of suicidal ideation.
Measured: Baseline to 6-month follow up
Efficacy of psilocybin-assisted therapy for PTSD
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score. This measure is assessed on a scale of 0 to 80, with higher scores reflecting increased severity of PTSD symptoms.
Measured: Baseline to 6-month follow up
Secondary outcomes (3)
Self-reported clinical efficacy of psilocybin-assisted therapy for PTSD symptoms
Change in self-reported PTSD Checklist 5 (PCL-5) scores. This measure is assessed on a scale of 0 to 80, with higher scores reflecting increased severity of PTSD symptoms.
Measured: Baseline to 6-month follow up
Self-reported clinical efficacy of psilocybin-assisted therapy for depressive symptoms
Changes in self-reported Quick Inventory of Depression Severity (QIDS) scores. This measure is assessed on a scale of 0 to 27, with higher scores reflecting increased severity of depressive symptoms.
Measured: Baseline to 6-month follow up
Self-reported clinical efficacy of psilocybin-assisted therapy for anxiety symptoms
Changes in self-reported Generalized Anxiety Disorder-7 (GAD-7) scores. This measure is assessed on a scale of 0 to 21, with higher scores reflecting increased severity of anxiety symptoms.
Measured: Baseline to 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start30 Jan 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Department of State Health Services, Usona Institute, AIM Youth Mental Health
- Responsible party
- Principal investigator, Lynnette Astrid Averill, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888128
- Sponsor's protocol ID
- H-50300
- Acronym
- STARLIGHT
- Status last verified
- Jan 2026
- First submitted
- 21 Feb 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STARLIGHT Protocol: State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma
- ClinicalTrials.gov ID
- NCT06888128
- Acronym / sponsor ID
- STARLIGHT / H-50300
- Conditions
- PTSD
- Keywords
- PTSD, veterans, psilocybin, trauma, psychedelic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Texas Department of State Health Services, Usona Institute, AIM Youth Mental Health
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psilocybin-assisted therapy | Experimental | Drug: Psilocybin 15mg, Drug: Psilocybin 25mgParticipants will enter a 5-week participation phase, which includes 3 preparatory sessions, 2 dosing days, and 4 integration sessions. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Be a United States Military Veteran
- Have at least a high-school level of education or equivalent (e.g. GED).
- Have a current DSM-5 diagnosis of Post-traumatic Stress Disorder
- Have a CAPS-5 total severity score of ≥23 at baseline
- SSRIs will be allowable so long as participants are on a stable regimen for a period of 3 months.
Key exclusion criteria (14 listed)
- General medical exclusion criteria:
- Psychiatric Exclusion Criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin 15mgEach participant will have a low dose (15 mg) psilocybin session to establish basic skills with session format, psilocybin effects, and continue to build rapport with session facilitators. Given the potential intensity of the psilocybin and the reality of experiencing significant trauma memories, the purpose of the first psilocybin session is to familiarize participants with the drug effects that may be encountered at a higher dose of psilocybin. The first psilocybin session will also allow for assessment of both the suitability of each participant to the study procedures and drug effects, and the safety of administering a higher dose to each participant. | Drug | Psilocybin-assisted therapy |
| Psilocybin 25mgThe second psilocybin session will utilize a high dose (25mg) and take place approximately 2 weeks after the first psilocybin session. | Drug | Psilocybin-assisted therapy |
Primary outcome
Safety of psilocybin-assisted therapy for PTSD
Time frame: Baseline to 6-month follow up
Safety as measured by Adverse Event Reporting
Safety of psilocybin-assisted therapy for PTSD
Time frame: Baseline to 6-month follow up
Safety as measured by changes in suicidal ideation on the Columbia Suicide Safety Rating Scale (CSSRS). This section of the measure is assessed on a scale of 0 to 25, with higher scores indicating greater intensity of suicidal ideation.
Efficacy of psilocybin-assisted therapy for PTSD
Time frame: Baseline to 6-month follow up
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score. This measure is assessed on a scale of 0 to 80, with higher scores reflecting increased severity of PTSD symptoms.
3 secondary outcomes
Self-reported clinical efficacy of psilocybin-assisted therapy for PTSD symptoms
Time frame: Baseline to 6-month follow up
Self-reported clinical efficacy of psilocybin-assisted therapy for depressive symptoms
Time frame: Baseline to 6-month follow up
Self-reported clinical efficacy of psilocybin-assisted therapy for anxiety symptoms
Time frame: Baseline to 6-month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin 15mg and Psilocybin 25mg in people with PTSD, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lynnette A. Averill, Ph.D. ((832) 271-6615, emerging@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of psilocybin-assisted therapy for PTSD (time frame: Baseline to 6-month follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.