State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma (STARLIGHT)
Open-label, single-group Phase II trial (n=15) of psilocybin-assisted therapy in US military veterans with PTSD: two oral psilocybin sessions (15 mg then 25 mg) plus preparatory and integration psychotherapy.
Detailed Description
Open-label, single-group Phase II treatment study testing psilocybin-assisted therapy for PTSD in US military veterans; target N=15 with two dosing sessions (15 mg then 25 mg) combined with psychotherapy.
Participants complete a 5-week participation phase including three preparatory sessions, two dosing days approximately two weeks apart, and four integration sessions; safety, tolerability, and clinical efficacy (CAPS-5) are primary aims.
Key eligibility: US military veterans with DSM-5 PTSD and CAPS-5 ≥23; exclusions include psychotic/bipolar disorders, significant cardiovascular disease, recent hallucinogen use, and acute suicide risk.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
Psilocybin-assisted therapy
experimentalSingle-group psilocybin-assisted therapy including 3 preparatory sessions, 2 dosing days (15 mg then 25 mg ~2 weeks apart), and 4 integration sessions over ~5 weeks.
Interventions
- Psilocybin15 mgvia Oral• single dose• 1 doses total
Low-dose first session to assess tolerability and familiarise participants
- Psilocybin25 mgvia Oral• single dose• 1 doses total
High-dose second session ~2 weeks after first
Participants
Inclusion Criteria
- Inclusion Criteria:
- 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 allowable if on a stable regimen for 3 months
- Concurrent psychotherapy allowed if type/frequency stable for ≥2 months prior to screening and expected to remain stable during study
- Medically stable as determined by interview, medical questionnaire, physical exam, ECG, and routine labs
- No use of hallucinogens in the past 3 months and no history of regular or frequent use of hallucinogens
Exclusion Criteria
- Exclusion Criteria:
- Pregnancy or nursing; individuals of child-bearing potential not using highly effective contraception; partners of child-bearing potential not using highly effective contraception
- Cardiovascular: coronary artery disease, stroke, angina, uncontrolled hypertension, clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged QTc (> 450 msec), artificial heart valve, or TIA in past year; SBP >139 mm Hg; DBP >89 mm Hg; HR >90 bpm
- Epilepsy with history of seizures
- Insulin-dependent diabetes; if taking oral hypoglycemic agent, no history of symptomatic hypoglycaemia
- Current or past DSM-5 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 moderate or severe alcohol, tobacco, caffeine, or other drug use disorder; regular smokers must agree to use a nicotine patch on dosing days
- 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)
- Psychiatric conditions precluding therapeutic rapport (long-term unstable relationships, significant stress-related paranoia, identity disturbances)
- History of a medically significant suicide attempt
- Current MAOI antidepressant use
Study Details
- StatusRecruiting
- PhasePhase II
- Typeinterventional
- DesignNon-randomized
- Target Enrollment15 participants
- TimelineStart: 2025-01-30End: 2025-08-31
- Compounds
- Topic