The STARLIGHT Protocol: State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety of psilocybin-assisted therapy for PTSD
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Psilocybin-assisted therapy
Participants will enter a 5-week participation phase, which includes 3 preparatory sessions, 2 dosing days, and 4 integration sessions.
干预措施: Psilocybin 15mg (Drug)
Psilocybin-assisted therapy
Participants will enter a 5-week participation phase, which includes 3 preparatory sessions, 2 dosing days, and 4 integration sessions.
干预措施: Psilocybin 25mg (Drug)
结局指标
主要结局
Safety of psilocybin-assisted therapy for PTSD
时间窗: 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
时间窗: 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.
次要结局
- Self-reported clinical efficacy of psilocybin-assisted therapy for PTSD symptoms(Baseline to 6-month follow up)
- Self-reported clinical efficacy of psilocybin-assisted therapy for depressive symptoms(Baseline to 6-month follow up)
- Self-reported clinical efficacy of psilocybin-assisted therapy for anxiety symptoms(Baseline to 6-month follow up)
研究者
Lynnette Astrid Averill
Associate Professor
Baylor College of Medicine