Examining the Safety and Clinical Efficacy of Psilocybin Therapy for Veterans With PTSD: An Open-Label Proof-of-Concept Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Type, severity, and frequency of Adverse Events (AEs) associated with psilocybin assisted therapy
研究概览
简要总结
The primary aim of this study is to assess the safety and efficacy of psilocybin-assisted therapy in the treatment of post-traumatic stress disorder in United States military Veterans.
详细描述
The objective of this study is to determine the safety and efficacy of psilocybin assisted psychotherapy in the treatment of Veterans with PTSD.
This study will recruit 15 United States Military Veterans, age 21 to 64, primarily from the Columbus and Central Ohio Region who meet the criteria for PTSD. After enrollment and informed consent, participants will receive two separate doses of psilocybin in conjunction with preparatory and post-psilocybin therapy sessions. Each psilocybin session will last approximately 8 hours and will be facilitated by two trained session facilitators. Before the first psilocybin session, participants will meet with one or both of the session facilitators for a total of 6-8 hours of contact time (or up to 4 meetings) before the first psilocybin session day. Two post psilocybin therapy session visits will follow Psilocybin Sessions 1 and 2. Psilocybin Sessions 1 and 2 will occur about two weeks apart. Follow-up visits will occur 1 and 2 weeks and 1, 3, and 6 months after the final psilocybin session, with additional contact hours scheduled as needed. Thus, the intervention and follow-up requires at least 13 visits over a period of about 8-10 months.
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
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •A US military Veteran
- •21 to 64 years old
- •Have at least a high-school level of education or equivalent.
- •Have a current DSM-5 diagnosis of Post-Traumatic Stress Disorder
- •Have a CAPS-5 total severity score of ≥35 at baseline
- •No antidepressant medications prior to enrollment
- •Be judged by study team clinicians to be at low risk for suicidality
- •Be medically stable
- •Have limited lifetime use of hallucinogens
- •General medical
排除标准
- •Women who are pregnant
- •Cardiovascular conditions
- •Epilepsy with history of seizures
- •Insulin-dependent diabetes
- •Currently taking psychoactive prescription medication
- •Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting serotonergic effect, including Monoamine oxidase inhibitors..
- •Psychiatric Exclusion Criteria:
- •Current or past history of schizophrenia or other psychotic disorders or Bipolar I or II Disorder
- •Current or history within one year of a moderate or severe alcohol, tobacco, or other drug use disorder
- •Have a first or second-degree relative with schizophrenia spectrum or other psychotic disorders or Bipolar I or II Disorder
- •Has a psychiatric condition which precludes the establishment of therapeutic rapport
- •History of a medically significant suicide attempt
- •Current antidepressant use
研究组 & 干预措施
Psilocybin-assisted therapy
Participants will receive two doses of psilocybin, approximately 2 weeks apart, in conjunction with preparatory and post-psilocybin therapy sessions
干预措施: Psilocybin (Drug)
结局指标
主要结局
Type, severity, and frequency of Adverse Events (AEs) associated with psilocybin assisted therapy
时间窗: Baseline to Primary Endpoint (1 month post psilocybin session 2)
The primary clinician/session facilitator for each participant will identify/record adverse effects (i.e. the emergence of any untoward physical or psychological events or symptoms) and safety concerns at each study visit. The type, severity, and frequency of adverse events will be collected in order to identify and characterize any safety concerns that may arise. Relationship to study drug will also be reported
Columbia Suicide Severity Rating Scale (C-SSRS)
时间窗: Baseline to Primary Endpoint (1 month post psilocybin session 2)
The C-SSRS is divided into four subscales based on 1) severity of ideation 2) intensity of ideation 3) suicidal behavior, and 4) lethality of attempt. Severity of ideation scores will be assessed for significant changes from baseline to primary endpoint. Proportion of participants meeting criteria for low, medium, and high risk will be reported.
次要结局
- PTSD Symptom Severity as measured by the Clinician Administered PTSD Scale-5 (CAPS-5)(Baseline to Primary Endpoint (1 month post psilocybin session 2))
- PTSD Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5)(Baseline to Primary Endpoint (1 month post psilocybin session 2))
研究者
Alan K. Davis
Assistant Professor
Ohio State University