A Phase 2, Open-Label Study Investigating the Safety and Efficacy of MDMA-Assisted Therapy for Veterans With Posttraumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans who are at least 18 years old
- •Are able to swallow pills
- •Are able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
- •Proficient in speaking and reading English.
排除标准
- •Condition impairing oral intake or digestive absorption.
- •Unable to give adequate informed consent.
- •Significant suicide risk as defined by suicidal ideation with intend and plan as endorsed on items 5 on C-SSRS within the past 3 months
- •Cardiovascular disease, including, but not limited to, coronary artery disease (CAD) and chronic heart failure (CHF)
- •A history of, or a current primary schizophrenia, schizoaffective disorder or any form of psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1, or personality disorders.
- •Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control if sexually active with a biologically male partner.
- •Current enrollment in any investigational drug or device study or participation in such within 30 days of screening.
研究组 & 干预措施
Group
干预措施: MDMA (Drug)
Individual
干预措施: MDMA (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 15 months
To assess the safety and tolerability of individual and group MDMA-assisted therapy in adult veterans with PTSD using Incidence and occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) from signing of ICF until the EOS Visit.
C-SSRS
时间窗: 15 months
Incidence of changes in suicidal ideation/behavior (measured using the Columbia-Suicide Severity Rating Scale \[C-SSRS\]) score at all visits from Baseline to EOS Visit.
次要结局
- Efficacy of Therapy(15 months)
- Effect of Therapy(15 months)
- Effects of Therapy(15 months)