An Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder in Veterans
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Change in CAPS-5 Total Severity Score
研究概览
简要总结
The goal of this clinical trial is to learn if MDMA-assisted group therapy is safe and effective in in people with at least moderate PTSD.
The main question it aims to answer is: Do two sessions of open-label MDMA-assisted group therapy reduce PTSD symptoms?
Participants will undergo non-drug preparatory therapy sessions before their MDMA-assisted therapy sessions. After, they will undergo non-drug integrative therapy sessions.
详细描述
To further assess the feasibility and safety of MDMA-assisted group therapy for participants with at least moderate PTSD, the sponsor is conducting a Phase 2, open-label, non-randomized, 3-cohort study. This novel treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA (120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later), along with non-drug preparatory and integrative therapy administered in both individual and group sessions.
The Primary Outcome measure, the Clinician Administered PTSD Scale (CAPS-5), evaluates changes in PTSD symptom severity and is assessed by a blinded centralized Independent Rater (IR) pool. The therapeutic approach will combine manualized MDMA-assisted therapy for PTSD with group therapy components.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are at least 18 years old.
- •Are a U.S. Military Veteran
- •Are fluent in speaking and reading the predominantly used or recognized language of the study site.
- •Are able to swallow pills.
- •Agree to have study visits recorded, including Experimental Sessions, outcome assessments, and non-drug psychotherapy sessions.
- •Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
- •Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
- •If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraception through 10 days after the last Experimental Session.
- •Must not participate in any other interventional clinical trials during the duration of the study.
- •Have a current PTSD diagnosis at the time of screening.
排除标准
- •Are not able to give adequate informed consent.
- •Have uncontrolled hypertension.
- •Have a marked baseline QTcF interval >450 milliseconds [ms] demonstrated on repeated ECG assessments.
- •Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- •Have evidence or history of significant medical disorders.
- •Have symptomatic liver or biliary disease.
- •Have history of hyponatremia or hyperthermia.
- •Weigh less than 48 kilograms (kg).
- •Are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control.
- •Have an active illicit drug or prescription drug substance use disorder
研究组 & 干预措施
Two Sessions of MDMA-assisted therapy
Two MDMA-assisted Therapy Sessions with 120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later
干预措施: Midomafetamine (Drug)
Two Sessions of MDMA-assisted therapy
Two MDMA-assisted Therapy Sessions with 120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later
干预措施: Therapy (Behavioral)
结局指标
主要结局
Change in CAPS-5 Total Severity Score
时间窗: Baseline - 3 months from first Experimental Session
The CAPS-5 is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure \[114\], including the most distressing event, time since exposure, to produce a diagnostic score (presence vs. absence) and a PTSD Total Severity score \[114\]. The CAPS-5 rates intrusion symptoms (intrusive thoughts or memories), avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress and dissociation. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
次要结局
- Change in Sheehan Disability Scale (SDS)(Baseline - 3 months from First Experimental Session)