A Phase 2, Open Label Study of the Safety and Effectiveness of MDMA-assisted Therapy for Participants With Posttraumatic Stress Disorder
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Change from Baseline in PTSD Checklist (adapted PCL-5) total score
研究概览
简要总结
The purpose of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with PTSD.
The main question it aims to answer is: Do two open-label sessions of MDMA-assisted therapy reduce PTSD symptoms?
Participants will undergo three non-drug preparatory therapy sessions followed by two open-label MDMA-assisted therapy sessions. After, participants will undergo three non-drug integrative therapy sessions.
详细描述
This Phase 2, open-label study will provide supportive data on the safety and effectiveness of MDMA-assisted therapy in participants with PTSD. This study will be conducted at a single study site in Vancouver, BC. There will be at least 2 co-therapy pairs. The study will enroll up to 20 participants.
The Preparatory Period will consist of three 90-minute non-drug preparatory therapy sessions. A flexible divided dose of MDMA will be administered during the Treatment Period with manualized therapy in up to two open-label experimental sessions. During the Treatment Period, each experimental session is followed by three 90-minute non-drug integrative therapy sessions. The experimental sessions are scheduled roughly 3 to 5 weeks apart.
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 fluent in speaking and reading a recognized language of the study site.
- •Are able to swallow pills.
- •Agree to have study visits recorded, including Study Drug Sessions and non-drug therapy sessions.
- •Must provide a contact (relative, spouse, close friend, or other support person) 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 of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
- •Must not participate in any other interventional clinical trials during the duration of the study, and commit to medication dosing, therapy, and study procedures.
- •At baseline, have moderate PTSD diagnosis.
排除标准
- •Are not able to give adequate informed consent.
- •Have uncontrolled hypertension.
- •Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] in males and>460 ms in females corrected by Friderica's formula).
- •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 disease.
- •Have history of hyponatremia or hyperthermia.
- •Weigh less than 48 kilograms (kg).
- •Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control.
- •Have current alcohol or substance use disorders.
研究组 & 干预措施
MDMA-assisted therapy
Two sessions of MDMA-assisted therapy with an initial dose of 80 mg or 120 mg midomafetamine HCl and optional supplemental dose of 40 mg 1.5 to 2 hours later
干预措施: midomafetamine (Drug)
MDMA-assisted therapy
Two sessions of MDMA-assisted therapy with an initial dose of 80 mg or 120 mg midomafetamine HCl and optional supplemental dose of 40 mg 1.5 to 2 hours later
干预措施: Therapy (Behavioral)
结局指标
主要结局
Change from Baseline in PTSD Checklist (adapted PCL-5) total score
时间窗: 18 weeks post baseline post enrollment confirmation
20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms, derived from the symptoms of PTSD per DSM-5. The gold standard for diagnosing PTSD is a structured clinical interview such as the Clinician-Administered PTSD Scale (CAPS-5). When necessary, the PCL-5 can be scored to provide a provisional PTSD diagnosis.The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the DSM-IV version. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely."
次要结局
未报告次要终点