A Randomized, Double-Blind, Single-Site Phase II 2-Arm Study to Compare the Safety and Preliminary Efficacy of Manualized MDMA-Assisted Therapy to Low Dose D-Amphetamine Assisted Therapy in Veterans For The Treatment of Moderate to Severe PTSD
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Compare changes in PTSD symptom severity in the MDMA vs active control group.
研究概览
简要总结
This randomized, double-blind, single-site phase II 2-arm study will investigate the safety and preliminary efficacy of MDMA-assisted therapy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in participants aged 18 years and older with PTSD of at least moderate severity.
详细描述
This randomized, double-blind, single-site phase II 2-arm study will compare MDMA-assisted therapy with low dose d-amphetamine-assisted therapy to treat PTSD symptoms in veteran participants aged 18 years and older with PTSD of at least moderate severity, as measured by the change in CAPS-5 total severity score. The study will be conducted in up to N=40 participants from the Greater Los Angeles VA randomized with a 1:1 allocation to Group 1: MDMA-assisted therapy or Group 2: low dose d-amphetamine assisted therapy.
For each participant, the study will consist of:
- Screening Period: phone screen, informed consent, eligibility assessment, Screening CAPS-5, and Initial Enrollment of eligible participants.
- Preparatory Period: medication tapering, three Preparatory Sessions, baseline assessments (including Baseline CAPS-5), leading to Enrollment Confirmation.
- Treatment Period: three Experimental Sessions, and three Integrative Sessions following each Experimental Session including CAPS-5 assessments.
- Follow-up Period and Study Termination: Primary Outcome CAPS-5 assessment and Study Termination visit.
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
- Triple (Participant, Care Provider, Investigator)
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
- •At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months.
- •Fluent in speaking and reading the predominantly used or recognized language of the study site (English).
- •Must be a veteran enrolled at a VA Healthcare Center in the Greater Los Angeles area.
- •Able to swallow pills.
- •Agree to have study visits audiovisually recorded, including Experimental Sessions, IR assessments, and non-drug therapy sessions.
- •Able to 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 the participant becoming unwell or unreachable.
- •Able to identify appropriate support person(s) to stay with the participant on the evenings of Experimental Sessions if needed.
- •May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease.
- •May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
- •Body weight of at least 45 kilograms (kg). Participants with a body weight of 45-48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg/m
- •BMI must be within 18 to 32 kg/m2 (inclusive).
- •A person able to be pregnant (PABP) must use a highly effective contraceptive method.
排除标准
- •Are not able to give adequate informed consent.
- •Have evidence or history of significant medical or psychiatric disorders.
- •Are abusing illegal drugs.
- •Unable or unwilling to safely taper off prohibited psychiatric medication.
- •Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician.
研究组 & 干预措施
MDMA-Assisted Therapy
Participants will receive a flexible divided-dose of MDMA plus therapy at Experimental Sessions.
干预措施: 3,4-methylenedioxymethamphetamine (Drug)
Low Dose D-Amphetamine Assisted Therapy
Participants will receive a flexible divided dose plus therapy at Experimental Sessions.
干预措施: Therapy (Behavioral)
Low Dose D-Amphetamine Assisted Therapy
Participants will receive a flexible divided dose plus therapy at Experimental Sessions.
干预措施: d-amphetamine (Drug)
MDMA-Assisted Therapy
Participants will receive a flexible divided-dose of MDMA plus therapy at Experimental Sessions.
干预措施: Therapy (Behavioral)
结局指标
主要结局
Compare changes in PTSD symptom severity in the MDMA vs active control group.
时间窗: Visit 17 (approximately 14 weeks after enrollment)
The Primary Outcome measure will be the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score from Baseline to Visit 17, assessed by a blinded study staff rater. 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
- Compare changes in clinician-rated functional impairment in the MDMA vs active control group.(Visit 17 (approximately 14 weeks after enrollment))
研究者
Stephen Robert Marder
Co-Principal Investigator
VA Greater Los Angeles Healthcare System