A Phase 1/2 Open-Label Treatment Development Study of Methylenedioxymethamphetamine (MDMA)-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic Posttraumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
研究概览
简要总结
The goal of this clinical trial is to learn if cognitive-behavioral conjoint therapy (CBCT) in combination with MDMA-assisted therapy is safe and effective in people with chronic PTSD and their partners.
The main question it aims to answer is: Does MDMA-assisted CBCT reduce PTSD symptoms in people with chronic PTSD?
Participants (chronic PTSD patients and their partners) will undergo three non-drug preparatory therapy sessions, followed by two MDMA-assisted therapy sessions. Each MDMA-assisted therapy session will be followed by five non-drug integrative therapy using CBCT.
详细描述
Cognitive-Behavioral Conjoint Therapy (CBCT) for PTSD is a three-phase, 15-session, manualized treatment. This Phase 1/2 open-label study will combine methods for conducting MDMA-assisted therapy with methods from the CBCT for PTSD in order to treat 10 participants with chronic PTSD and their partners (intimate or non-intimate significant other who does not have a current diagnosis of PTSD) in order to explore whether combined treatment is effective.
Each therapy team will have one therapist trained and experienced in MDMA-assisted therapy and one therapist trained and experienced in CBCT. During the first experimental session, both participants will receive 75 mg of midomafetamine HCl followed 1.5 to 2 hours later by an optional supplemental half-dose of 37.5 mg. During the second experimental session, an initial dose of either 100 or 75 mg of midomafetamine HCl will be administered to both participants followed by an optional supplemental half-dose of either 50 mg or 37.5 mg. The primary objective of this study is to assess changes in PTSD symptoms from Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity scores in PTSD participants.
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
- 是
入选标准
- •All inclusion criteria for the PTSD and Concerned Significant Other (CSO) are identical except for first two items, marked below:
- •PTSD+ participant: Meet DSM-5 criteria for current PTSD and satisfies PTSD criteria via CAPS
- •CSO participant: Meet criteria for V62.89 Other Problem Related to Psychosocial Circumstances under Diagnostic and Statistical Manual 5 (DSM-5), as determined through clinical interview, for current psychosocial circumstances contributing to relationship distress with intimate or non-intimate partner
- •Are at least 18 years old
- •If in psychotherapy, willing and able to maintain that schedule without changing it
- •Are willing to refrain from taking any psychiatric medications during the study period, with the exception of gabapentin when prescribed for pain control.
- •Willing to remain overnight at the study site
- •Are willing to be driven home the morning after the experimental sessions, after the integrative therapy session
- •Are willing to commit to medication dosing, experimental sessions, follow-up sessions, to complete evaluation instruments and commit to be contacted for all necessary telephone contacts
- •Are willing to remain overnight at the study site after each experimental session until after the integrative session occurring the next morning
- •Must have a negative pregnancy test at study entry and prior to each experimental session if able to bear children, and must agree to use adequate birth control through 10 days after the last dose of MDMA.
- •Must provide a contact (relative, spouse, close friend or other caregiver other than the CSO participant) who is willing and able to be reached by the Clinical Investigators in the event of a participant becoming suicidal.
- •Must agree to inform the Clinical Investigators within 48 hours of any medical conditions and procedures
- •Are proficient in speaking and reading English
- •Agree to have all clinic visit and Integrative Sessions recorded to audio and video
- •Agree to not participate in any other interventional clinical trials during the duration of this study
排除标准
- •The following exclusions are identical for PTSD+ and CSO participants except for the following, marked below:
- •CSO participant only: Have diagnosis of current PTSD not in remission
- •Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control
- •Have evidence or history of significant medical disorders
- •Have hypertension
- •Have liver disease; asymptomatic participants with Hepatitis C who have previously undergone evaluation and successful treatment is permitted.
- •History of hyponatremia or hyperthermia
- •Weigh less than 48 kg
- •Have used "Ecstasy" (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the MDMA-assisted session
- •Are not able to give adequate informed consent
研究组 & 干预措施
MDMA-assisted therapy and CBCT
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy.
干预措施: MDMA (Drug)
MDMA-assisted therapy and CBCT
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy.
干预措施: CBCT (Behavioral)
MDMA-assisted therapy and CBCT
Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy.
干预措施: Therapy (Behavioral)
结局指标
主要结局
Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
时间窗: Primary Endpoint (Visit 16, approximately 2 months later)
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. 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.
Change From Baseline to Primary Endpoint CAPS-5 Total Severity Score
时间窗: Baseline to Primary Endpoint (Visit 16, approximately 2 months later)
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. 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
- Baseline Partner Couples Satisfaction Index (CSI)(Baseline (screening))
- Primary Endpoint Emotion Regulation Questionnaire (ERQ) Suppression Subscale(Primary Endpoint (Visit 16, approximately 2 months later))
- Primary Endpoint Pittsburgh Sleep Quality Index (PSQI)(Primary Endpoint (Visit 16, approximately 2 months later))
- Baseline Pittsburgh Sleep Quality Index (PSQI)(Baseline (screening))
- Baseline Patient Beck Depression Inventory-II (BDI-II)(Baseline (screening))
- Primary Endpoint Patient Beck Depression Inventory-II (BDI-II)(Primary Endpoint (Visit 16, approximately 2 months later))
- Baseline Patient Couples Satisfaction Index (CSI)(Baseline (screening))
- Primary Endpoint Patient Couples Satisfaction Index (CSI)(Primary Endpoint (Visit 16, approximately 2 months later))
- Primary Endpoint Partner Couples Satisfaction Index (CSI)(Primary Endpoint (Visit 16, approximately 2 months later))
- Baseline Trauma and Attachment Beliefs Scale (TABS)(Baseline (screening))
- Baseline Patient PTSD Checklist-5 (PCL-5)(Baseline (screening))
- Primary Endpoint Patient PTSD Checklist-5 (PCL-5)(Primary Endpoint (Visit 16, approximately 2 months later))
- Baseline Partner-rated PTSD Checklist-5 (PCL-5)(Baseline (screening))
- Primary Endpoint Partner-rated PTSD Checklist-5 (PCL-5)(Primary Endpoint (Visit 16, approximately 2 months later))
- Primary Endpoint Trauma and Attachment Beliefs Scale (TABS)(Primary Endpoint (Visit 16, approximately 2 months later))
- Baseline Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale(Baseline (screening))
- Primary Endpoint Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale(Primary Endpoint (Visit 16, approximately 2 months later))
- Baseline Emotion Regulation Questionnaire (ERQ) Suppression Subscale(Baseline (screening))