A Phase 1, Open-Label Study to Assess Psychological and Biological Effects of MDMA Assisted Therapy When Administered to Mental Health Providers in Training to be MDMA-Assisted Therapists
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mental Health Continuum-Short Form (MHC-SF)
研究概览
简要总结
This is a phase 1, open-label study to assess changes in mental well-being following MDMA administration within a therapeutic setting, in mental health providers who are in training to become MDMA assisted therapists. Secondary outcome measures will examine the effects on provider burnout, provider self-efficacy, mood, self-compassion, quality of life, and other psychological factors. Participants will work with a co-therapy pair as they engage in a preparatory session, one experimental session with MDMA, and an integration session the following day.
详细描述
This study is investigating the psychological and biological effects and safety of MDMA-assisted therapy (MDMA-AT) in healthy volunteers who are: 1) mental healthcare providers or trainees, and 2) learning or have been certified to conduct MDMA-AT. As research in MDMA-AT expands, there is a need to evaluate the safety and efficacy of MDMA-assisted therapy in healthy volunteers, in order to better understand its effects in populations beyond clinical samples and to inform future comparisons. This study will assess whether a relatively brief intervention (consisting of one MDMA-AT session with one preparatory and one integration session) can improve overall mental wellbeing in a healthy sample of mental healthcare providers, while also evaluating its effects on provider burnout, self-assessed counselor efficacy, mood, psychological flexibility, quality of life, and experiential avoidance. In addition, this study supports continued training for new MDMA-AT providers, including the option for their own MDMA experience to expand on their knowledge of the subjective effects and therapeutic potential of MDMA-AT and enhance their qualifications to provide that therapy. Participants will engage in structured preparation, treatment, and follow-up, guided by trained clinical professionals. Assessments will take place throughout the study to monitor mental health outcomes and ensure participant well-being. Participation will consist of: - Screening Period (up to 4 weeks): Phone screen, informed consent, eligibility assessment, and enrollment. - Preparatory Period (1-4 weeks): Preparatory session with study clinicians, baseline assessments. - Treatment Period (2 days): Experimental session (MDMA administered in a controlled therapeutic setting) followed by an integrative session the next day. - Follow-Up Period (up to 4 weeks): Follow-up visit approximately one month after experimental session, outcome assessments, and study termination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Are at least 18 years at the time of signing the informed consent.
- •Fluent in English
- •Able to swallow pills
- •Agree to have study visits audiovisually recorded
- •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.
- •Must be licensed, license-eligible, or trainees in a relevant healthcare/mental health profession
- •Must be learning or have been certified to conduct MDMA-assisted therapy through the Lykos MDMA-Assisted Therapy Training program or authorized affiliate program
- •Body weight of at least 45 kilograms (kg; or 100 pounds (lbs)).
- •Exclusion Criteria
- •Have engaged in a new form of psychiatric or mental health care within 12 weeks of enrollment
- •Have a current alcohol or cannabis use disorder of any severity within the 12 months prior to enrollment
- •Have a substance use disorder of any severity within 12 months prior to enrollment
- •Any suicidal ideation within the last 6 months
- •Repetitive or recent use of Ecstasy/MDMA
- •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
- •Meet diagnostic criteria for a Major Depressive Episode currently or within the prior 3 months or meet diagnostic criteria for a current anxiety disorder assessed
- •Have a current eating disorder with compensatory behaviors
- •Have a history of, or a current primary psychotic disorder or bipolar disorder
- •Previous participation in a clinical trial that included administration of MDMA
- •Individuals in a personal relationship with the site investigator
- •Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of contraception
排除标准
- 未提供
研究组 & 干预措施
Open-Label
One session of MDMA-Assisted Therapy
干预措施: MDMA Hydrochloride (Drug)
结局指标
主要结局
Mental Health Continuum-Short Form (MHC-SF)
时间窗: At baseline and 28 days post-treatment
The MHC-SF is a self-report measure consisting of 14 questions rated for the frequency at which they are experienced, on a scale from "0-never" to "5-every day" within the past month. The MHC-SF is a shortened version of the Mental Health Continuum Long Form (MHC-LF), a 40-item measure which was developed to assess emotional, social, and psychological well-being, a three factor structure validated in national and international populations. The MHC-SF was developed using a subset of items from the MHC-LF to represent each of these three well-being constructs: The MHC-SF yields a total score range of 0-70, where higher scores reflect greater mental well-being. Subscale ranges are: Emotional Well-Being: 0-15 (3 items), Psychological Well-Being: : 0-30 (6 items), and Social Well-Being: 0-25 (5 items). Subscale scores reflect functioning in each domain, while the total score captures overall mental well-being.
次要结局
- The Maslach Burnout Inventory - Human Services Survey (MBI-HSS)(At baseline and 28 days post-treatment)
研究者
Rachel Yehuda
Professor
Icahn School of Medicine at Mount Sinai