MDMA-Assisted Therapy for Mental Healthcare Providers

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат MDMA Hydrochloride
  Initial dose of 120 mg MDMA HCl in a therapeutic setting, followed 1.5 to 2 hours later by a supplemental dose of 40 mg MDMA HCl. Supplemental doses may be withheld if tolerability issues emerge or it is declined by the participant.

Первичные конечные точки

• Mental Health Continuum-Short Form (MHC-SF) [Срок оценки: At baseline and 28 days post-treatment]

Вторичные конечные точки (1)

• The Maslach Burnout Inventory - Human Services Survey (MBI-HSS) [Срок оценки: At baseline and 28 days post-treatment]

Критерии участия

Критерии включения

• 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)).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• The Parsons Research Center for Psychedelic Healing — New York

Идентификаторы

NCT: NCT07102576 · STUDY-24-00412

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗