ACTRN12624000871549尚未招募2 期
Pilot investigation of psychedelic-assisted psychotherapy for treatment of post-traumatic stress disorder (PTSD) in people diagnosed with co-occurring borderline personality disorder – a controlled before-and-after study
Spectrum Personality Disorder Service for Victoria0 个研究点目标入组 20 人开始时间: 2024年7月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 90 Years（—）
- 性别
- Female
入选标准
- •Female clients aged 18 years or older who are eligible for treatment from Spectrum’s Complex Care Team (reserved for clients with severe and high risk presentations for whom manualised specialised treatment programs are not indicated)
- •Diagnosis of PTSD (or Complex PTSD)
- •Diagnosis of BPD
- •Effective method of contraception if of child-bearing age
- •Fluent in written and spoken English language
排除标准
- •Diagnosis of Narcissistic or Antisocial Personality Disorder (which lack the attachment pathology we believe is amenable to the actions of MDMA)
- •Diagnosis or likely diagnosis of Autism Spectrum Disorder or traits
- •Currently taking prescription medication for attention deficit hyperactivity disorder (ADHD)
- •Intellectual disability severe enough to affect the provision of informed consent and preclude engagement in psychological treatment programs
- •Serious medical illness (particularly those affecting the cardiovascular system)
- •Pregnant or breast-feeding
- •Medication prescribed to treat psychiatric symptoms. Contraindicated substances and medications include MDMA metabolites or analogues, anaesthetics, muscle relaxants, amphetamines and stimulants, benzodiazepines, ethanol, opioids, antidepressants (e.g. bupropion, sertraline, venlafaxine, moclobemide, and citalopram), olanzapine and any medication that increases the concentration of serotonin. Study participation will require cessation of these medications prior to commencing the study.22 In practice, a washout period will be required, generally two weeks for most psychotropic medications. The tapering and ceasing will only be initiated when a MDMA dosing date is determined and then the tapering start will be backdated from this. It is possible that a participant's symptoms will worsen during this tapering and ceasing phase. Cessation of medication will be carried out under clinical supervision where it is considered safe to do so. The decision to cease medications will be for the participant and their usual treating practitioner to determine.
研究者
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