ACTRN12622000463774已完成1 期
Safety, tolerability, and feasibility of psilocybin-facilitated treatment for methamphetamine use disorder: A pilot study (Psi-MA): A pilot study (Psi-MA)
St. Vincent's Hospital, Sydney0 个研究点目标入组 14 人开始时间: 2022年3月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
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
- 25 Years 至 o limit（—）
- 性别
- All
入选标准
- •·Aged 25 years and above
- •·Meet DSM-5 criteria for methamphetamine use disorder (MAUD) as determined by an Addiction Specialist
- •·Used MA on less than 16 out of the prior 28 days
- •·Currently seeking treatment for methamphetamine use disorder
- •·Have at least one urine drug screen positive for methamphetamine within 1 month of trial registration
- •·Ability to read/write in English
- •·Availability of a friend or family member into whose care the participant can be released following their drug administration session for the subsequent 24 hours
- •·Home-like environment in which to be cared for the 24 hours following psilocybin dosing
- •·In good general health as assessed by detailed medical history and physical examination
- •·Abstinence from methamphetamine, other illicit drugs (including extra-medical use of opioids and benzodiazepines), and alcohol for at least 2 days prior to psilocybin administration as confirmed via urinalysis and no signs of intoxication or withdrawal on the day of psilocybin administration
- •·Good engagement with psychotherapy team at pre-psilocybin psychotherapy session immediately prior to psilocybin dosing session, and consensus on good alliance from both therapists.
- •·Can swallow pills
排除标准
- •·Women who are pregnant or breast feeding or of childbearing potential and not willing to avoid becoming pregnant during the study
- •·Medically significant condition which, in the opinion of the investigator would render a patient unsuitable for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc).
- •·Current hypertension uncontrolled by a single antihypertensive (exceeding 140 mmHg systolic and 90 mmHg diastolic after 15 minutes of rest, averaged across four assessments on at least two separate days.)
- •·History of psychiatric illness other than substance use disorder that is severe within the last 5 years as assessed by a psychiatrist, or any other condition that may compromise patient safety as assessed by psychiatrist
- •·Current use of antidepressant medication, specifically monoamine oxidase inhibitors, antipsychotic medications, St. John's Wort, or other medications as determined by the study psychiatrist
- •·Any of the following on clinical interview with a psychiatrist:
- •oHistory of any drug induced psychosis or any psychotic disorder or psychotic episode
- •oHistory of bipolar I or II disorder
- •oHistory of anorexia nervosa or bulimia nervosa
- •oFirst or second-degree relatives with history of any psychotic disorders, or bipolar I or II disorders
- •oCurrent suicidal or homicidal ideation
- •·History of any other illicit drug, illicit or prescribed benzodiazepine use extra-medical use of opioids within the 2 days preceding psilocybin administration. People receiving opioid substitution therapy who otherwise meet the eligibility criteria may be included.
- •·History of alcohol use disorder within the preceding 3 months
- •·History of cannabis use disorder within the preceding 3 months
- •·Use of a classical hallucinogen (LSD, DMT, psilocybin, mescaline, salvia divinorum, ibogaine) within the preceding 28 days.
- •·Planning to move from the Sydney area in the next 6 months or any other reason precluding follow up in this time period (e.g. likely travel or imprisonment)
- •·Contraindications of MRI (metallic objects in the body, claustrophobia, difficulty with prior MRI)
- •·Unstable housing or homeless
- •·Inability to attend all screening visits
研究者
相似试验
招募中
1 期
Open-Label Psilocybin Study in Transdiagnostic PopulationTransdiagnosticDepression - Major Depressive DisorderPTSD SymptomsPTSDSubstance UseSubstance Use Disorder (SUD)OCDAnxietyNCT06442423Yale University50
已完成
1 期
Safety and tolerability of psilocybin-assisted physiotherapy in healthy volunteersFunctional neurological disorderMental Health - Other mental health disordersNeurological - Other neurological disordersACTRN12621000560897Austin Health13
招募中
Unknown
Psilocybin administration for treatment-resistant depressiodepressionD061218Treatment-resistant depressionJPRN-jRCTs031230351chida Hiroyuki12
进行中（未招募）
1 期
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant DepressioTreatment-Resistant Depression (P-TRD)MedDRA version: 21.1Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeSystem Organ Class: 100000004873MedDRA version: 21.1Level: LLTClassification code 10025463Term: Major depressive disorder, single episodeSystem Organ Class: 100000004873EUCTR2017-003288-36-CZCOMPASS Pathfinder, Limited216
进行中（未招募）
1 期
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant DepressioEUCTR2017-003288-36-PTCOMPASS Pathfinder Limited216