ACTRN12624000668505尚未招募1 期
An open-label trial to test menstrual cycle effects and tolerance to LSD microdosing in healthy menstruating persons (MDMENS).
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 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 46 Years（—）
- 性别
- Female
入选标准
- •1.Provision of signed and dated informed consent form.
- •2.Stated willingness to comply with all study procedures and availability for the duration of the study.
- •3.Aged, 18-46 years.
- •4.For heterosexually active persons of child-bearing potential: agree to use non-hormonal contraception during the Laboratory and Home Dosing periods.
- •5.To have regular menstrual cycles
排除标准
- •1.Any item 1-13 of the Premenstrual Symptoms Screening Tool scoring above mild” and any item A-E scoring above mild.
- •2.Any psychiatric diagnosis flagged by Clinical Interview
- •3.Confirmed first degree relative with schizophrenia or other psychotic disorder, or bipolar I or II disorder.
- •4.Risk of suicide as determined by The Columbia-Suicide Severity Rating Scale (C-SSRS).
- •5.Substance dependence in the previous 6 months as assessed by clinical interview with a New Zealand modified version of the NIDA (National Institute of Drug Abuse) Modified Alcohol, Smoking and Substance. Involvement Screening Test NM-ASSIST.
- •6.Problematic use of alcohol defined as a score on the Alcohol Use Disorders Identification Test (AUDIT) of 16 or greater.
- •7.Body mass index (BMI) <18 and > 35.
- •8.Planned or current pregnancy or lactation.
- •9.Cardiovascular conditions including abnormal heart rate or blood pressure to be checked at screening. A threshold of exceeding 160 mmHg (systolic) and 90 mmHg (diastolic), averaged across three assessments taken on the screening day will be used. Participants with well-managed hypertension would not be excluded.
- •10.Significant renal or hepatic impairment.
- •11.Diagnosed or probable polycystic ovary syndrome (PCOS)
- •12.Abnormal 12-lead Electrocardiogram (ECG) as judged by a study physician.
- •13.Abnormal laboratory test findings as judged by a study physician.
- •14.Any unstable medical or neurological condition.
- •15.Regular use of any Central Nervous System (CNS) active medications in the last three months
- •16.Use of hormonal contraceptives/steroid hormones in the last three months
- •17.Regular use of any medication/supplements deemed to be contraindicating as judged by a study physician.
- •18.Treatment with another investigational drug or other intervention within 2 months.
- •19.Any lifetime history of psychedelic microdosing.
- •20.Use of serotonergic psychedelic drugs (LSD, psilocybin, Dimethyltryptamine (DMT) etc.) in the last year.
- •21.Any other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial.
研究者
相似试验
进行中（未招募）
Unknown
Sleeping BetterSleep difficulties in patients at ultra-high risk of psychosis and patients diagnosed with non-affective psychosisMental and Behavioural DisordersISRCTN71800376niversity of Oxford1,108
已完成
不适用
The Oxford Access for Students Improving Sleep (OASIS) studyInsomniaISRCTN61272251Medical Sciences Inter-Divisional Research Ethics Committee, University of Oxford2,614
已完成
4 期
A randomised clinical trial evaluating the effect of remifentanil vs fentanyl during cardiac surgery on the incidence of chronic thoracic pain.chronische thoracale pijnchronic thoracic painchronic pain on chestNL-OMON41643Sint Antonius Ziekenhuis126
进行中（未招募）
不适用
Two commonly used anesthesia during cardiac surgery (remifentanil andfentanyl) will be compared; the effect of these anesthesia on thedevelopment of chronic thoracic pain will be measured.EUCTR2013-000201-23-NLSt. Antonius Ziekenhuis
已完成
1 期
Pharmacokinetics of terguride in healthy subjects with known CYP2D6 genotypeCYP2D6 genotypeGenetic DiseasesISRCTN36145549medac GmbH36