ACTRN12624000869572尚未招募1 期
Pilot study of the feasibility and acceptability of administration of psilocybin in healthy volunteers within a marae setting
Matai Medical Research Institute0 个研究点目标入组 12 人开始时间: 2024年7月16日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
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 65 Years（—）
- 性别
- All
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.Maori, of any gender identity aged, 18-65 years.
- •4.For heterosexually active persons of child-bearing potential: agree to use an effective or highly effective contraception for at least one month prior to screening and agreement to use such a method for one month after follow-up is completed
- •5.For heterosexually active males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. These participants must also agree not to donate sperm until at least 3 months after receiving the study drug
排除标准
- •1.Current or past history of schizophrenia or other psychotic disorders, or bipolar I or II disorder. Also excluded will be individuals with a known first-degree relative with these disorders.
- •2.Risk of suicide as determined by The Columbia-Suicide Severity Rating Scale (C-SSRS).
- •3.Current diagnosis of depression, any anxiety disorder, post-traumatic stress disorder (PTSD), or eating disorder. Previous diagnoses are acceptable provided remission has been stable for at least three years.
- •4.Substance dependence in the previous 6 months. Use 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).
- •5.Problematic use of alcohol defined as a score on the Alcohol Use Disorders Identification Test (AUDIT) of 16 or greater.
- •6.Body Mass Index (BMI) <18 and > 35.
- •7.Planned or current pregnancy or lactation.
- •8.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.
- •9.Significant renal or hepatic impairment.
- •10.Abnormal 12-lead electrocardiogram (ECG) as judged by a study physician.
- •11.Any unstable medical or neurological condition.
- •12.Regular use of any medication/supplements deemed to be contraindicating as judged by a study physician
- •13.Treatment with another investigational drug or other intervention within 2 months.
- •14.Use of serotonergic psychedelic drugs in the last year.
- •15.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
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