ACTRN12624000910505尚未招募1 期
The neuronal mechanisms underlying food choice and reward under psilocybin in healthy adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
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
- 20 Years 至 50 Years（—）
- 性别
- All
入选标准
- •No MR contraindications.
- •Willing to be abstinent from illicit or extra-medical drug and alcohol use for at least 2 days prior to psilocybin dosing.
- •Able to swallow pills.
- •Proficient in English, such that their literacy and comprehension are sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent.
排除标准
- •Current or previously diagnosed psychiatric disorder (as determined by the SCID).
- •Current or past history within the last 5 years of meeting DSM-5 criteria for alcohol or drug
- •dependence (excluding caffeine and nicotine), as determined by clinical interview and use of screening measures.
- •An immediate family member with a diagnosed psychotic disorder (Schizophrenia spectrum Disorder or Bipolar I or II Disorder).
- •History of suicide attempts.
- •Use of any hallucinogen or psychedelic (including psilocybin, MDMA, LSD, mescaline, DMT, and other similar hallucinogenic compounds) within the past 12 months.
- •Taking a contraindicated medication (SSRIs, SNRIs, MAOIs) at the time of recruitment.
- •Current use of any of the following potent metabolic inducers or inhibitors: Inducers - Rifamycin (rifampin, rifabutin, rifapentine), anticonvulsants (carbamazepine, phenytoin, phenobarbital), nevirapine, efavirenz, paclitaxol, St John's Wort; Inhibitors - all HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin.
- •Known conditions putting participants at risk for hypercalcaemia, Cushing's syndrome, hypoglycaemia, syndrome of inappropriate antidiuretic hormone secretion, or carcinoid syndrome.
- •People with a medical requirement that they receive any of the following drugs with low therapeutic index within 12 hours after receiving psilocybin: ergot alkaloids, pimozide, midazolam, triazolam, lovastatin, simvastatin, fentanyl.
- •A diagnosis of epilepsy or previous seizures.
- •A diagnosis of Hepatic dysfunction or Renal insufficiency
- •Body weight < 48kg or >100kg.
- •Taking long-acting opioid pain medications (e.g. oxycodone sustained-release, morphine sustained release -- which are usually taken at 12-hour intervals) unless the last dose occurred at least 6 hours before psilocybin administration; such medication will not be taken again until at least 6 hours after psilocybin administration.
- •Cardiovascular conditions: uncontrolled hypertension, (Systolic >140 and diastolic >90) angina, a previous clinically significant ECG abnormality (e.g. atrial fibrillation, arrhythmia, prolongation of QT/QTc interval), TIA in the last 6 months, stroke or cerebrovascular disease, peripheral or pulmonary vascular disease (no active claudication).
- •Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc).
- •Treatment in another clinical trial involving an investigational product.
- •A positive pregnancy test at initial assessment or during the study.
- •Are unable to give adequate informed consent.
- •Allergy to gelatine or lactose.
研究者
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