NCT07610135招募中1 期
PRISMatic: A Phase 1b Randomized, Double-Armed, Parallel-Group, Placebo-Controlled Trial of Psilocybin Efficacy With or Without Pimavanserin Pretreatment
Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年9月30日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
Twenty healthy adults (≥21 years old) will be enrolled to evaluate the efficacy of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or placebo. Outcome assessments will occur at 1 week and 1 month following psilocybin administration.
The purpose of this study is to clarify the receptor-level mechanisms underlying psilocybin's effects on mood and well-being, along with the associated neurophysiologic signatures. These mechanisms will be examined using psychometric scales, autonomic and fMRI-based neurophysiologic markers, and integrated pharmacokinetic/pharmacodynamic modeling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21 to 65 years old
- •Provision of written informed consent
- •Fluency in English
- •At least high school level of education
- •Right-handed
- •Agree to abstain from any psychoactive drugs on the day prior to and the day of the drug administration session as demonstrated by a negative toxicology report.
- •Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days.
- •Agree not to take any PRN medications on the mornings of drug sessions
- •Agree that for one week before the drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
- •Female participants of childbearing potential must agree to use a highly effective method of contraception throughout the study.
- •Highly effective methods are defined as those that, when used consistently and correctly (alone or in combination), are associated with a failure rate of less than 1% per year.
- •Condoms alone are not considered highly effective.
- •Abstinence is not considered a highly effective method. However, at the investigator's discretion, abstinence may be accepted if, based on the investigator's judgment and knowledge of the participant's usual and preferred lifestyle, it can be reasonably expected to result in 100% effectiveness.
排除标准
- •Non-English speakers and those with language or hearing impairments
- •Left-handedness (assessed by the Edinburgh Handedness Inventory)
- •Any lifetime history of psychedelic use, including serotonergic compounds (e.g., psilocybin, LSD, mescaline, DMT, 5-MeO-DMT) and nontraditional psychedelics (e.g., MDMA, ketamine, ibogaine)
- •History of psychiatric diagnosis in adulthood (≥18 years), including, but not limited to, major depressive disorder, bipolar disorder I and II, psychotic disorders, and substance use disorder.
- •Current use of neuropsychiatric medications, including but not limited to typical/atypical antidepressants, antipsychotics, and stimulants.
- •Lifetime history of substance use disorder
- •Current (within past six months) substance use disorder of moderate or greater severity
- •Clinically significant suicidal ideation (with strong intent or means) within the past 6 months or lifetime history of suicide attempt, current suicidal ideation, or otherwise judged by a study clinician to be more than low risk for suicidality
- •Current use/positive toxicology for illicit drugs at screening and prior to drug administration session (includes illicit, non-prescribed, or prohibited substances such as amphetamines, barbiturates, buprenorphine, benzodiazepines, cocaine, MDMA, methadone, opioids, phencyclidine (PCP), and tetrahydrocannabinol (THC))
- •Nicotine user consuming the equivalent of ≥ 10 cigarettes/day
- •Altered gastrointestinal anatomy [history of surgeries that promote a general intestinal malabsorption (e.g., jejunoileal bypass, jejunocolic bypass, roux-en-Y gastric bypass, vertical banded gastroplasty, gastric band, gastric stapling, sleeve gastrectomy, biliopancreatic diversion with partial gastrectomy, distal gastric bypass, duodenal switch)]
- •Weight < 40kg
- •Have a first degree relative with schizophrenia or other psychotic disorders (except substance/medication-induced or due to another medical condition), or bipolar I disorder
- •MRI contraindications (e.g., claustrophobia incompatible with MRI scanning, medical device or implant incompatible with MRI, prior history as a metal worker and/or certain metallic objects in the body). Must complete MRI screening form and be approved by MRI technologist before each scan.
- •Unable or unwilling to perform study procedures, or inappropriate for further study participation as determined by the PI and/or study clinicians
研究组 & 干预措施
Psilocybin + Pimavanserin
Experimental
Two oral pretreatment doses of pimavanserin (34 mg each) followed by a single oral dose of psilocybin (25 mg)
干预措施: Pimavanserin (Drug)
Psilocybin + Pimavanserin
Experimental
Two oral pretreatment doses of pimavanserin (34 mg each) followed by a single oral dose of psilocybin (25 mg)
干预措施: Psilocybin (Drug)
Psilocybin + Placebo
Placebo Comparator
Two oral pretreatment doses of inactive placebo followed by a single oral dose of psilocybin (25 mg)
干预措施: Inactive Placebo (Drug)
Psilocybin + Placebo
Placebo Comparator
Two oral pretreatment doses of inactive placebo followed by a single oral dose of psilocybin (25 mg)
干预措施: Psilocybin (Drug)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of How Ibuzatrelvir is Taken up Into the Blood of Healthy Adults After Taking Different Tablets of IbuzatrelvirCoronavirus Disease 2019Coronavirus Disease 2019 (COVID-19)COVID-19 (Coronavirus Disease 2019)Upper Respiratory Tract InfectionsRespiratory Tract DiseasesCOVID-19 InfectionCOVID-19 SARS-CoV-2 InfectionLung DiseasesCOVID-19Respiratory Tract InfectionPneumoniaNCT07552779Pfizer17
招募中
2 期
Firmonertinib Combined With Definitive Radiotherapy in Stage III Unresectable EGFR Uncommon Mutant Pulmonary AdenocarcinomaNCT07314216Hunan Cancer Hospital15
尚未招募
不适用
Comparison of a natural bee product (propolis) mouth rinse and chlorhexidine mouth rinse for improving gum health and lowering bacteria after full-mouth deep cleaning in people with moderate gum disease.CTRI/2026/04/107841sanskruti kulkarni40
尚未招募
2 期
A Phase II Study of Neoadjuvant Sacituzumab Tirumotecan in Combination With Iparomlimab and Tuvonralimab in Locally Advanced Cervical CancerCervical CancerNCT07348861Zheng Min25
尚未招募
2 期
Phase IIa Study of BRY812 Monotherapy in Advanced Gynecological MalignanciesNCT07311538BioRay Pharmaceutical Co., Ltd.56