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Personality and Drug Use (PDU) (PDU)

2022年4月23日 更新者:Maggie Kiraga、Quantified Citizen Technologies Inc.
The study aims to assess whether the use of drugs relates to personality ratings. Specifically, we plan to investigate if people with different histories of substance use differentiate on personality assessments (current and past).

研究概览

地位

撤销

条件

详细说明

The study aims to assess the association between the use of various substances (including psychedelic and non-psychedelic drugs) and personality profiles. Specifically, the association between past drug usage and personality profiles will be investigated. As psychedelics were found to influence changes in personality over time, the present study aims to measure both the current personality profile (via the Big Five Inventory-44 (BFI)) and perceived retrospective changes in personality (via a self-constructed Retrospective Personality Scale (RPS)). To our knowledge, no study has explored the diversity of substance use histories in relation to individual current and retrospective personality traits and aggregate personality profiles.

This project aims to survey a large number of participants from all around the world, using a mobile app-based survey. The remote character of the study will increase its accessibility and diversity, which are common shortcomings in the psychedelic line of research. Additionally, a remote, anonymous study setup with no face-to-face interactions might help overcome any potential concerns participants may have regarding the sharing of sensitive information (e.g., reports on illicit substance use).

To increase scientific transparency and for educational purposes, the study team plans to share results summaries (comparisons of personalized results with the aggregated ones among participants sharing similar characteristics e.g., age, substance use history), which might be an additional motivating factor for study completion. Lastly, given that drug use in the natural environment (excluding laboratory/experimental setting) is characterized by large substance diversity and poly-drug use, we aim for a large sample size (with a minimum of 36 subjects per substance(s) category) to perform subgroup analyses. Therefore, this large-scale, low-budget, naturalistic, retrospective, observational study aims to shed light on the aforementioned gap in the literature and to lay a foundation of evidence for further (observational and experimental) research within the field.

研究类型

观察性的

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adults (age of 18 or above) of full mental and legal capacities.

描述

Inclusion Criteria:

  • 18 years of age or older
  • full legal and mental capacity
  • access to a smartphone (iOS and Android) with internet

Exclusion Criteria:

  • not fluent in English
  • not able to read

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:追溯

队列和干预

团体/队列
Psychedelics-only Group

A group of participants who reported using in their past psychedelic substances only (both classical and non-classical psychedelics are included). Specifically, in the current study this group included reports on the following substances:

Psilocybin (magic mushrooms, truffles) LSD (acid) Mescaline (peyote, san pedro) Dimethyltryptamine (DMT) Ayahuasca 5-MeO-DMT 3-MMC Ibogaine Salvia Phenethylamines (2C family)

Stimulants-only Group

A group of participants who reported using in their past drugs identified as stimulating compounds only (both recreational and prescribed usages are included). Stimulating compounds are considered, in the context of the current study, substances that increase the overall activity of the central nervous system. Specifically, in the current study this group included reports on the following substances:

Cocaine Crack Amphetamines Methamphetamines Prescription stimulants (e.g., Adderall, Ritalin, Concerta)

镇静剂组

一组参与者报告说他们过去曾使用过被确定为抑郁化合物的药物(包括娱乐性和处方药)。 在当前研究的背景下,抑郁化合物被认为是降低中枢神经系统整体活动的物质。 具体来说,在当前的研究中,该小组包括了关于以下物质的报告:

苯二氮卓类阿片类药物(海洛因、鸦片、氢可酮、羟考酮、羟吗啡酮、可待因、芬太尼的消遣性使用)处方阿片类药物

大麻素组

一组参与者报告说他们过去只使用过大麻素化合物(包括娱乐用途和处方用途)。 具体来说,在当前的研究中,该小组包括了关于以下物质的报告:

THC(大麻,大麻) CBD 医用大麻(THC 和 CBD)

Psychedelic and Non-psychedelic Substances Group

A group of participants who reported using in their past drugs identified as psychedelics and stimulants and/or depressants (both recreational and prescribed usages are included). In this group participants will be included who reported using at least one non-psychedelic drug additionally to a psychedelic one. Specifically, the following options were provided:

  1. Psychedelic compounds:

    Psilocybin (magic mushrooms, truffles) LSD (acid) Mescaline (peyote, san pedro) Dimethyltryptamine (DMT) Ayahuasca 5-MeO-DMT 3-MMC Ibogaine Salvia Phenethylamines (2C family)

  2. Non-psychedelic compounds:

THC (cannabis, marijuana) Medical Cannabis (both THC and CBD) CBD MDMA (ecstasy) Ketamine Cocaine Crack Amphetamines Methamphetamines Prescription stimulants (e.g., Adderall, Ritalin, Concerta) Benzodiazepines Opiates (e.g., heroin, opium, hydrocodone, oxycodone, oxymorphone, codeine, fentanyl) Prescription opioids

物质天真组
一组参与者报告过去没有使用过当前研究中列出的任何物质,也没有报告使用过其他物质(不包括酒精和尼古丁)。 当且仅当参与者从物质使用调查(第 1 项)中选择“以上都不是”选项时,他们才会被分配到该组。

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Current Personality Profile
大体时间:Single baseline measurement
Raw scores on each of dimensions of the Big Five Inventory
Single baseline measurement

次要结果测量

结果测量
措施说明
大体时间
Changes in Personality Profile
大体时间:Single baseline measurement
Raw scores on the positive and negative dimensions of the self-constructed (for the study needs) Retrospective Personality Scale
Single baseline measurement

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Kim PC Kuypers, PhD、Maastricht University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2022年4月1日

初级完成 (预期的)

2023年4月1日

研究完成 (预期的)

2023年4月1日

研究注册日期

首次提交

2021年12月17日

首先提交符合 QC 标准的

2021年12月17日

首次发布 (实际的)

2022年1月6日

研究记录更新

最后更新发布 (实际的)

2022年4月29日

上次提交的符合 QC 标准的更新

2022年4月23日

最后验证

2022年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • QCPUBLICPDU1

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

The study will be pre-registered on the Open Science platform, where study details will be shared and regularly updated. This will be an open access project, meaning that all collected data and data analysis will be made available for all interested parties (via OSF platform). Additionally, we will share the individual summary reports with all participants who completed the study. The report will be accessible via a mobile app used to collect the study data.

IPD 共享时间框架

The raw data and clinical study report will be made available within 12 months from the end date of data collection.

IPD 共享访问标准

Open access

IPD 共享支持信息类型

  • 研究协议
  • 统计分析计划 (SAP)
  • 知情同意书 (ICF)
  • 临床研究报告(CSR)
  • 解析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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