- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05516823
Personality and Drug Use (PDU)
Study Overview
Status
Intervention / Treatment
Detailed Description
The study aims to assess the association between the use of various substances (including psychedelic and non-psychedelic drugs) and personality profiles. Specifically, the study will investigate if people with different histories of drug use differ in personality profiles. As psychedelics were found to influence changes in personality over time, the investigators sought 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 investigators' knowledge, no study has explored the diversity of substance use histories in relation to individual current and retrospective personality traits and aggregate personality profiles.
The investigators aim 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 and 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 (comparing personalized results with the aggregated results of participants with similar socio-demographic profiles), investigators plan to share personalized results summaries with participants of the study, which might be an additional motivating factor for study completion. In conclusion, this large-scale, low-budget, naturalistic, retrospective, observational study aims to shed light on the aforementioned gap in the literature and lay a foundation of evidence for further research.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Maggie K Kiraga, MSc
- Phone Number: 001 4373249251
- Email: maggie@quantifiedcitizen.com
Study Contact Backup
- Name: Kim PC Kuypers, PhD
- Email: fpn-pim_P138@maastrichtuniversity.nl
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years of age or older
- full legal and mental capacity
- access to a smartphone with internet to fill in the study measures (available for iOS and Android)
Exclusion Criteria:
- lack of proficiency in English
- visual impairments (not able to use mobile devices)
- illiteracy
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Depressants-only Group
A group of participants who reported using in their past drugs identified as depressing compounds only (both recreational and prescribed usages are included). Depressing compounds are considered, in the context of the current study, substances that decrease the overall activity of the central nervous system. Specifically, in the current study this group included reports on the following substances: Benzodiazepines Opiates (recreational use of heroin, opium, hydrocodone, oxycodone, oxymorphone, codeine, fentanyl) Prescription opioids |
Self-reported past usage of drugs belonging to different chemical groups.
|
|
Cannabinoids Group
A group of participants who reported using in their past cannabinoids compounds only (both recreational and prescribed usages are included). Specifically, in the current study this group included reports on the following substances: THC (cannabis, marijuana) CBD Medical Cannabis (both THC and CBD) |
Self-reported past usage of drugs belonging to different chemical groups.
|
|
Substance-naive Group
A group of participants who reported no past experience with any of the substances listed in the current study nor reported using other substances (excluding alcohol and nicotine).
Participants will be assigned to this group if and only if they choose the "None of the above" option from the Substance Use Survey (item 1).
|
|
|
Group: 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) |
Self-reported past usage of drugs belonging to different chemical groups.
|
|
Group: 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) |
Self-reported past usage of drugs belonging to different chemical groups.
|
|
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: 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) Non-psychedelic compounds: THC (cannabis, marijuana) CBD Medical Cannabis (both THC and 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 |
Self-reported past usage of drugs belonging to different chemical groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in scores on Big Five Inventory (BFI-44)
Time Frame: Measured twice: once referring to participants' personality from a period of their youth (18-21 years old) and the second time: the current moment, how they perceived their personality in general terms.
|
The study will collect measures of past (youth) and current BFI scores.
A separate score will be reported for each of the 5 personality traits measured by the inventory.
Each score is computed by averaging the items associated with a given domain.
Scores for each domain vary from 1 to 5, with higher scores meaning that a given trait is more present and noticeable in personality of the person that provided the answers.
|
Measured twice: once referring to participants' personality from a period of their youth (18-21 years old) and the second time: the current moment, how they perceived their personality in general terms.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in scores on Retrospective Personality Scale (RPS)
Time Frame: Measured twice: once referring to participants' personality from a period of their youth (18-21 years old) and the second time: the current moment, how they perceived their personality in general terms.
|
The study will collect measures of past (youth) and current RPS scores.
A separate score will be reported for each of the 2 personality domains: positive and negative.
Each of the 20 items is scored on a 3-point scale, using the following encoding: -1 (=Less), (=Without change), 1 (=More).
Mean scores of 10 items for each of the domains (positive and negative) form the total score.
Score Interpretation: For the positive domain, the mean score of 0 indicates no changes in personality, whereas the positive mean score (larger than 0) indicates positive changes in personality and scores below 0 point out negative changes.
The reverse interpretation is true for the negative domain, with a mean score of 0 indicating no changes.
|
Measured twice: once referring to participants' personality from a period of their youth (18-21 years old) and the second time: the current moment, how they perceived their personality in general terms.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kim PC Kuypers, PhD, Maastricht University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21017 Personality and Drug Use
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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