PersonalityPDUNCT05180149
Personality and Drug Use (PDU)
An observational study of Personality, run by Quantified Citizen Technologies Inc..
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Personality
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults (age of 18 or above) of full mental and legal capacities.
Who may be able to join
- 18 years of age or older
- full legal and mental capacity
- access to a smartphone (iOS and Android) with internet
Who cannot join
- not fluent in English
- not able to read
About this study
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).
Read the 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 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.
- Conditions
- Personality
- Keywords
- Personality, Substance Use, Psychedelics, Drugs, Changes in Personality
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) | |
| 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 | |
| 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) | |
| 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 | |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current Personality Profile
Raw scores on each of dimensions of the Big Five Inventory
Measured: Single baseline measurement
Secondary outcomes (1)
Changes in Personality Profile
Raw scores on the positive and negative dimensions of the self-constructed (for the study needs) Retrospective Personality Scale
Measured: Single baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study startApr 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Why it stopped: The sponsor of the study has changed. The study will be released, managed and registered by another institution who will be acting as a responsible party.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PersonalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantified Citizen Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maastricht University, Psychedelic Data Society
- Responsible party
- Principal investigator, Maggie Kiraga, Maastricht University
- Investigators
- Kim PC Kuypers, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180149
- Sponsor's protocol ID
- QCPUBLICPDU1
- Acronym
- PDU
- Status last verified
- Apr 2022
- First submitted
- 17 Dec 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Kiraga MK, Mason NL, Uthaug MV, van Oorsouw KIM, Toennes SW, Ramaekers JG, Kuypers KPC. Persisting Effects of Ayahuasca on Empathy, Creative Thinking, Decentering, Personality, and Well-Being. Front Pharmacol. 2021 Oct 1;12:721537. doi: 10.3389/fphar.2021.721537. eCollection 2021.
PubMed 34658861Bouso JC, Gonzalez D, Fondevila S, Cutchet M, Fernandez X, Ribeiro Barbosa PC, Alcazar-Corcoles MA, Araujo WS, Barbanoj MJ, Fabregas JM, Riba J. Personality, psychopathology, life attitudes and neuropsychological performance among ritual users of Ayahuasca: a longitudinal study. PLoS One. 2012;7(8):e42421. doi: 10.1371/journal.pone.0042421. Epub 2012 Aug 8.
PubMed 22905130Bouso JC, Palhano-Fontes F, Rodriguez-Fornells A, Ribeiro S, Sanches R, Crippa JA, Hallak JE, de Araujo DB, Riba J. Long-term use of psychedelic drugs is associated with differences in brain structure and personality in humans. Eur Neuropsychopharmacol. 2015 Apr;25(4):483-92. doi: 10.1016/j.euroneuro.2015.01.008. Epub 2015 Jan 16.
PubMed 25637267Williams MT, Davis AK, Xin Y, Sepeda ND, Grigas PC, Sinnott S, Haeny AM. People of color in North America report improvements in racial trauma and mental health symptoms following psychedelic experiences. Drugs (Abingdon Engl). 2021;28(3):215-226. doi: 10.1080/09687637.2020.1854688. Epub 2020 Dec 10.
PubMed 34349358Martins SS, Sampson L, Cerda M, Galea S. Worldwide Prevalence and Trends in Unintentional Drug Overdose: A Systematic Review of the Literature. Am J Public Health. 2015 Nov;105(11):e29-49. doi: 10.2105/AJPH.2015.302843.
PubMed 26451760Harm reduction: An approach to reducing risky health behaviours in adolescents. Paediatr Child Health. 2008 Jan;13(1):53-60. doi: 10.1093/pch/13.1.53. No abstract available.
PubMed 19119355
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personality and Drug Use (PDU)
- ClinicalTrials.gov ID
- NCT05180149
- Acronym / sponsor ID
- PDU / QCPUBLICPDU1
- Conditions
- Personality
- Keywords
- Personality, Substance Use, Psychedelics, Drugs, Changes in Personality
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The sponsor of the study has changed. The study will be released, managed and registered by another institution who will be acting as a responsible party.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Quantified Citizen Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Maastricht University, Psychedelic Data Society
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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) |
| 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 |
| 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) |
| 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 |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (age of 18 or above) of full mental and legal capacities.
Key inclusion criteria (3 listed)
- 18 years of age or older
- full legal and mental capacity
- access to a smartphone (iOS and Android) with internet
Key exclusion criteria (2 listed)
- not fluent in English
- not able to read
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Current Personality Profile
Time frame: Single baseline measurement
Raw scores on each of dimensions of the Big Five Inventory
1 secondary outcome
Changes in Personality Profile
Time frame: Single baseline measurement
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Background: PubMed 34658861Kiraga MK, Mason NL, Uthaug MV, van Oorsouw KIM, Toennes SW, Ramaekers JG, Kuypers KPC. Persisting Effects of Ayahuasca on Empathy, Creative Thinking, Decentering, Personality, and Well-Being. Front Pharmacol. 2021 Oct 1;12:721537. doi: 10.3389/fphar.2021.721537. eCollection 2021.
- Background: PubMed 22905130Bouso JC, Gonzalez D, Fondevila S, Cutchet M, Fernandez X, Ribeiro Barbosa PC, Alcazar-Corcoles MA, Araujo WS, Barbanoj MJ, Fabregas JM, Riba J. Personality, psychopathology, life attitudes and neuropsychological performance among ritual users of Ayahuasca: a longitudinal study. PLoS One. 2012;7(8):e42421. doi: 10.1371/journal.pone.0042421. Epub 2012 Aug 8.
- Background: PubMed 25637267Bouso JC, Palhano-Fontes F, Rodriguez-Fornells A, Ribeiro S, Sanches R, Crippa JA, Hallak JE, de Araujo DB, Riba J. Long-term use of psychedelic drugs is associated with differences in brain structure and personality in humans. Eur Neuropsychopharmacol. 2015 Apr;25(4):483-92. doi: 10.1016/j.euroneuro.2015.01.008. Epub 2015 Jan 16.
- Background: PubMed 34349358Williams MT, Davis AK, Xin Y, Sepeda ND, Grigas PC, Sinnott S, Haeny AM. People of color in North America report improvements in racial trauma and mental health symptoms following psychedelic experiences. Drugs (Abingdon Engl). 2021;28(3):215-226. doi: 10.1080/09687637.2020.1854688. Epub 2020 Dec 10.
- Background: PubMed 26451760Martins SS, Sampson L, Cerda M, Galea S. Worldwide Prevalence and Trends in Unintentional Drug Overdose: A Systematic Review of the Literature. Am J Public Health. 2015 Nov;105(11):e29-49. doi: 10.2105/AJPH.2015.302843.
- Background: PubMed 19119355Harm reduction: An approach to reducing risky health behaviours in adolescents. Paediatr Child Health. 2008 Jan;13(1):53-60. doi: 10.1093/pch/13.1.53. No abstract available.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim PC Kuypers, PhD principal investigator
Maastricht University
Questions about this trial
What is this clinical trial studying?
An observational study of Personality, run by Quantified Citizen Technologies Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Current Personality Profile (time frame: Single baseline measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05180149, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.