No Conditions Study Focus on Substance Use and PersonalityPDUNCT05516823
Personality and Drug Use
An observational study of No Conditions Study Focus on Substance Use and Personality, run by Psychedelic Data Society.
Trial summary
This is an observational, naturalistic study that aims to assess whether people with different histories of recreational or therapeutic illicit substance use (or no history at all) will differ in terms of their personalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- No Conditions Study Focus on Substance Use and Personality
- What is being tested?
- Usage of drugs
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Nov 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
- 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 with internet to fill in the study measures (available for iOS and Android)
Who cannot join
- lack of proficiency in English
- visual impairments (not able to use mobile devices)
- illiteracy
Trial locations and contacts
No sites are listed yet.
Kim PC Kuypers, PhD contact
About this study
This is an observational, naturalistic study that aims to assess whether people with different histories of recreational or therapeutic illicit substance use (or no history at all) will differ in terms of their personalities.
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 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.
- Being tested
- Usage of drugs
- Keywords
- personality, substance use, psychedelics, drugs
- 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.
Usage of drugsOther
Self-reported past usage of drugs belonging to different chemical groups.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Usage of drugs | |
| 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) Receives: Other: Usage of drugs | |
| 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 Receives: Other: Usage of drugs | |
| 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) Receives: Other: Usage of drugs | |
| 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 Receives: Other: Usage of drugs | |
| 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.
Change in scores on Big Five Inventory (BFI-44)
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: 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 outcomes (1)
Change in scores on Retrospective Personality Scale (RPS)
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: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study startNov 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Conditions Study Focus on Substance Use and 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psychedelic Data Society
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, Quantified Citizen Technologies Inc.
- Responsible party
- Sponsor
- Investigators
- Kim PC Kuypers, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516823
- Sponsor's protocol ID
- 21017 Personality and Drug Use
- Acronym
- PDU
- Status last verified
- Aug 2022
- First submitted
- 18 Jul 2022
- Last updated
- 28 Sep 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personality and Drug Use
- ClinicalTrials.gov ID
- NCT05516823
- Acronym / sponsor ID
- PDU / 21017 Personality and Drug Use
- Keywords
- personality, substance use, psychedelics, drugs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Psychedelic Data SocietyUniversity, hospital or other
- Collaborators
- Maastricht University, Quantified Citizen Technologies Inc.
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 26 Aug 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.
This is an observational, naturalistic study that aims to assess whether people with different histories of recreational or therapeutic illicit substance use (or no history at all) will differ in terms of their personalities.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group: Psychedelics-only Group | – | Other: Usage of drugsA 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) |
| Group: Stimulants-only Group | – | Other: Usage of drugsA 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 | – | Other: Usage of drugsA 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 | – | Other: Usage of drugsA 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 | – | Other: Usage of drugsA 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 |
| 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
- 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 with internet to fill in the study measures (available for iOS and Android)
Key exclusion criteria (3 listed)
- lack of proficiency in English
- visual impairments (not able to use mobile devices)
- illiteracy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usage of drugsSelf-reported past usage of drugs belonging to different chemical groups. | Other | Cannabinoids Group, Depressants-only Group, Group: Psychedelics-only Group, Group: Stimulants-only Group, Psychedelic and Non-psychedelic Substances Group |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- 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.
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 contact
Kim PC Kuypers, PhD principal investigator
Maastricht University
Questions about this trial
What is this clinical trial studying?
An observational study of No Conditions Study Focus on Substance Use and Personality, run by Psychedelic Data Society.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maggie K Kiraga, MSc (4373249251 ext. 001, maggie@quantifiedcitizen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2022.