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Personality and Drug Use (PDU) (PDU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05180149
Recruitment Status : Withdrawn (The sponsor of the study has changed.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.)
First Posted : January 6, 2022
Last Update Posted : April 29, 2022
Sponsor:
Collaborators:
Maastricht University
Psychedelic Data Society
Information provided by (Responsible Party):
Maggie Kiraga, Maastricht University

Tracking Information
First Submitted Date December 17, 2021
First Posted Date January 6, 2022
Last Update Posted Date April 29, 2022
Estimated Study Start Date April 2022
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2021)
Current Personality Profile [ Time Frame: Single baseline measurement ]
Raw scores on each of dimensions of the Big Five Inventory
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 17, 2021)
Changes in Personality Profile [ Time Frame: Single baseline measurement ]
Raw scores on the positive and negative dimensions of the self-constructed (for the study needs) Retrospective Personality Scale
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Personality and Drug Use (PDU)
Official Title Personality and Drug Use (PDU)
Brief 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).
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults (age of 18 or above) of full mental and legal capacities.
Condition Personality
Intervention Not Provided
Study Groups/Cohorts
  • 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).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: April 23, 2022)
0
Original Estimated Enrollment
 (submitted: December 17, 2021)
1000
Estimated Study Completion Date April 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT05180149
Other Study ID Numbers QCPUBLICPDU1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: The raw data and clinical study report will be made available within 12 months from the end date of data collection.
Access Criteria: Open access
Current Responsible Party Maggie Kiraga, Maastricht University
Original Responsible Party Quantified Citizen Technologies Inc.
Current Study Sponsor Quantified Citizen Technologies Inc.
Original Study Sponsor Same as current
Collaborators
  • Maastricht University
  • Psychedelic Data Society
Investigators
Principal Investigator: Kim PC Kuypers, PhD Maastricht University
PRS Account Quantified Citizen Technologies Inc.
Verification Date April 2022