NCT05516823

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

September 28, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

July 18, 2022

Last Update Submit

September 27, 2022

Conditions

Keywords

personalitysubstance usepsychedelicsdrugs

Outcome Measures

Primary Outcomes (1)

  • 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 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)

    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.

Study Arms (6)

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)

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)

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

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)

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

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).

Interventions

Self-reported past usage of drugs belonging to different chemical groups.

Cannabinoids GroupDepressants-only GroupGroup: Psychedelics-only GroupGroup: Stimulants-only GroupPsychedelic and Non-psychedelic Substances Group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • lack of proficiency in English
  • visual impairments (not able to use mobile devices)
  • illiteracy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Kim PC Kuypers, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maggie K Kiraga, MSc

CONTACT

Kim PC Kuypers, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2022

First Posted

August 26, 2022

Study Start

November 1, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

September 28, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, 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
More information