NCT05180149

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).

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

December 17, 2021

Last Update Submit

April 23, 2022

Conditions

Keywords

PersonalitySubstance UsePsychedelicsDrugsChanges in Personality

Outcome Measures

Primary Outcomes (1)

  • Current Personality Profile

    Raw scores on each of dimensions of the Big Five Inventory

    Single baseline measurement

Secondary Outcomes (1)

  • Changes in Personality Profile

    Single baseline measurement

Study Arms (6)

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).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
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 (iOS and Android) with internet

You may not qualify if:

  • not fluent in English
  • not able to read

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 34658861BACKGROUND
  • Bouso 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.

    PMID: 22905130BACKGROUND
  • Bouso 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.

    PMID: 25637267BACKGROUND
  • Williams 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.

    PMID: 34349358BACKGROUND
  • Martins 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.

    PMID: 26451760BACKGROUND
  • Harm 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.

    PMID: 19119355BACKGROUND

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Kim PC Kuypers, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

December 17, 2021

First Posted

January 6, 2022

Study Start

April 1, 2022

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

April 29, 2022

Record last verified: 2022-04

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