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Understanding the Influence of Cannabis on the Predictive Mind: A Multimodal Computational Study

Understanding the Influence of Cannabis on the Predictive Mind: A Multimodal Computational Study - CANNABODIES

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57671
Enrollment
220
Registered
2024-10-30
Start date
2025-01-10
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Not applicable

Interventions

Participants will receive two doses of cannabis (100 µg THC/kg bodyweight and&nbsp
200 µg THC/kg bodyweight), and one dose of placebo on separate testing days.

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Used cannabis between 1 time a month and 2 times a week during the previous year Age between 18 and 40 years Free from psychotropic medication Good physical health as determined by medical examination and laboratory analysis Absence of any major psychiatric, endocrine and neurological condition as determined by medical examination and laboratory analysis Normal weight, body mass index (weight/height2) between 18 and 28 kg/m2 Written Informed Consent Good knowledge and understanding of the English language Participants must be willing to refrain from taking illicit psychoactive substances during the study. Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drinks after midnight of the evening before the study session, as well as during the study day. Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after substance administration.

Exclusion criteria

Exclusion criteria: History of drug addiction (determined by the medical questionnaire, drug  questionnaire and medical examination) Pregnancy or lactation or pregnancy planned during study participation Hypertension (diastolic > 90 mmHg; systolic > 140 mmHg) Current or history of psychiatric disorder (determined by the medical  questionnaire and medical examination) Current presence or history of psychosis in first-degree relatives History of cardiac dysfunctions (arrhythmia, ischemic heart disease,*) Excessive tobacco smoking (>20 per day) Excessive drinking (>20 alcoholic consumptions per week) For women: no use of a reliable contraceptive

Design outcomes

Primary

MeasureTime frame
Overall Primary Objective: Across all 4 arms, we will identify whether THC alters cardiac or respiratory interoception, and whether individual differences in these effects mediate the acute effects of THC on task and subjective measures. Arm Specific Primary Objectives: Assess how THC influences cognitive learning mechanisms across 4 primary domains: Effort and Motivation (Arm 1), Pain and Thermosensation (Arm 2), Reward and Affect (Arm 3):, Breath Awareness and Dyspnea (Arm 4).

Secondary

MeasureTime frame
Secondary Objectives: Assess the influence of THC on pharmacodynamics, inflammatory markers, and the correlation of these effects with the cognitive, interoceptive, and affective markers in the primary objectives.

Countries

Netherlands

Contacts

Public ContactEL Theunissen

Universiteit Maastricht

e.theunissen@maastrichtuniversity.nl0433881940

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)