Impact of Cannabis Consumption on Psychotic Symptoms and Reality Monitoring in Patients With Schizophrenia: a Real-life Study
NCT ID: NCT07309159
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2026-01-01
2028-12-31
Brief Summary
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Detailed Description
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Cannabis use is common among individuals with schizophrenia, with estimates suggesting that between 16% and 42% of patients have used cannabis at some point in their lives. The relationship between cannabis use and schizophrenia is multifactorial. Cannabis consumption has been associated with an increased risk of psychosis, worsening of positive symptoms, and earlier onset of the disorder. However, some studies indicate that cannabis may also exert beneficial effects on negative symptoms, potentially mediated by compounds other than THC.
Cognitive deficits are a core feature of schizophrenia, particularly impairments in reality monitoring. Reality monitoring refers to the ability to distinguish between internally generated events (intrinsic) and those originating from external sources (extrinsic). In schizophrenia, this capacity is often compromised, leading to misattributions of internal thoughts to external sources, which may contribute to the development of positive symptoms such as hallucinations.
Given the dynamic nature of symptoms and substance use in schizophrenia, traditional clinical models may fail to capture the complexity of these interactions. Ecological Momentary Assessment (EMA) provides a novel approach by leveraging mobile devices to collect real-time data on symptoms, substance use, and cognitive performance in everyday life. EMA has been validated in schizophrenia research, offering high-resolution data that can complement and enhance traditional models.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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"Cannabis user" group (SZ-CUD)
Use of Ecological Momentary Assessment (EMA) and a mobile Reality Monitoring task
Ecological Momentary Assessment (EMA) and Reality Monitoring tasks
Use of Ecological Momentary Assessment (EMA) and a mobile Reality Monitoring task
"Non-cannabis user" group (SZ-noCUD)
Use of Ecological Momentary Assessment (EMA) and a mobile Reality Monitoring task
Ecological Momentary Assessment (EMA) and Reality Monitoring tasks
Use of Ecological Momentary Assessment (EMA) and a mobile Reality Monitoring task
Interventions
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Ecological Momentary Assessment (EMA) and Reality Monitoring tasks
Use of Ecological Momentary Assessment (EMA) and a mobile Reality Monitoring task
Eligibility Criteria
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Inclusion Criteria
* Clinically stable and in the residual (non-acute) phase of illness,
* No change in antipsychotic treatment for at least 1 month,
* Outpatient, ambulatory care,
* No uncontrolled positive symptoms (assessed using PANSS)
* Patients able to use a mobile phone.
* Capacity and willingness to give informed consent.
* Must be able to read, speak, and understand French
* Patients subscribing to the French national medical insurance.
* Patients under "curatelle" (partial guardianship) are eligible
Exclusion Criteria
* Psychiatric comorbidities: autism, bipolar disorder.
* Current criteria for any other substance use disorder except for nicotine use disorder.
* Any medical condition hindering the study and/or use of the smartphone application.
* Patients with somatic, cognitive or other disorders preventing the use of the device (deafness, impaired vision, illiteracy….).
* Pregnant or breastfeeding woman.
* Patients who are not proficient in French.
* Subject included in clinical and/or therapeutic experimentation in progress.
18 Years
65 Years
ALL
No
Sponsors
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Centre Hospitalier Charles Perrens, Bordeaux
OTHER_GOV
Responsible Party
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Principal Investigators
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David MISDRAHI, MD
Role: STUDY_DIRECTOR
Centre Hospitalier Charles Perrens
Central Contacts
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References
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Argote M, Sescousse G, Brunelin J, Baudin G, Schaub MP, Rabin R, Schnell T, Ringen PA, Andreassen OA, Addington JM, Brambilla P, Delvecchio G, Bechdolf A, Wobrock T, Schneider-Axmann T, Herzig D, Mohr C, Vila-Badia R, Rodie JU, Mallet J, Ricci V, Martinotti G, Knizkova K, Rodriguez M, Cookey J, Tibbo P, Scheffler F, Asmal L, Garcia-Rizo C, Amoretti S, Huber C, Thibeau H, Kline E, Fakra E, Jardri R, Nourredine M, Rolland B. Association between cannabis use and symptom dimensions in schizophrenia spectrum disorders: an individual participant data meta-analysis on 3053 individuals. EClinicalMedicine. 2023 Sep 8;64:102199. doi: 10.1016/j.eclinm.2023.102199. eCollection 2023 Oct.
Addington J, Addington D. Patterns, predictors and impact of substance use in early psychosis: a longitudinal study. Acta Psychiatr Scand. 2007 Apr;115(4):304-9. doi: 10.1111/j.1600-0447.2006.00900.x.
Abdel-Baki A, Lal S, D-Charron O, Stip E, Kara N. Understanding access and use of technology among youth with first-episode psychosis to inform the development of technology-enabled therapeutic interventions. Early Interv Psychiatry. 2017 Feb;11(1):72-76. doi: 10.1111/eip.12250. Epub 2015 May 22.
Other Identifiers
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2025-A01055-44
Identifier Type: -
Identifier Source: org_study_id