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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-12-31

Brief Summary

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This study aims to examine the dual effects of cannabis consumption on both positive and negative symptoms of schizophrenia, across laboratory and real-world contexts. By integrating ecological momentary assessment (EMA) with cognitive tasks such as reality monitoring, the research seeks to clarify how cannabis use influences symptom severity and cognitive functioning in individuals with schizophrenia. Gaining insight into these relationships may contribute to the development of more effective management strategies and ultimately improve outcomes for patients living with schizophrenia.

Detailed Description

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Schizophrenia is a complex psychiatric disorder that affects approximately 1% of the general population, typically emerging in early adulthood. It is characterized by a wide range of symptoms, including positive symptoms (e.g., hallucinations and delusions), negative symptoms (e.g., apathy and emotional blunting), and cognitive impairments. The disorder contributes substantially to the global burden of disease, ranking among the top 30 causes of disability-adjusted life years.

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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Schizophrenia

Keywords

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cannabis schizophrenia EMA reality monitoring

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

"Cannabis user" group (SZ-CUD) "Non-cannabis user" group (SZ-noCUD)
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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"Cannabis user" group (SZ-CUD)

Use of Ecological Momentary Assessment (EMA) and a mobile Reality Monitoring task

Group Type EXPERIMENTAL

Ecological Momentary Assessment (EMA) and Reality Monitoring tasks

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Ecological Momentary Assessment (EMA) and Reality Monitoring tasks

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* DSM-5 diagnosis of schizophrenia or schizo-affective disorder with the following clinical features:

* 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

Patient under "tutelle" (full legal guardianship).

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Charles Perrens, Bordeaux

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David MISDRAHI, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Charles Perrens

Central Contacts

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David MISDRAHI, MD

Role: CONTACT

Phone: +33 (0)5 56 56 34 49

Email: [email protected]

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.

Reference Type RESULT
PMID: 37731936 (View on PubMed)

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.

Reference Type RESULT
PMID: 17355521 (View on PubMed)

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.

Reference Type RESULT
PMID: 26011657 (View on PubMed)

Other Identifiers

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2025-A01055-44

Identifier Type: -

Identifier Source: org_study_id