Impact of Cannabis Consumption on Psychotic Symptoms and Reality Monitoring in Patients With Schizophrenia: a Real-life Study

NCT07309159 | Not Yet Recruiting Phase 1

• 1 other identifier: 2025-A01055-44
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Schizophrenia

Keywords

cannabis; schizophrenia; EMA; reality monitoring

Outcome Measures

Primary Outcomes (2)

• Presence of a statistically significant association between cannabis consumption and the reduction of negative symptoms

  Presence of a statistically significant association between cannabis consumption and the exacerbation of positive symptoms with EMA scale

  8 days

• Presence of a statistically significant association between cannabis consumption and the exacerbation of positive symptoms

  Presence of a statistically significant association between cannabis consumption and the reduction of negative symptoms with EMA scale

  8 days

Study Arms (2)

"Cannabis user" group (SZ-CUD)

EXPERIMENTAL

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

Other: Ecological Momentary Assessment (EMA) and Reality Monitoring tasks

"Non-cannabis user" group (SZ-noCUD)

ACTIVE COMPARATOR

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

Other: Ecological Momentary Assessment (EMA) and Reality Monitoring tasks

Interventions

Ecological Momentary Assessment (EMA) and Reality Monitoring tasks OTHER

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

"Cannabis user" group (SZ-CUD); "Non-cannabis user" group (SZ-noCUD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Charles Perrens, Bordeaux: lead

Related Publications (3)

• 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.

  PMID: 37731936 RESULT

• 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.

  PMID: 17355521 RESULT

• 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.

  PMID: 26011657 RESULT

MeSH Terms

Conditions

Schizophrenia; Marijuana Abuse

Interventions

Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• David MISDRAHI, MD

  Centre Hospitalier Charles Perrens

  STUDY DIRECTOR

Central Study Contacts

David MISDRAHI, MD

CONTACT

+33 (0)5 56 56 34 49; dmisdrahi@ch-perrens.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: "Cannabis user" group (SZ-CUD) "Non-cannabis user" group (SZ-noCUD)

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 30, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03