SchizophreniaPhase 1/2F_r_IEND-3NCT07309159
Impact of Cannabis Consumption on Psychotic Symptoms and Reality Monitoring in Patients With Schizophrenia: a Real-life Study
A Phase 1/2 study testing Ecological Momentary Assessment (EMA) and Reality Monitoring tasks in people with Schizophrenia, run by Centre Hospitalier Charles Perrens, Bordeaux.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Ecological Momentary Assessment (EMA) and Reality Monitoring tasks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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
- Schizophrenia
- Being tested
- Ecological Momentary Assessment (EMA) and Reality Monitoring tasks
- Keywords
- cannabis, schizophrenia, EMA, reality monitoring
- Medical subject headings
- Schizophrenia, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological Momentary Assessment (EMA) and Reality Monitoring tasksOther
Use of Ecological Momentary Assessment (EMA) and a mobile Reality Monitoring task
| Study group | Role | What they receive |
|---|---|---|
| "Cannabis user" group (SZ-CUD) | Experimental | Use of Ecological Momentary Assessment (EMA) and a mobile Reality Monitoring task Receives: 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 Receives: Other: Ecological Momentary Assessment (EMA) and Reality Monitoring tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- "Cannabis user" group (SZ-CUD) "Non-cannabis user" group (SZ-noCUD)
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Charles Perrens, Bordeaux
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- David MISDRAHI, MD, Study director, Centre Hospitalier Charles Perrens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309159
- Sponsor's protocol ID
- 2025-A01055-44
- Acronym
- F_r_IEND-3
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37731936Addington 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.
PubMed 17355521Abdel-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.
PubMed 26011657
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cannabis Consumption on Psychotic Symptoms and Reality Monitoring in Patients With Schizophrenia: a Real-life Study
- ClinicalTrials.gov ID
- NCT07309159
- Acronym / sponsor ID
- F_r_IEND-3 / 2025-A01055-44
- Conditions
- Schizophrenia
- Keywords
- cannabis, schizophrenia, EMA, reality monitoring
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Charles Perrens, BordeauxOther government
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- "Cannabis user" group (SZ-CUD) "Non-cannabis user" group (SZ-noCUD)
| Arm | Type | Receives |
|---|---|---|
| "Cannabis user" group (SZ-CUD) | Experimental | Other: Ecological Momentary Assessment (EMA) and Reality Monitoring tasksUse of Ecological Momentary Assessment (EMA) and a mobile Reality Monitoring task |
| "Non-cannabis user" group (SZ-noCUD) | Active comparator | Other: Ecological Momentary Assessment (EMA) and Reality Monitoring tasksUse of Ecological Momentary Assessment (EMA) and a mobile Reality Monitoring task |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- DSM-5 diagnosis of schizophrenia or schizo-affective disorder with the following clinical features:
- 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.
Key exclusion criteria (8 listed)
- 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….).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecological Momentary Assessment (EMA) and Reality Monitoring tasksUse of Ecological Momentary Assessment (EMA) and a mobile Reality Monitoring task | Other | "Cannabis user" group (SZ-CUD), "Non-cannabis user" group (SZ-noCUD) |
Primary outcome
Presence of a statistically significant association between cannabis consumption and the reduction of negative symptoms
Time frame: 8 days
Presence of a statistically significant association between cannabis consumption and the exacerbation of positive symptoms with EMA scale
Presence of a statistically significant association between cannabis consumption and the exacerbation of positive symptoms
Time frame: 8 days
Presence of a statistically significant association between cannabis consumption and the reduction of negative symptoms with EMA scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Results publication: PubMed 37731936Argote 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.
- Results publication: PubMed 17355521Addington 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.
- Results publication: PubMed 26011657Abdel-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David MISDRAHI, MD study director
Centre Hospitalier Charles Perrens
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ecological Momentary Assessment (EMA) and Reality Monitoring tasks in people with Schizophrenia, run by Centre Hospitalier Charles Perrens, Bordeaux.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David MISDRAHI, MD (+33 (0)5 56 56 34 49, dmisdrahi@ch-perrens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a statistically significant association between cannabis consumption and the reduction of negative symptoms (time frame: 8 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07309159, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.