PsychosisPhase 4NCT07001878
Cannabis Potency Effects on Brain White Matter in Early Phase Psychosis
A Phase 4 study testing Metformin in people with Psychosis and Cannabis Use, run by Nova Scotia Health Authority at 2 sites in Canada.
Trial summary
Canada reports some of the highest rates of cannabis use in our youth and young adult populations, among all the developed countries. Recent Health Canada surveys report that 27% of 16-19-year-olds and 32% of 20-24-year-olds have used cannabis in the past 30 days, with 16-24-year-olds showing the highest rates of… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Psychosis, Cannabis Use
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesCanada
- Study dates
- 18 Mar 2025to 1 Dec 2026
- Phase
- Phase 4
- 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- This study will enroll individuals 18-25 years of age from the Nova Scotia Early Psychosis Program
Who cannot join
- Current stimulant use disorder
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Nova Scotia Early Psychosis Program
Halifax, Nova Scotia
- Recruiting
Psychosis Intervention Early Recovery Program
St. John's, Newfoundland and Labrador
About this study
Official title: Cannabis Potency Effects on Brain White Matter in Early Phase Psychosis: A Pilot Feasibility Treatment Study
Canada reports some of the highest rates of cannabis use in our youth and young adult populations, among all the developed countries. Recent Health Canada surveys report that 27% of 16-19-year-olds and 32% of 20-24-year-olds have used cannabis in the past 30 days, with 16-24-year-olds showing the highest rates of daily or near-daily use. Unfortunately, cannabis use has also been found to be a risk factor for the development of a psychotic disorder in emerging adults, and in those who develop psychosis and continue cannabis use, there is a significant effect on long term outcomes. This includes the severity of symptoms, risks of relapse (being hospitalized) and not reaching a level of functioning that would be expected. Lifetime experience with cannabis is greater than 80% in young adults with early phase psychosis (EPP; the first 5 years of a psychosis illness) with up to 30% of Canadian EPP patients meeting criteria for a diagnosis of cannabis use disorder (CUD) at entry to care. A recent Canadian population-based study found that cannabis use disorder associated to psychosis has risen from 3.7% pre-2018 to 10.3% at present. There has been a significant increase in Δ9-tetrahydrocannabinol (THC) levels in cannabis products available globally over the years, with popular cannabis products available start as high as 18% THC in Canada. However high potency cannabis carries a more significant risk for psychosis development, as well as higher risk for cannabis dependence and other severe mental health issues.
A major gap in the research is a specific focus on cannabis potency on brain white matter (WM) in youth and young adults, and if there are any potential treatment strategies that could be used to influence any of these cannabis WM effects. To address this, a medication called metformin, that is already used in psychosis to help with side effects of antipsychotic medications, will be used as it has also shown promise to influence WM changes in other illnesses. This project is thus focused on naturalistic cannabis potency effects on WM in emerging adults in EPP (divided into three groups; those using high potency cannabis, low potency cannabis, and minimal cannabis use) and treating them with metformin for 6 months and assessing effects on neuroimaging, cognitive and clinical variables.
Read more
The purpose of this pilot feasibility study is to inform the development/refinement of an intervention protocol, and not to test potential effects or mechanisms as the sample size will have insufficient power to perform an in-depth analysis. The results of this work will inform our research strategy development and assess feasibility of our novel methodological approach.
Participants will:
- Visit the clinic at baseline, 3 months (only Timeline Follow-Back Assessment administered), and 6 months post baseline to complete substance use and mental health questionnaires, and cognitive assessments
- Complete an MRI scan at baseline and 6 months
- Take Metformin every day for 6 months
Read the detailed description
Researchers will compare three groups of young adults with EPP: those using cannabis on a regular basis i) high potency (>15% THC) and ii) low potency (<15% THC) cannabis products and iii) patients with minimal-to-no cannabis use to see if there are differences in cannabis potency effects on white matter.
This study will collect four different types of variables: demographic (things that describe the participants), clinical (things that describe how ill the individuals are), substance use (things that measure how much or how reliant participants are on recreational substances), and neuropsychological (things that measure cognitive functioning such as attention, memory, verbal learning, and executive functioning).
Baseline demographics will include age, sex, gender and ethnicity. The Timeline Followback (TLFB) method will be used to collect detailed information about current cannabis use, which includes quantity, frequency, and potency (e.g., THC %, THC/CBD). Potency data will be self-report, verified whenever possible through the use of the Nova Scotia Liquor Corporation product website and other websites used for product purchase. Cannabis quantity and frequency will be assisted by visual aids. The TLFB has been validated for use among those with schizophrenia-spectrum disorders. The World Health Organization - Alcohol, Smoking, and Substance Involvement Screening Test (WHO-ASSIST) will be used to collect non-cannabis substance use data and the Cannabis Use Disorder Identification Test - Revised (CUDIT-R) will be used to measure problematic cannabis use. Overall psychosis symptoms will be measured by the Clinical Global Impression scale, for both severity and improvement (CGI-S, CGI-I). Cognitive data will be collected, focusing on tasks that are known to be affected by cannabis use (including high potency product). These include verbal learning and memory (California Verbal Learning Test-3; CVLT-3) and executive functioning (Trail Making Test B; TMT-B). In addition, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be used which includes domains of immediate memory, language, attention, and delayed memory.
Neuroimaging: Subjects will undergo a Magnetic Resonance Imaging (MRI) scan collecting T1-weighted structural, diffusion-weighted scans and magnetic resonance spectroscopy data at baseline and 6 months post baseline.
Interim and final assessments: The TLFB will be completed 3 months post baseline. At 6-months post baseline, all the above measures and imaging will be repeated (study end).
- Conditions
- Psychosis, Cannabis Use
- Being tested
- Metformin
- Keywords
- cannabis, metformin, early phase psychosis, potency
- Medical subject headings
- Psychotic Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage, Metformin Hydrochloride
Metformin will be prescribed, reaching 1000mg/day (a standard dose). This will be done under the principal investigator's care and the patient's clinical team, including assessment of metformin adherence. Metformin will be prescribed for 6 months. Antipsychotic treatment will continue as per standard of care (metformin as adjunct therapy), as well as routine follow up.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | All participants will receive 6 months of daily Metformin treatment and attend baseline, 3 months, and 6 months post baseline appointments. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cannabis use
Cannabis Timeline Followback (TLFB) is a retrospective past 30 day calendar method used to collect detailed information about current cannabis use, which includes quantity, method of use (e.g. dried cannabis smoked, concentrate vaped, edibles, etc.), frequency, strain, and potency (e.g., THC %, THC/CBD).
Measured: Baseline, 3 months, 6 months
Treatment adherence
The difference between the number of participants who completed 6 months of Metformin treatment compared to those who ceased using medication prior to study end at 6 months.
Measured: Baseline to 6 months
Change in white matter microstructure
Changes from baseline to study end at 6 months in study completers using Orientation dispersion index values from Neurite orientation dispersion and density imaging (NODDI).
Measured: Baseline to 6 Months
Change in glial cell marker
Measurement of glial cell marker neurochemical in the dorsomedial prefrontal region of brain Myo-inositol level changes from baseline to study end at 6 months for study completers using Magnetic resonance spectroscopy (MRS).
Measured: Baseline to 6 months
Recruitment success
The difference between the number of patients approached about the opportunity to participate and the total number of participants enrolled in the study for each study cohort.
Measured: Baseline
Secondary outcomes (8)
Change in white matter to grey matter ratio
Changes from baseline in percent whole brain gray and white matter at 6 months assessed with MPRAGE imaging.
Measured: Baseline to 6 months
Change in inflammatory neurochemicals
Measurement of inflammatory neurochemical changes in the dorsomedial prefrontal region of brain by measurement of total choline level changes in dorsomedial prefrontal region of the brain from baseline to 6 months using Magnetic resonance spectroscopy (MRS).
Measured: Baseline to 6 months
Change in overall substance use
The WHO Alcohol, Smoking, and Substance Involvement Screening Test (WHO-ASSIST) will measure substance use risk scores to account for problematic use other than cannabis use from baseline to 6 months. Scores range from 0-39 for each substance with higher scores indicating more severe risk associated with use.
Measured: Baseline to 6 months
Changes in problematic cannabis use
Cannabis Use Disorder Identification Test - Revised (CUDIT-R) will be used to measure problematic cannabis use scores from baseline to 6 months on a scale of 0-32 with higher scores indicating more problematic use.
Measured: Baseline to 6 months
Change in severity of illness
Clinical Global Impression Scale - Severity (CGI-S) at baseline and then the complementary scale for follow-up the Clinical Global Impression Scale - Improvement (CGI-I) will measure changes from baseline in participants overall illness severity at 6 months, The CGI-S, a 7-point clinician rated Likert scale that measures individuals' overall illness severity relative those who the clinician has experienced with the same diagnosis (ranging from 1 = Normal, not at all ill to 7 = Extremely ill). The CGI-I is based on the CGI-S rating and is a 7-point clinician rated Likert scale ranging from 1 = Very much improved to 7 = Very much worse.
Measured: Baseline to 6 months
Changes in verbal learning
The California Verbal Learning Test - Third Edition (CVLT3) will be used to measure changes in verbal learning index scores from baseline to 6 months. The CVLT3 measures episodic verbal learning including verbal learning, immediate memory, and delayed memory. The CVLT3 yields three index scores of overall verbal learning and memory performance using a mean of 100 and a standard deviation (SD) of 15 points. The scores range from 40-160, which is 4 SDs below and above the mean.
Measured: Baseline to 6 months
Changes in executive functioning
Trail Making Test B (TMT-B) will be used to measure changes in recorded time taken to complete the task from baseline to 6 months. The assessment requires participant to draw a continuous line between circles containing letters and numbers in the correct ascending sequence (i.e., 1-A-2-B-3-C, etc.). Recorded test time more than 180 seconds indicates deficits in executive functioning.
Measured: Baseline to 6 months
Changes in overall cognitive functioning
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be used to measure changes in global cognition from baseline to 6 months. The RBANS is a comprehensive neuropsychological battery for the evaluation of global cognition and has been validated in subjects with schizophrenia. It includes measures of immediate and delayed memory, attention, visuospatial construction, and language. Scores range from 0 to 160 with 100 representing the population average. Higher scores represent better cognition.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start18 Mar 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Principal investigator, Phil Tibbo, Nova Scotia Health Authority
- Investigators
- Philip G Tibbo, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001878
- Sponsor's protocol ID
- 73219
- Status last verified
- Apr 2026
- First submitted
- 7 May 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical and privacy considerations outlined by the Nova Scotia Health Authority. Data sharing was not a requirement of the study's funding, and given the small sample size, there is a heightened risk of re-identification of participants. To protect participant confidentiality and adhere to institutional ethics guidelines, data will remain securely stored and will not be made available to external parties.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis Potency Effects on Brain White Matter in Early Phase Psychosis: A Pilot Feasibility Treatment Study
- ClinicalTrials.gov ID
- NCT07001878
- Acronym / sponsor ID
- 73219
- Conditions
- Psychosis, Cannabis Use
- Keywords
- cannabis, metformin, early phase psychosis, potency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Jun 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.
Canada reports some of the highest rates of cannabis use in our youth and young adult populations, among all the developed countries. Recent Health Canada surveys report that 27% of 16-19-year-olds and 32% of 20-24-year-olds have used cannabis in the past 30 days, with 16-24-year-olds showing the highest rates of daily or near-daily use. Unfortunately, cannabis use has also been found to be a risk factor for the development of a psychotic disorder in emerging adults, and in those who develop psychosis and continue cannabis use, there is a significant effect on long term outcomes. This includes the severity of symptoms, risks of relapse (being hospitalized) and not reaching a level of functioning that would be expected. Lifetime experience with cannabis is greater than 80% in young adults with early phase psychosis (EPP; the first 5 years of a psychosis illness) with up to 30% of Canadian EPP patients meeting criteria for a diagnosis of cannabis use disorder (CUD) at entry to care. A recent Canadian population-based study found that cannabis use disorder associated to psychosis has risen from 3.7% pre-2018 to 10.3% at present. There has been a significant increase in Δ9-tetrahydrocannabinol (THC) levels in cannabis products available globally over the years, with popular cannabis products available start as high as 18% THC in Canada. However high potency cannabis carries a more significant risk for psychosis development, as well as higher risk for cannabis dependence and other severe mental health issues.
A major gap in the research is a specific focus on cannabis potency on brain white matter (WM) in youth and young adults, and if there are any potential treatment strategies that could be used to influence any of these cannabis WM effects. To address this, a medication called metformin, that is already used in psychosis to help with side effects of antipsychotic medications, will be used as it has also shown promise to influence WM changes in other illnesses. This project is thus focused on naturalistic cannabis potency effects on WM in emerging adults in EPP (divided into three groups; those using high potency cannabis, low potency cannabis, and minimal cannabis use) and treating them with metformin for 6 months and assessing effects on neuroimaging, cognitive and clinical variables.
The purpose of this pilot feasibility study is to inform the development/refinement of an intervention protocol, and not to test potential effects or mechanisms as the sample size will have insufficient power to perform an in-depth analysis. The results of this work will inform our research strategy development and assess feasibility of our novel methodological approach.
Participants will:
- Visit the clinic at baseline, 3 months (only Timeline Follow-Back Assessment administered), and 6 months post baseline to complete substance use and mental health questionnaires, and cognitive assessments
- Complete an MRI scan at baseline and 6 months
- Take Metformin every day for 6 months
Detailed description
Researchers will compare three groups of young adults with EPP: those using cannabis on a regular basis i) high potency (>15% THC) and ii) low potency (<15% THC) cannabis products and iii) patients with minimal-to-no cannabis use to see if there are differences in cannabis potency effects on white matter.
This study will collect four different types of variables: demographic (things that describe the participants), clinical (things that describe how ill the individuals are), substance use (things that measure how much or how reliant participants are on recreational substances), and neuropsychological (things that measure cognitive functioning such as attention, memory, verbal learning, and executive functioning).
Baseline demographics will include age, sex, gender and ethnicity. The Timeline Followback (TLFB) method will be used to collect detailed information about current cannabis use, which includes quantity, frequency, and potency (e.g., THC %, THC/CBD). Potency data will be self-report, verified whenever possible through the use of the Nova Scotia Liquor Corporation product website and other websites used for product purchase. Cannabis quantity and frequency will be assisted by visual aids. The TLFB has been validated for use among those with schizophrenia-spectrum disorders. The World Health Organization - Alcohol, Smoking, and Substance Involvement Screening Test (WHO-ASSIST) will be used to collect non-cannabis substance use data and the Cannabis Use Disorder Identification Test - Revised (CUDIT-R) will be used to measure problematic cannabis use. Overall psychosis symptoms will be measured by the Clinical Global Impression scale, for both severity and improvement (CGI-S, CGI-I). Cognitive data will be collected, focusing on tasks that are known to be affected by cannabis use (including high potency product). These include verbal learning and memory (California Verbal Learning Test-3; CVLT-3) and executive functioning (Trail Making Test B; TMT-B). In addition, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be used which includes domains of immediate memory, language, attention, and delayed memory.
Neuroimaging: Subjects will undergo a Magnetic Resonance Imaging (MRI) scan collecting T1-weighted structural, diffusion-weighted scans and magnetic resonance spectroscopy data at baseline and 6 months post baseline.
Interim and final assessments: The TLFB will be completed 3 months post baseline. At 6-months post baseline, all the above measures and imaging will be repeated (study end).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminAll participants will receive 6 months of daily Metformin treatment and attend baseline, 3 months, and 6 months post baseline appointments. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- This study will enroll individuals 18-25 years of age from the Nova Scotia Early Psychosis Program
Key exclusion criteria (1 listed)
- Current stimulant use disorder
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 |
|---|---|---|
| MetforminAlso: Glucophage, Metformin HydrochlorideMetformin will be prescribed, reaching 1000mg/day (a standard dose). This will be done under the principal investigator's care and the patient's clinical team, including assessment of metformin adherence. Metformin will be prescribed for 6 months. Antipsychotic treatment will continue as per standard of care (metformin as adjunct therapy), as well as routine follow up. | Drug | Metformin |
Primary outcome
Change in cannabis use
Time frame: Baseline, 3 months, 6 months
Cannabis Timeline Followback (TLFB) is a retrospective past 30 day calendar method used to collect detailed information about current cannabis use, which includes quantity, method of use (e.g. dried cannabis smoked, concentrate vaped, edibles, etc.), frequency, strain, and potency (e.g., THC %, THC/CBD).
Treatment adherence
Time frame: Baseline to 6 months
The difference between the number of participants who completed 6 months of Metformin treatment compared to those who ceased using medication prior to study end at 6 months.
Change in white matter microstructure
Time frame: Baseline to 6 Months
Changes from baseline to study end at 6 months in study completers using Orientation dispersion index values from Neurite orientation dispersion and density imaging (NODDI).
Change in glial cell marker
Time frame: Baseline to 6 months
Measurement of glial cell marker neurochemical in the dorsomedial prefrontal region of brain Myo-inositol level changes from baseline to study end at 6 months for study completers using Magnetic resonance spectroscopy (MRS).
Recruitment success
Time frame: Baseline
The difference between the number of patients approached about the opportunity to participate and the total number of participants enrolled in the study for each study cohort.
8 secondary outcomes
Change in white matter to grey matter ratio
Time frame: Baseline to 6 months
Change in inflammatory neurochemicals
Time frame: Baseline to 6 months
Change in overall substance use
Time frame: Baseline to 6 months
Changes in problematic cannabis use
Time frame: Baseline to 6 months
Change in severity of illness
Time frame: Baseline to 6 months
Changes in verbal learning
Time frame: Baseline to 6 months
Changes in executive functioning
Time frame: Baseline to 6 months
Changes in overall cognitive functioning
Time frame: Baseline to 6 months
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 7 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical and privacy considerations outlined by the Nova Scotia Health Authority. Data sharing was not a requirement of the study's funding, and given the small sample size, there is a heightened risk of re-identification of participants. To protect participant confidentiality and adhere to institutional ethics guidelines, data will remain securely stored and will not be made available to external parties.
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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.
Philip G Tibbo, MD principal investigator
Nova Scotia Health Authority
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with Psychosis and Cannabis Use, run by Nova Scotia Health Authority at 2 sites in Canada.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Rachel Church, MSc.OT (902-473-7474, rachel.church@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cannabis use (time frame: Baseline, 3 months, 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.