24 Participants NeededMy employer runs this trial

Metformin for Cannabis Use and Psychosis

Recruiting at 1 trial location
CE
RC
Overseen ByRachel Church, MSc.OT
Age: 18 - 65
Sex: Any
Trial Phase: Phase 4
Sponsor: Nova Scotia Health Authority
Must be taking: Metformin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how metformin might assist young adults with early-phase psychosis who use cannabis, particularly high-potency cannabis. Researchers aim to determine if metformin can affect changes in the brain's white matter, which facilitates communication between different brain regions and is impacted by cannabis use. Participants will take metformin daily for six months, undergo brain scans, and complete mental health and cognitive assessments. The trial seeks individuals aged 18-25 from the Nova Scotia Early Psychosis Program who do not have a current stimulant use disorder. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.

What is the safety track record for Metformin?

Research shows that people generally tolerate metformin well, and it has been safely used for a long time. Since the late 1950s, it has treated type 2 diabetes and remains popular today, with about 150 million people taking it daily. Studies have found that metformin helps control blood sugar levels without causing major side effects, making it safe for long-term use.

Further research indicates that metformin has few side effects and is safe for extended treatment. In studies with young people who have prediabetes, metformin improved blood sugar levels without major safety issues. Overall, its widespread use and safety make metformin a dependable treatment option.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatment options for cannabis use and psychosis, which often include antipsychotics and behavioral therapies, Metformin is unique because it is primarily known as a diabetes medication. Researchers are excited about Metformin because it targets metabolic pathways rather than the brain's neurotransmitter systems, offering a fresh approach to managing symptoms. This could potentially lead to fewer side effects compared to traditional psychotropic medications. Additionally, Metformin's role in addressing metabolic issues might improve overall physical health in patients, which is a significant concern for individuals with psychosis.

What evidence suggests that metformin might be an effective treatment for cannabis use and psychosis?

Studies have shown that metformin, a drug commonly used for diabetes, might help with changes in brain white matter seen in other conditions. White matter is crucial for communication between different parts of the brain. Although limited information exists on using metformin for cannabis-related psychosis, its effect on white matter suggests potential benefits. Additionally, metformin already reduces some side effects of antipsychotic medications, indicating it may aid in treating psychosis. While more research is needed, these findings offer a promising starting point for exploring metformin's potential benefits. Participants in this trial will receive 6 months of daily metformin treatment to further investigate these potential benefits.16789

Who Is on the Research Team?

PG

Philip G Tibbo, MD

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18-25 years old and part of the Nova Scotia Early Psychosis Program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily Metformin treatment and undergo assessments at baseline, 3 months, and 6 months

6 months
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Metformin

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: MetforminExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials
302
Recruited
95,300+

Dalhousie University

Collaborator

Trials
177
Recruited
402,000+

Citations

The Impact of Cannabis Use on Clinical Outcomes in Recent ...

A recent meta-analysis found that giving up substance use was associated with significant improvement in symptoms and disability in early stage psychosis but ...

Influence of cannabis use on incidence of psychosis in people ...

Of those who did not become psychotic, 51.4% had persistent symptoms and 48.6% were in remission. There was no significant association between any measure of ...

Teen cannabis use linked to psychosis and bipolar ...

Teens who reported using cannabis had twice the risk of developing two serious mental illnesses: bipolar, which manifests as alternating ...

Registered Ongoing Studies

Unfortunately, cannabis use can result in deleterious consequences for those in treatment, including developing more severe psychopathology and poorer treatment ...

New study reveals potential biological link between ...

Researchers discover regular cannabis use is linked to signs of increased dopamine levels in the brain, a key factor in psychosis.

Cannabis and Diabetes: What Your Patients Should Know

“In T1D, cannabis use is associated with a higher risk of diabetic ketoacidosis and related hospitalizations, likely due to nausea, vomiting, or ...

Metformin for early comorbid glucose dysregulation and ...

Our results show that metformin improved dysglycemia and insulin sensitivity, independent of weight loss, in a young population with prediabetes ...

The Longitudinal Risk of Psychosis as an Adverse Outcome

The results of these meta-analyses show that persons who develop psychosis experience onset of psychosis about 2-3 years earlier if they are cannabis users.

Metformin: Is it a drug for all reasons and diseases?

Metformin was first used to treat type 2 diabetes in the late 1950s and in 2022 remains the first-choice drug used daily by approximately 150 million people ...