Tirzepatide for Cannabis Use Disorder

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
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 tests a new method to help people reduce cannabis use with a medication called Tirzepatide, which has shown potential in curbing cravings. Researchers combine this medicine with Motivational Enhancement Therapy to determine its effectiveness in treating Cannabis Use Disorder (CUD), a condition where cannabis use disrupts daily life. The trial is open to adults who regularly use cannabis and seek help to cut down. Participants should have a Body Mass Index (BMI) of 22 or higher and meet specific criteria for CUD severity. As a Phase 3 trial, this treatment represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking therapy.

Is there any evidence suggesting that Tirzepatide is likely to be safe for humans?

Research has shown that tirzepatide is generally safe for people. Although the FDA has not yet approved it for treating substance use disorders, it is approved for managing type 2 diabetes, indicating a well-understood safety profile for that condition. Studies have found that tirzepatide can help reduce alcohol consumption, suggesting it might also help with cravings. While specific studies on its use for cannabis use disorder are lacking, early results from related trials indicate it is safe when used in recommended doses.12345

Why are researchers excited about this possible treatment for Cannabis Use Disorder?

Tirzepatide is unique because it targets both the GLP-1 and GIP receptors, which are involved in regulating appetite and energy balance. Unlike standard treatments for cannabis use disorder, which often focus on behavioral therapy and support, Tirzepatide offers a novel approach by potentially reducing cravings through a dual mechanism of action. Researchers are excited about this treatment because it could offer a new, pharmacological option for managing cannabis use disorder, providing hope for those who haven't found success with existing therapies.

What evidence suggests that Tirzepatide might be an effective treatment for Cannabis Use Disorder?

Studies have shown that Tirzepatide can help reduce alcohol consumption, suggesting it might also assist with other addictions like Cannabis Use Disorder (CUD). Tirzepatide affects specific parts of the body that control cravings and substance use, similar to its role in managing overeating and alcohol use. Although researchers are still gathering direct evidence of Tirzepatide's effectiveness for CUD, its ability to reduce alcohol cravings is promising. This trial will provide all participants with Tirzepatide alongside psychotherapy over a 12-week treatment period, potentially helping people with CUD by lowering their cannabis use.13467

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with Cannabis Use Disorder who are interested in reducing or stopping their cannabis use. Participants should be able to attend weekly sessions and receive injections. Specific inclusion and exclusion criteria will apply.

Inclusion Criteria

A Body Mass Index (BMI) ≥ 22
DSM-5 Cannabis Use Disorder diagnosis of at least moderate severity (4+ DSM-5 symptoms)
4 or more days of cannabis use per week
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Exclusion Criteria

I have attended addiction therapy sessions in the past 6 months.
Present a serious suicide risk or likely to require psychiatric hospitalization during the study, as determined by study physician and Columbia Suicide Severity Rating Scale
Any other mental health condition deemed incompatible by the study team
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly injections of Tirzepatide combined with Motivational Enhancement Therapy

12 weeks
12 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

  • Tirzepatide

Trial Overview

The study tests whether weekly injections of Tirzepatide, combined with Motivational Enhancement Therapy (a type of counseling), can help adults with Cannabis Use Disorder reduce or quit cannabis use. This is an early-stage, proof-of-concept trial.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+

Citations

Tirzepatide in the Treatment of Cannabis Use Disorder: A ...

Tirzepatide has been reported to reduce alcohol consumption (Quddos et al., 2023), and therefore may have promising effects as a treatment for ...

Glucagon-like peptide 1 receptor agonists in substance use ...

Primary outcomes focused on reduction of substance use, however, studies varied in how they measured this reduction with some studies focusing on clinical ...

GLP-1s Like Ozempic May Be a New Treatment for Addiction

NIDA is sponsoring a randomized, placebo-controlled clinical trial evaluating Tirzepatide as treatment for cannabis use disorder. This will ...

Tirzepatide and semaglutide for treating obesity-related ...

A recent observational study based on almost 700,000 individuals found that people after being started on semaglutide were ∼ 40 % less likely to be diagnosed ...

Trial of Tirzepatide for the Treatment of Cannabis Use Disorder

The primary Hypothesis is that tirzepatide will be well tolerated within the FDA-recommended dose range and compared with placebo, it will ...

Tirzepatide for the Treatment of Cannabis Use Disorder

This is a pilot randomized cross-over trial to examine the effects of tirzepatide on cue-reactivity among individuals with cannabis use disorder. Detailed ...

Does Tirzepatide Help With Addiction? Current Evidence ...

No, tirzepatide is not FDA-approved for treating substance use disorders or addiction. It is currently approved only for type 2 diabetes mellitus (Mounjaro) and ...