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insulin gip agonist rct n=100 2026-11-15 ClinicalTrials

Tirzepatide Explored as Potential Treatment for Cannabis Use Disorder

Trial of Tirzepatide for the Treatment of Cannabis Use Disorder

Background

Cannabis Use Disorder (CUD) is a prevalent condition characterized by impaired control over cannabis use, significant distress, and functional impairment, affecting millions globally. Current pharmacological treatments for CUD are limited, highlighting a critical unmet medical need. This Phase 2 pilot trial aims to evaluate the safety and efficacy of tirzepatide as a novel therapeutic option for moderate to severe CUD.

Study Design

Population
100 patients with moderate or severe Cannabis Use Disorder (CUD).
Intervention
Tirzepatide, a dual GLP-1 and GIP receptor agonist, dose and route not specified.
Comparator
Placebo.
Outcome
The primary efficacy outcome will be the reduction in cannabis use, with safety and tolerability also being evaluated.

Results

As a pilot trial, this study is designed to gather initial data on the potential of tirzepatide for CUD. It aims to evaluate the safety and tolerability of tirzepatide in this patient population, monitoring for adverse events and dropout rates. The primary efficacy outcome will be the reduction in cannabis use, with secondary outcomes including changes in craving, withdrawal symptoms, and overall CUD severity. The trial will determine if tirzepatide can significantly reduce cannabis use frequency and severity compared to placebo. The study's main objective is to establish whether tirzepatide demonstrates a favorable safety profile and preliminary efficacy signals in 100 patients with moderate or severe CUD, paving the way for larger confirmatory trials.

Why It Matters

Given the significant public health burden of Cannabis Use Disorder and the scarcity of effective pharmacological interventions, a successful outcome from this trial could be transformative. Tirzepatide, a dual GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide) receptor agonist, has shown promise in other areas like obesity and diabetes, and its potential role in addiction is a novel and exciting avenue. If positive, these findings could lead to the development of the first FDA-approved medication specifically for CUD, offering a much-needed treatment option. Future steps would involve larger Phase 3 clinical trials to confirm efficacy and safety in a broader population.


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Source: clinicaltrials:NCT07468552 · Ingested 2026-04-29 · Digest: gemini-2.5-flash