The Montreal model will test whether plus intravenous ketamine is feasible for people with alcohol use disorder and .
Evidence
This is a protocol for a single-group, open-label feasibility trial of 30 participants receiving eight ACT sessions and six ketamine infusions at a Montreal ketamine clinic.
Caveat
Because the trial is uncontrolled and designed around feasibility, it will not by itself establish efficacy for depression, alcohol use, or quality-of-life outcomes.
Simplified
BACKGROUND: Alcohol use disorder and (TRD) often co-occur, presenting a major clinical challenge with limited effective treatments. However, ketamine produces rapid antidepressant effects and has shown promise in reducing alcohol use, and (ACT) can be effective for both substance use and mood disorders. This study explores the feasibility and acceptability of combining ACT with ketamine within the framework of the Montreal Model-a structured, integrative psychedelic ketamine therapy developed for severe TRD.
METHODS AND ANALYSIS: This study is a single-group, open-label feasibility trial at the Centre hospitalier de l'Université de Montréal (CHUM) Neuromodulation Ketamine Clinic in Montreal, Canada. 30 participants diagnosed with both alcohol use disorder and treatment-resistant depression will receive eight weekly in-person or virtual ACT sessions in addition to six intravenous ketamine infusions. The primary outcome is feasibility, assessed through study completion and protocol adherence. Secondary outcomes include recruitment rate, tolerability, safety, data completeness and healthcare resource use. Exploratory measures will examine changes in depressive symptoms, alcohol use and quality of life using validated tools. A subset of participants will participate in semistructured qualitative interviews to explore their experiences.
ETHICS AND DISSEMINATION: This study was approved by the ethics committee of the CHUM on 14 May 2025. The results of the trial, including primary and secondary outcomes, will be published in peer-reviewed scientific journals.
TRIAL REGISTRATION NUMBER: NCT06620276.
Key numbers
30
Participants Enrolled
Total number of participants in the trial.
80%
Completion Rate Hypothesis
Expected percentage of participants to complete the study.
75%
Sessions Attended
Expected percentage of scheduled sessions participants will attend.
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Competing interests: KTG has received salary support from the Fonds de Recherche du Québec – Santé (FRQS), and research support from the FRQS, the Canada First Research Excellence Fund, McGill University, the Canadian Institutes of Health Research and the Jewish General Hospital foundation. DJA has received study material from Cardiol Therapeutics for a publicly funded clinical trial not related to this work. He is supported by a senior clinical scientist career award from the Fonds de Recherche du Québec – Santé (FRQS). All other authors have no competing interests to declare.
