The Montreal model of ketamine-therapy for alcohol use disorder and comorbid treatment-resistant depression: protocol for a feasibility trial
Christina Mcanulty, Philippe Lavoie, Samuel Cyr, Paola Lavín, Laurent Elkrief, Stephane Richard-Devantoy, Élie Rizkallah, Paul Lespérance, Nicolas Gamin, Anna Lembke, Didier Jutras-Aswad, Kyle T. Greenway, Nicolas Garel
BMJ Open March 1, 2026 DOI: 10.1136/bmjopen-2026-116969 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Single-group, open-label feasibility trial Qualitative Peer reviewed |
|---|---|
| Sample size | 30 |
| Population | Adults diagnosed with both alcohol use disorder and treatment-resistant depression |
| Interventions | Ketamine Acceptance and commitment therapy (ACT) |
| Duration | Eight weekly ACT sessions and six intravenous ketamine infusions |
| Topics | Addiction Depression Ketamine Esketamine |
| Keywords | Protocol science Mood Depression economics Patient health questionnaire Randomized controlled trial Clinical trial Research ethics Alcohol dependence Medline Public health Institutional review board Alternative medicine Duloxetine Family medicine Health care Informed consent Clinical psychology |
| Registration | NCT06620276 |
| Key findings | The study aims to assess the feasibility and acceptability of combining ketamine with acceptance and commitment therapy for co-occurring alcohol use disorder and treatment-resistant depression. |
Abstract
Background: Alcohol use disorder and treatment-resistant depression (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 acceptance and commitment therapy (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.
Comparable studies
Other non-randomized and open-label trials on ketamine for addiction, most cited first.