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The Montreal model of ketamine-therapy for alcohol use disorder and comorbid treatment-resistant depression: protocol for a feasibility trial

Por: McAnulty · C. · Lavoie · P. · Cyr · S. · Lavin · P. · Elkrief · L. · Richard-Devantoy · S. · Rizkallah · E. · Lesperance · P. · Gamin · N. · Lembke · A. · Jutras-Aswad · D. · Greenway · K. · Garel · N.
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.

Serological profile of naïve patients affected by the first sars-cov-2 variant: A prospective study

by Wafa Dhouib, Meriem Kacem, Oumayma belghayeb, Meriem Oumaima Beji, Cyrine Bennasrallah, Ameni Maatouk, Imen Zemni, Hela Abroug, Ines bouanene, Haythem Sriha, Maha Mastouri, Mourad ghali, Asma Sriha Belguith, Manel Ben Fredj

Background

Understanding post-infection immunity with the first SARS-CoV-2 variant may provide valuable insights into the duration and effectiveness of the humoral immune response. This study aims to characterize the serological profile of naïve individuals infected with the first SARS-CoV-2 variant.

Methods

A prospective study with repeated measures was conducted in Tunisia, from March to October 2020, during the first wave of COVID-19. Adults confirmed with confirmed COVID-19 were monitored during the first wave of the pandemic. ELISA blood tests were conducted at multiple intervals: day 7, day 14, and at 1, 2, 3, 4, and 6 months post-infection.

Results

173 serum samples were collected from immunologically naïve individuals infected with the first circulating SARS-CoV-2 variant, ranging from 7 days to 6 months post-RT-PCR confirmation. The study revealed a robust humoral immune response in most participants, with 94.1% testing positive for IgM anti-N, 88.2% for IgM anti-S, 98% for IgG anti-N, and 100% for IgG anti-S antibodies. Anti-N IgM antibodies peaked at days 14 and 30 with high positive values (>0.260), while anti-S IgM antibodies showed elevated levels (>0.990) at days 7 and 14. For IgG, anti-N antibodies reached their highest levels (>0.810) at month 4, while anti-S IgG antibodies maintained high positive values (>0.490) at days 7 and 14, and remained elevated at months 4 and 6. No significant differences in antibody levels were observed based on gender, age, comorbidities, or symptoms presence.

Conclusion

A typical adaptive immune response was observed in naïve individuals infected with the initial SARS-CoV-2 variant, showing typical IgM and IgG antibody production from day 7 to month 6. We specifically investigated immunologically naïve individuals infected with the first circulating SARS-CoV-2 variant, from the earliest stage of infection, a context that is no longer reproducible.

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