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M Sandelowski
https://pubmed.ncbi.nlm.nih.gov/10940958/Actively Recruiting
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2026-03-05
30
Participants Needed
1
Research Sites
78 weeks
Total Duration
Researchers are evaluating a combined treatment approach for adults with Alcohol Use Disorder AUD and Treatment-Resistant Depression TRD, conditions that often occur together and complicate treatment. This study explores the use of ketamine, known for its rapid but temporary antidepressant effects, alongside Acceptance and Commitment Therapy ACT, a form of psychotherapy aimed at improving psychological flexibility and addressing difficult emotions. The study aims to assess the feasibility and preliminary effects of this combined intervention on alcohol use and depressive symptoms in this challenging patient population. Participants will receive six intravenous ketamine infusions over four weeks, administered twice weekly in the third and fourth weeks, then once weekly in the fifth and sixth weeks. Ketamine doses start at 0.5 mgkg and may be adjusted up to 1.0 mgkg based on response and tolerability. Alongside ketamine, participants will attend eight weekly ACT psychotherapy sessions, each lasting 50 minutes, delivered in person or virtually. The ACT sessions focus on acceptance, values, committed action, and mindfulness exercises to support psychological flexibility and emotional coping. During the study, participants will be monitored closely with breathalyzer tests before each ketamine infusion to ensure abstinence from alcohol. Safety will be tracked through adverse event monitoring, and adherence to both ketamine infusions and psychotherapy sessions will be assessed over 12 weeks. Researchers will evaluate recruitment and consent rates, data collection quality, and resource use during treatment. The study includes careful observation of depressive symptoms and alcohol consumption to understand how the combined treatment affects these conditions.
CONDITIONS
ACT_for Alcohol Use Disorder and Depression
N
Nicolas Garel, MD MSc
S
Samuel Cyr, PhD
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Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive Acceptance and Commitment Therapy (ACT) consisting of eight weekly 50-minute sessions, delivered in person or virtually, combined with six intravenous ketamine infusions over 4 weeks. Ketamine infusions occur twice weekly in weeks 3 and 4, then once weekly in weeks 5 and 6, with monitoring and mindfulness exercises before and during sessions.
8 weekly ACT sessions and 6 ketamine infusions over 4 weeks
Duration - Up to 12 weeks from enrollment
Participants are monitored after completing treatment to assess adherence, safety, and therapeutic outcomes over 12 weeks from enrollment.
Visits scheduled as needed for safety and outcome assessments
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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M Sandelowski
https://pubmed.ncbi.nlm.nih.gov/10940958/M J Bohn, T F Babor, H R Kranzler
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https://pubmed.ncbi.nlm.nih.gov/27929611/Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor