Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06620276

ACT_for Alcohol Use Disorder and Depression

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2026-03-05

30

Participants Needed

1

Research Sites

161 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Alcohol use disorders (AUDs) and depressive disorders frequently coexist, complicating the clinical management of patients suffering from them. Taken separately, these two disorders have a significant prevalence in the population, and a recent meta-analysis concluded that coexistence could reach 1 in 5 patients (20.8%). This comorbidity represents a considerable challenge, particularly in cases of treatment-resistant depression (TRD), where patients do not respond to conventional pharmacological interventions. Since alcohol can act as a powerful trigger for depressive symptoms, and conversely, a depressive state increases the risk of alcohol abuse, the question of intervention sequence is also of clinical interest: should priority be given to treating TRD, AUD or both simultaneously? This question raises a major issue for healthcare professionals, as current conventional therapeutic approaches present limitations in the concomitant management of these complex disorders. Thus, in certain clinical settings, ketamine has emerged as a promising intervention to treat both TRD and AUD. In fact, ketamine has been shown to produce rapid but only transient antidepressant effects, and is part of the possible treatment arsenal for TRD. The potential of ketamine in the treatment of AUD has also been explored in recent studies, with a few small randomized controlled trials. In these trials, the combination of ketamine with psychotherapy, versus placebo, was investigated as a means of alleviating AUD. Ketamine was shown to increase abstinence rates, time to relapse and decrease the number of heavy drinking days. Acceptance and Commitment Therapy (ACT) is a form of cognitive-behavioural therapy that emphasizes psychological flexibility and acceptance of difficult emotions and thoughts without judgment, a type of psychotherapy particularly relevant to AUD. Thus, adding ACT to ketamine treatment could increase the duration of ketamine's effect on depressive symptoms, while reducing AUD. In view of this accumulated evidence of the potential benefit of ketamine and ACT, adding acceptance and commitment therapy to ketamine appears to be a promising option for improving outcomes in patients diagnosed with TRD comorbid with AUD. This study will not only verify the feasibility of this type of intervention in this particular patient population, but also the preliminary effects on their alcohol consumption and depressive symptoms.

CONDITIONS

Official Title

ACT_for Alcohol Use Disorder and Depression

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provision of written informed consent after reading and understanding the patient information handout
  • Diagnosed with Alcohol Use Disorder by a trained psychiatrist
  • Diagnosed with treatment resistant unipolar or bipolar depression, defined as failure to respond to 2 or more adequate trials per Canadian national guidelines
  • Willing to participate in 8 weekly psychotherapy sessions
  • No changes to psychotropic medications during treatment
  • Average daily alcohol consumption at least moderate risk per WHO levels (Men: >40 to 60 g/day or >2.9 to 4.3 drinks; Women: >20 to 40 g/day or >1.4 to 2.9 drinks)
  • Current bipolar or unipolar depressive episode with MADRS score 20 or higher
  • Age between 18 and 70 years
  • Agree to avoid grapefruit juice on ketamine infusion days
  • Agree to abstain from driving or operating heavy machinery after infusions until the next day
Not Eligible

You will not qualify if you...

  • Currently participating in other evidence-based psychotherapies for mood or substance use disorders
  • Unable to commit to study protocol due to personal or professional obligations
  • Not fluent in English or French
  • Psychiatric comorbidity likely to overshadow AUD or TRD
  • Acute psychotic disorder or symptoms
  • Current or past substance abuse or dependence other than AUD (except caffeine or nicotine)
  • Nonresponse to ketamine or esketamine during current depressive episode
  • Known intellectual disability or autism spectrum disorder
  • Unable to attend regular clinic visits
  • Depression caused by stroke, cancer, or severe medical conditions
  • Risk factors for intracranial hemorrhage (trauma, aneurysm, neurosurgery)
  • Uncontrolled hypertension or serious cardiovascular or cerebrovascular disease
  • Kidney or liver impairment
  • Pregnant, breastfeeding, or potential to conceive without approved contraception and negative pregnancy test at baseline
  • Abnormal liver tests (AST or ALT 3 times above normal)
  • Significant abnormal ECG results
  • Unstable or untreated thyroid conditions
  • Any unstable or significant medical condition interfering with treatment
  • Positive drug screen for non-prescribed substances
  • Unwilling to abstain from benzodiazepines, narcotics, or NMDA antagonists 12 hours before infusions
  • Known ketamine intolerance or hypersensitivity
  • Significant hearing loss not improved by hearing aids
  • Recent significant decline in exercise tolerance

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada, H2X3E4

Actively Recruiting

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Research Team

N

Nicolas Garel, MD MSc

CONTACT

S

Samuel Cyr, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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