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Recruiting NCT06620276

ACT_for Alcohol Use Disorder and Depression

Trial Parameters

Condition Depression - Major Depressive Disorder
Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Study Type INTERVENTIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2025-05-01
Completion 2026-12-01
Interventions
Acceptance and Commitment TherapyKetamine

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Provision of written informed consent after reading and understanding the patient information handout * Alcohol Use Disorder (AUD) diagnosed by a trained psychiatrist * Diagnosis of treatment resistant unipolar or bipolar depression, defined as failure to respond to ≥2 adequate trials per Canadian national depression guidelines * Willingness to engage in 8 weekly psychotherapy sessions * No changes to psychotropic medications during treatment * Average daily ethanol consumption of at least moderate risk as per WHO risk levels (Men: \>40 to 60 g per day or \>2.9 to 4.3 drinks / Women: \>20 to 40 g per day or \>1.4 to 2.9 drinks) * Bipolar or unipolar depressive episode (DSM5), current episode, with MADRS ≥ 20 * Age 18 to 70 years * Agreement to abstain from consuming grapefruit juice on ketamine infusion days * Agreement to abstain from driving or operating heavy machinery after infusions until the next day Exclusion Criteria: * Current participation in other evide

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