Clinical TrialTreatment-Resistant Depression (TRD)KetamineRecruiting

ACT for Alcohol Use Disorder and Depression

This interventional single-group feasibility study (n=20) will assess 8 weekly ACT sessions combined with clinic IV ketamine infusions for adults (18–70) with alcohol use disorder and treatment-resistant depression.

Target Enrollment
20 participants
Study Type
Phase NA interventional
Design
Non-randomized

Detailed Description

Single-group feasibility study assessing combined Acceptance and Commitment Therapy (8 weekly individual sessions) and clinic-administered IV ketamine infusions in adults with AUD and treatment-resistant depression; primary outcomes are feasibility and preliminary clinical effects on alcohol consumption and depressive symptoms.

Interventions: subanesthetic IV ketamine infusions delivered per CHUM ketamine clinic protocol alongside eight one-hour ACT sessions delivered by trained psychologists. Safety monitoring includes vitals, laboratory tests and standard ketamine clinic precautions.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

8 sessions
60 min each

Therapeutic Protocol

act

Study Arms & Interventions

ACT + ketamine

experimental

Single-group intervention combining clinic IV ketamine infusions with Acceptance and Commitment Therapy (ACT).

Interventions

  • Ketamine
    via IV• per clinic protocol

    Subanesthetic IV ketamine infusions for TRD/AUD; dose and schedule per clinic protocol.

  • Compound
    • weekly

    Acceptance and Commitment Therapy: 8 one-hour individual sessions delivered by a licensed psychologist.

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Patients who satisfy the following inclusion and exclusion criteria of the study will be invited to enroll:
  • 1. Have a diagnosis of treatment-resistant unipolar or bipolar depression (TRD) (defined as the failure to respond to at least two adequate trials of psychotropics with Level 1 evidence against bipolar or unipolar depression, according to Canadian national depression guidelines)
  • 2. Have comorbid Alcohol Use Disorder (AUD) as diagnosed by a trained psychiatrist,
  • 3. Have been accepted for treatment by IV ketamine for depression and AUD (Full inclusion and exclusion criteria are provided below. This includes solely clinical criteria, which will be verified by the clinical team at the CHUM neuromodulation ketamine clinic.)
  • Additional criteria:
  • Provision of written informed consent after reading the patient information handout;
  • Desire to engage in 8 weekly psychotherapy sessions;
  • No changes to medications during treatment;
  • Alcohol Use Disorder (AUD) as diagnosed by a trained psychiatrist, with an average daily ethanol consumption of at least a moderate risk according to the WHO risk level (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);
  • Bipolar and unipolar depressive episode, current episode of depression (DSM-5) despite at least two adequate trials of psychotropics with Level 1 evidence against bipolar and unipolar depression as per the Montgomery-Asberg Depression Rating Scale (MADRS) ≥ 20;
  • Age > 18-70 years old;
  • No contraindication to ketamine;
  • Accept to abstain from consuming grapefruit juice on the day of the ketamine infusions as it may alter the metabolism of ketamine;
  • Accept to abstain from driving or operating heavy machinery.

Exclusion Criteria

  • Exclusion Criteria:
  • Participants will be excluded if any of the following criteria are met:
  • Currently participating in other evidence-based psychotherapeutic intervention for mood disorders or substance abuse
  • Are not able to commit to the study protocol secondary to professional/personal obligations
  • Are non-English or non-French speaking
  • Other psychiatric comorbidity than MDD/TRD and AUD
  • Prior or current substance abuse or dependence other than AUD (except for caffeine or nicotine dependence) and/or recent history (last 12 months) of cannabis abuse or dependence, as defined by DSM-5 criteria
  • In the context of its legalization, recreational use that does not meet criteria for a substance use disorder and/or is not deemed to be negatively impacting patients' physical and mental health will not justify the exclusion from the study just as it does not justify the exclusion from purely clinical treatment by ketamine
  • The subject's depressive symptoms have previously demonstrated non-response to esketamine or ketamine in the current major depressive episode
  • Known intellectual deficiency or autism spectrum disorder
  • Unable to accommodate regular visits to the ketamine clinic at the CHUM
  • Depression evaluated as secondary to stroke, cancer or other severe medical illnesses
  • Known risk factors for intracranial hemorrhage, including previous significant trauma, known aneurysm, or previous neurosurgery
  • Evidence of clinically relevant disease, e.g., uncontrolled hypertension, renal or hepatic impairment, significant coronary artery disease (myocardial infarct within a year prior to initial randomization), cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome
  • Significant hearing impairment not improved with hearing aids and/or sound amplification or unwillingness to listen to music during treatment
  • A positive toxicology screen for drugs that are not prescribed
  • Unwilling or unable to hold benzodiazepines from the evening prior to the infusion of ketamine
  • Unwilling or unable to hold alcohol for 24 hours prior to the infusion of ketamine
  • Unwilling or unable to discontinue any narcotic beginning a minimum of 5 drug half-lives prior to infusion
  • Unwilling or unable to discontinue memantine or lamotrigine (an NMDA antagonist) during infusions, beginning a minimum of 5 drug half-lives prior to infusions
  • Pregnant, lactating, or of childbearing potential and not willing to use an approved method of contraception during the ketamine infusion
  • Female subjects of childbearing potential must have a negative urine pregnancy test at the beginning
  • A clinical finding that is unstable or that, in the opinion of the treating clinician(s), would be negatively affected by, or would affect, the medication (e.g., diabetes mellitus, unstable angina)
  • Liver function tests AST and ALT three times the upper normal limit at screening
  • ECG results considered significantly abnormal as determined by the clinician(s)
  • History of seizure disorder, except febrile convulsions
  • Known history of intolerance or hypersensitivity to ketamine
  • Acute psychotic symptoms, as judged by the initial clinical interview or reported by referring clinicians
  • Any significant, recent, acute decline in exercise tolerance
  • Uncorrected hypothyroidism or hyperthyroidism
  • Subjects needing a thyroid hormone supplement to treat hypothyroidism must have been on a stable dose of the medication for 3 months prior to beginning infusions
  • Clinically significant deviation from the reference range in clinical laboratory test results as judged by the clinician(s).

Study Details

Locations

Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada

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