Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06620276

Acceptance and Commitment Therapy with Ketamine for Alcohol Use Disorder and Treatment-Resistant Depression: A Feasibility Study

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

On this page

AI-Summary

What this Trial Is About

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 mg/kg and may be adjusted up to 1.0 mg/kg 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

Brief Title

ACT_for Alcohol Use Disorder and Depression

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent after reading and understanding the patient information handout
  • Diagnosed with Alcohol Use Disorder (AUD) by a trained psychiatrist
  • Diagnosed with treatment resistant unipolar or bipolar depression, defined as failure to respond to two or more adequate treatment trials
  • Willing to participate in eight weekly psychotherapy sessions
  • No changes to psychotropic medications during study treatment
  • Average daily alcohol consumption at moderate risk level or higher as defined by WHO standards
  • Current bipolar or unipolar depressive episode with MADRS score of 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 psychotherapy for mood or substance abuse disorders
  • Unable to commit to study protocol due to personal or professional obligations
  • Non-English or non-French speaking
  • Psychiatric comorbidity that is likely to take precedence over AUD or TRD
  • Acute psychotic disorder or symptoms
  • Current or past substance abuse or dependence other than AUD (except caffeine or nicotine)
  • Non-response to ketamine or esketamine during current depressive episode
  • Known intellectual disability or autism spectrum disorder
  • Unable to attend regular visits to the CHUM Neuromodulation clinic
  • Depression caused by stroke, cancer, or severe medical conditions
  • Risk factors for intracranial hemorrhage such as trauma or aneurysm
  • Uncontrolled hypertension or significant heart or cerebrovascular disease
  • Kidney or liver impairment
  • Pregnant, breastfeeding, or of childbearing potential without approved contraception and negative pregnancy test
  • Abnormal liver function tests (AST or ALT three times above normal)
  • Significant abnormal ECG results
  • Unstable or untreated thyroid disorders
  • Any unstable or significant medical condition judged to interfere with treatment
  • Positive drug screen for non-prescribed substances
  • Unwilling to abstain from benzodiazepines, narcotics, or NMDA antagonists 12 hours before infusions
  • Known allergy or intolerance to ketamine
  • Significant hearing loss not corrected by aids
  • Recent significant decline in exercise tolerance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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

S

Samuel Cyr, PhD

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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Published Research Related To This Trial

The Prevalence and National Burden of Treatment-Resistant Depression and Major Depressive Disorder in the United States.

Maryia Zhdanava, Dominic Pilon, Isabelle Ghelerter...

https://pubmed.ncbi.nlm.nih.gov/33989464

Barriers to the Implementation of Electroconvulsive Therapy (ECT): Results From a Nationwide Survey of ECT Practitioners.

Samuel T Wilkinson, Brandon M Kitay, Annie Harper...

https://pubmed.ncbi.nlm.nih.gov/33971727

Comparison Between the Montgomery-Asberg Depression Rating Scale-Self and the Beck Depression Inventory II in Primary Care.

Carl Wikberg, Shabnam Nejati, Maria E H Larsson...

https://pubmed.ncbi.nlm.nih.gov/26644958

Psychedelics and the new behaviourism: considering the integration of third-wave behaviour therapies with psychedelic-assisted therapy.

Zach Walsh, Michelle S Thiessen

https://pubmed.ncbi.nlm.nih.gov/30251904

Clinical factors associated with treatment resistance in major depressive disorder: results from a European multicenter study.

Daniel Souery, Pierre Oswald, Isabelle Massat...

https://pubmed.ncbi.nlm.nih.gov/17685743