Clinical TrialAlcohol Use Disorder (AUD)KetamineKetamineRecruiting

Ketamine-assisted psychological therapy to reduce alcohol relapse

This double-blind, randomised, controlled trial (n=280) will investigate the efficacy of ketamine-assisted psychological therapy in severe alcohol use disorder (AUD) patients.

Target Enrollment
280 participants
Study Type
Phase III interventional
Design
Randomized, double Blind

Detailed Description

Multi-centre, double-blind randomised parallel-group Phase III trial comparing three weekly IV ketamine infusions (0.8 mg/kg) with low-dose ketamine (0.05 mg/kg) in people with severe AUD, combined with seven sessions of psychological support.

Primary outcome is number of heavy drinking days at six months (TLFB), with corroborating measures including breathalyser, continuous transdermal monitoring and urine biomarkers; secondary outcomes include abstinence, liver biomarkers, functioning, depressive symptoms, craving and health-economic measures.

Participants receive three 40-minute IV infusions (one per week) and seven psychological support sessions (therapy or alcohol education); randomisation and allocation performed via REDCap Academic.

Study Protocol

Preparation

sessions

Dosing

3 sessions
40 min each

Integration

7 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Ketamine 0.8 mg/kg

experimental

Three weekly IV infusions of ketamine 0.8 mg/kg plus psychological support.

Interventions

  • Ketamine0.8 mg/kg
    via IV• weekly• 3 doses total

    Three 40-minute IV infusions (one per week).

Ketamine 0.05 mg/kg

active comparator

Three weekly IV infusions of low-dose ketamine (active comparator) plus psychological support.

Interventions

  • Ketamine0.05 mg/kg
    via IV• weekly• 3 doses total

    Three 40-minute IV infusions (one per week); low-dose active comparator.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Current participant inclusion criteria as of 28/06/2024:
  • 1. 18 years old and over
  • 2. Meet DSM-5 criteria for severe Alcohol Use Disorder
  • 3. Abstinent from alcohol at randomisation (verified with withdrawal symptom checklist and breathalyser BAC level 0.00)
  • 4. Seeking to reduce or quit alcohol long-term
  • 5. Willing and able to consent and comply with trial procedure
  • 6. People of childbearing potential and their sexual partners must be willing to use an effective method of contraception (and must agree to continue for 6 weeks after the last dose of the IMP). Participants must be willing to inform the trial team if pregnancy occurs.
  • 7. People of childbearing potential must have a negative pregnancy test within 28 days prior to being registered for trial treatment and on the day of first treatment.

Exclusion Criteria

  • Current participant exclusion criteria as of 28/06/2024:
  • 1. Currently taking any other alcohol relapse prevention medication
  • 2. Current uncontrolled hypertension (systolic ≥150 mmHg or diastolic ≥100 mmHg)
  • 3. Being actively treated for a current co-morbid substance use disorder (SUD) or having been treated in the past 12 months. If the participant is currently in treatment for a comorbid SUD but is abstinent from any substance use and has a negative urine drug screen (except cannabis and benzodiazepine) participant could be included at the discretion of the investigator.
  • 4. History of ketamine use disorder as assessed by the SCID.
  • 5. Pregnant or breast-feeding
  • 6. Not willing to use effective contraception or (people of child-bearing potential) take pregnancy test.
  • 7. Use of another experimental IMP that is likely to interfere with the trial medication within 3 months of trial enrolment.
  • 8. Known allergies to ketamine or excipients of IMP.
  • 9. Meets current criteria for or has a history of any psychotic illness including substance induced psychosis.
  • 10. Current suicide risk as judged clinically and using CSSR or a history of a suicide attempt within the past year.
  • 11. BMI < 16 or > 35 kg/m²
  • 12. Positive urine drug screen for ketamine.
  • 13. Where there are “Special warnings and precautions for use for ketamine infusion” according to the SmPC.
  • 14. Where risk vs benefit ratio is not in favour of giving ketamine, with assessment made by physical examination by medically qualified trial personnel, self-report, or inspection of the medical notes.
  • 15. Received any previous ketamine treatment.

Study Details

Locations

NIHR Exeter Clinical Research Facility — Exeter, England
Oxford Health NHS Foundation Trust — Oxford, England
Surrey and Borders Partnership NHS Foundation Trust — Chertsey, England
NIHR Brighton & Sussex Clinical Research Facility — Sussex, England
NIHR South London and Maudsley Clinical Research Facility at King's — London, England
Greater Manchester Mental Health NHS Foundation Trust — Manchester, England
University Hospitals Plymouth NHS Trust — Plymouth, England
Imperial College Healthcare NHS Trust — London, England

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