MORE-KARE: Investigation of increasing alcohol abstinence with ketamine-assisted psychological therapy in severe alcohol use disorder.
Overview
Do you want to stop drinking or reduce your alcohol intake?
If you have an alcohol problem and want help staying sober, we may be able to help.
We are testing out a new treatment and are looking for volunteers.
If you have an alcohol use disorder and are ready to stop drinking or have already done so, you may be eligible to take part in the MORE-KARE trial.
The study involves having three infusions of the study drug, alongside psychological support.
Are you interested in taking part in this study?
Find out more by filling in this form
Planned end date
31 Jul 2026 00:00Conditions
Addictions - alcoholInclusion Criteria
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 7 days prior to being registered for trial treatment and on the day of first treatment.
* Highly effective contraception is defined as one of the following: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable); intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomised partner; practising true abstinence (when this is in line with the preferred and usual lifestyle of the subject). People of child-bearing potential could also be post-menopausal (no menses for 12 months without an alternative
medical cause) or be surgically sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
Exclusion Criteria
1. Currently taking any other alcohol relapse prevention medication
2. Current uncontrolled hypertension (systolic > 140mm Hg or diastolic > 90mm Hg)
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
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.