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96 recently detoxified alcoholics will be randomized to receive either 3 sessions ketamine (0.8 mg/kg IV over 45 minutes) or placebo plus manualised psychological therapy, or 3 sessions of ketamine or placebo plus simple psychoeducation. Patients will be assessed at 3 and 6 months on a range of psychological and biological variables. Primary endpoints will be % days abstinent at 6 months and relapse rates at 6 months. Secondary endpoints include depressive symptoms, craving, quality of life.
Enrollment
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Inclusion criteria
Exclusion criteria
Currently taking any other relapse prevention medication or anti-depressants;
Uncontrolled hypertension, systolic 140mm Hg or greater and diastolic 90mm Hg or greater;
<16 or > 35 BMI
History of psychosis, or in a first-degree relative as identified by DSM-5 or DSM-IV SCID; co-morbid current psychiatric diagnosis excluding depression, identified via self-reported or identified by a medical professional;
Previous or current diagnosis of substance dependence / severe substance misuse disorder;
History of neuropsychological difficulties
One or more previous confirmed seizures;
Currently taking daily prescribed medication contraindicated in the SPC with ketamine:
Liver function tests > 3 times normal levels
Where there are "special warnings or precautions for use" according to the SPC and 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:
Suicidal ideation.
Not willing to use effective contraception or (females) take pregnancy test;
Allergic reaction to ketamine;
>10 previous detoxifications from alcohol;
Pregnant or breastfeeding;
Allergies to excipients of IMP or placebo;
Use of another experimental investigational medicinal product that is likely to interfere with the study medication within 3 months of study enrolment.
Primary purpose
Allocation
Interventional model
Masking
96 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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