KARE: Ketamine for reduction of Alcoholic Relapse
- Conditions
- Severe Alcohol Use DisorderMedDRA version: 21.0Level: LLTClassification code 10001585Term: Alcohol abuse chronicSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2015-000222-11-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 96
18 - 60 years old
Meet either a) DSM-5 criteria for severe alcohol use disorder and b) DSM-IV criteria for alcohol dependence
Currently abstinent (breathlyser BAC level 0.02 and negative urine drug and alcohol screen)
Minimum of mild depression(>14 on Beck Depression Inventory-II)
Capacity to give informed consent as defined by GCP guidelines
Willing and able to wear a SCRAM-X bracelet for 6 months
Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation and inform the trial if pregnancy occurs
Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment and on day of first treatment.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 96
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
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; co-morbid current psychiatric diagnosis excluding depression as identified by DSM-5 or DSM-IV SCID
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 Summary of Product Characteristics with ketamine:
Barbiturates and/or narcotics
Halogenated anaesthetics
Atracurium and tubocurarine
Central nervous system (CNS) depressants (e.g. phenothiazines, sedating H1 – blockers or skeletal muscle relaxants)
Anxiolytics, sedatives and hypnotics
Thiopental, thyroid hormones
Antihypertensive agents
Theophylline and methylxanthine
OR psychotropic drug use at screening assessment or during treatment weeks
Liver function tests > 3 times normal levels
Where there are Special warnings or precautions for use according to the Summary of Product Characteristics 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:
Acute intermittent porphyria
Dehydration or hypovolemia
Hyperthyroidism, or patients receiving thyroid replacement
Pulmonary or upper respiratory tract infection
Severe Coronary artery disease, Cerebrovascular accident or cerebral trauma
Diabetes
Known glaucoma or globe injuries
Cirrhosis
Epilepsy
Neurological condition/brain damage
Intracranial mass lesions, presence of head injury or hydrocephalus
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 Investigational Medicinal Product and placebo
Use of another investigational medicinal product that is likely to interfere with the study medication within 3 months of study enrolment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method