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Ketamine for Reduction of Alcoholic Relapse (KARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02649231
Recruitment Status : Active, not recruiting
First Posted : January 7, 2016
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief Summary:
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 3 and 6 months and relapse rates at 6 months. Secondary endpoints include depressive symptoms, craving, quality of life.

Condition or disease Intervention/treatment Phase
Primary Alcohol Use Disorder Drug: Ketamine Drug: Placebo Behavioral: Psychological Therapy Behavioral: Alcohol Education Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Relapse in Severe Alcohol Use Disorder With the NMDA Receptor Antagonist Ketamine
Actual Study Start Date : October 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine+Psychological Therapy
Ketamine with psychological therapy
Drug: Ketamine
0.8 mg/kg ketamine

Behavioral: Psychological Therapy
Manualised relapse prevention based CBT

Active Comparator: Ketamine+Education
ketamine with alcohol education
Drug: Ketamine
0.8 mg/kg ketamine

Behavioral: Alcohol Education
Simple education about alcohol effects

Active Comparator: Placebo+Psychological Therapy
placebo with psychological therapy
Drug: Placebo
0.9% saline

Behavioral: Psychological Therapy
Manualised relapse prevention based CBT

Placebo Comparator: Placebo+Education
placebo with simple alcohol education
Drug: Placebo
0.9% saline

Behavioral: Alcohol Education
Simple education about alcohol effects




Primary Outcome Measures :
  1. Relapse rates [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet either a) DSM-5 criteria for severe alcohol use disorder and b) DSM-IV criteria for alcohol dependence within the last 12 months;
  • Currently abstinent from alcohol (breathalyser BAC level 0.00) and negative urine drug screening (participants testing positive for THC who do not have a history or current cannabis dependency may be included);
  • 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 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; True abstinence) from the time consent is signed until 6 weeks after treatment discontinuation and inform the trial if pregnancy occurs. For the purpose of clarity, True abstinence is when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence, withdrawal, spermicides only or lactational amenorrhoea method for the duration of a trial, are not acceptable methods of contraception;
  • 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.

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:

    1. Barbiturates and/or narcotics
    2. Atracurium and tubocurarine
    3. Central nervous system (CNS) depressants (e.g. phenothiazines, sedating H1 - blockers or skeletal muscle relaxants)
    4. Anxiolytics, sedatives and hypnotics
    5. Thiopental, thyroid hormones
    6. Antihypertensive agents
    7. Theophylline and methylxanthines.
    8. Halogenated anaesthetics
    9. OR psychotropic drug use at screening assessments or during treatment weeks
  • 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:

    1. Acute intermittent porphyria
    2. Dehydration or hypovolemia
    3. Hyperthyroidism, or patients receiving thyroid replacement
    4. Pulmonary or upper respiratory tract infection
    5. Severe Coronary artery disease, Cerebrovascular accident or cerebral trauma
    6. Diabetes
    7. Known glaucoma or globe injuries
    8. Cirrhosis
    9. Epilepsy
    10. Neurological condition/brain damage
    11. 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649231


Locations
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United Kingdom
NIHR Exeter Clinical Research Facility
Exeter, United Kingdom, EX4 5DW
NIHR/Wellcome UCLH Research Facility
London, United Kingdom, NW1 2BU
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Celia Morgan, Ph.D. UCL

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02649231    
Other Study ID Numbers: 13/0253.
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Ketamine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action