Ketamine for Reduction of Alcoholic Relapse (KARE)

September 9, 2021 updated by: University College, London

A Phase II, Randomised, Double-blind, Placebo- Controlled, Multi-site, Parallel Group Clinical Trial to Examine Ketamine as a Pharmacological Treatment for Alcohol Dependence in an Alcohol Dependent Population

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Exeter, United Kingdom, EX4 5DW
        • NIHR Exeter Clinical Research Facility
      • London, United Kingdom, NW1 2BU
        • NIHR UCLH Clinical Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse Rates
Time Frame: 6 months
Time line follow back
6 months
Percentage Days Abstinent
Time Frame: 6 months
Time line follow back
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Principal Investigator: Celia Morgan, Ph.D., UCL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

February 1, 2020

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 5, 2016

First Posted (ESTIMATE)

January 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2021

Last Update Submitted That Met QC Criteria

September 9, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/0253.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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