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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

Tracking Information
First Submitted Date  ICMJE January 5, 2016
First Posted Date  ICMJE January 7, 2016
Last Update Posted Date September 26, 2019
Actual Study Start Date  ICMJE October 2016
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2016)
Relapse rates [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02649231 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine for Reduction of Alcoholic Relapse
Official Title  ICMJE Reducing Relapse in Severe Alcohol Use Disorder With the NMDA Receptor Antagonist Ketamine
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary Alcohol Use Disorder
Intervention  ICMJE
  • Drug: Ketamine
    0.8 mg/kg ketamine
  • Drug: Placebo
    0.9% saline
  • Behavioral: Psychological Therapy
    Manualised relapse prevention based CBT
  • Behavioral: Alcohol Education
    Simple education about alcohol effects
Study Arms  ICMJE
  • Experimental: Ketamine+Psychological Therapy
    Ketamine with psychological therapy
    Interventions:
    • Drug: Ketamine
    • Behavioral: Psychological Therapy
  • Active Comparator: Ketamine+Education
    ketamine with alcohol education
    Interventions:
    • Drug: Ketamine
    • Behavioral: Alcohol Education
  • Active Comparator: Placebo+Psychological Therapy
    placebo with psychological therapy
    Interventions:
    • Drug: Placebo
    • Behavioral: Psychological Therapy
  • Placebo Comparator: Placebo+Education
    placebo with simple alcohol education
    Interventions:
    • Drug: Placebo
    • Behavioral: Alcohol Education
Publications * McAndrew A, Lawn W, Stevens T, Porffy L, Brandner B, Morgan CJ. A proof-of-concept investigation into ketamine as a pharmacological treatment for alcohol dependence: study protocol for a randomised controlled trial. Trials. 2017 Apr 4;18(1):159. doi: 10.1186/s13063-017-1895-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 5, 2016)
96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02649231
Other Study ID Numbers  ICMJE 13/0253.
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Celia Morgan, Ph.D. UCL
PRS Account University College, London
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP