Ketamine for Reduction of Alcoholic Relapse

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2020-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ketamine for the Treatment for Alcohol Use Disorder in the ED

NCT05661669

Alcohol Use Disorder

WITHDRAWN PHASE2

Ketamine for Depression and Alcohol Dependence

NCT01551329

Depression Alcohol Dependence

COMPLETED PHASE1

Ketamine vs. Placebo as Adjunctive Therapies for Severe Alcohol Withdrawal

NCT02823977

Alcohol Withdrawal

WITHDRAWN PHASE4

Ketamine for Combined Depression and Alcohol Use Disorder

NCT06090422

Depression Alcohol Use Disorder

NOT_YET_RECRUITING PHASE1/PHASE2

Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder

NCT02461927

Major Depressive Disorder Alcohol Use Disorder

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Alcohol Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ketamine+Psychological Therapy

Ketamine with psychological therapy

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

0.8 mg/kg ketamine

Psychological Therapy

Intervention Type BEHAVIORAL

Manualised relapse prevention based CBT

Ketamine+Education

ketamine with alcohol education

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

0.8 mg/kg ketamine

Alcohol Education

Intervention Type BEHAVIORAL

Simple education about alcohol effects

Placebo+Psychological Therapy

placebo with psychological therapy

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

0.9% saline

Psychological Therapy

Intervention Type BEHAVIORAL

Manualised relapse prevention based CBT

Placebo+Education

placebo with simple alcohol education

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.9% saline

Alcohol Education

Intervention Type BEHAVIORAL

Simple education about alcohol effects

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketamine

0.8 mg/kg ketamine

Intervention Type DRUG

Placebo

0.9% saline

Intervention Type DRUG

Psychological Therapy

Manualised relapse prevention based CBT

Intervention Type BEHAVIORAL

Alcohol Education

Simple education about alcohol effects

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No