Alcohol dependence syndrome
Conditions
Interventions
Experimental group:Three injections of esketamine intravenously (0.6mg/kg, continuous 40min)
Control group:Three intravenous injections of midazolam (0.025mg/kg, continuous 40min)
Sponsors
Chaohu Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. between 18 and 65 years old regardless of gender 2.meet the diagnostic criteria of DSM-5 (5th edition of Diagnostic and Statistical Manual of Mental Disorders) for moderate and severe alcohol use disorders 3.score on the alcohol use disorder recognition test (AUDIT) is between 8 and 40 meeting the criteria for dangerous drinking (8-14) or moderate to severe AUD (15-40) 4.those who are currently in a state of abstinence from alcohol and who have abstained from alcohol for at least 24 hours and whose results of other active substances are negative by urine test. 5. at screening and baseline the pregnancy test (urine) results of women of childbearing age were negative. Male and female subjects of childbearing age agreed to use effective contraception throughout the study and within at least 28 days after the last use of the trial drug. 6.Primary school education or above able to understand the content of the study volunteer to participate in this study and sign the informed consent form
Exclusion criteria
Exclusion criteria: 1.those who are currently in a state of severe withdrawal unconsciousness or coma and whose vital signs are unstable 2. currently suffering from DSM-5 (5th edition of Diagnostic and Statistical Manual of Mental Disorders) other mental disorders other than alcohol dependence and depression including organic psychiatric disorders schizophrenia bipolar disorder etc. 3. History of drug dependence history of harmful use of psychoactive substances or previous recreational use of ketamine 4. hypertensive patients with poorly controlled blood pressure (SBP>=140mmHg or DBP >=90 mmHg during screening and baseline visits) 5. according to the researchers there is a clear risk of suicide or violence 6. The patient is currently accompanied by psychiatric symptoms such as clear hallucinations and delusions, and any one of the positive symptom items (including hallucinations, exaggeration, suspicion, and unusual thinking content) of the Brief Psychiatric Rating Scale (BPRS)) is >1 point; 7. Positive urine toxicology screen at screening or at baseline; 8. Those who have had previous organic brain lesions or severe trauma to the brain; 9.Patients with severe heart, liver and kidney insufficiency, metabolic diseases and other serious physical diseases; 10. Clinically significant electrocardiogram (ECG) abnormalities at screening, including sinus bradycardia (resting heart rate < 50 beats/min), atrial fibrillation, 2nd or 3rd degree atrioventricular block, QTc prolongation (QTcF=450 ms for males and 470 ms = females), history of congenital long QT syndrome, or risk of torsade de pointes due to family history of sudden death. 11.Women who are pregnant or breastfeeding; 12.Previous experience of allergy to narcotic drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alcohol craving degree; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive function;Emotional state; | — |
Countries
China
Contacts
Public ContactZhang Kai
Chaohu Hospital of Anhui Medical University
Outcome results
None listed