NIPH Clinical Trials Search

Efficacy of Tirzepatide and Nalmefene to Alcohol-Dependence

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	alcohol dependence
Date of first enrollment	23/03/2026
Target sample size	80
Countries of recruitment
Study type	Interventional
Intervention(s)	The Tirzepatide group receives a maintenance dose of 5 mg once weekly as Manjarro via subcutaneous injection. However, treatment begins with 2.5 mg once weekly. After 4 weeks of administration, the dose is increased to 5 mg once weekly based on symptoms. The dose may be adjusted as appropriate based on the patient's condition. If 5 mg once weekly proves insufficient, the dose may be increased by 2.5 mg increments at intervals of 4 weeks or longer. The maximum dose is 15 mg once weekly. However, as this study is 12 weeks in duration, the maximum dose will be limited to 7.5 mg once weekly. The Nalmefene group receives oral administration of 10 mg of nalmefene hydrochloride 1 to 2 hours before drinking. However, administration is limited to once daily. The dose may be increased to 20 mg based on symptoms.

Outcome(s)

Primary Outcome	heavy drinking days (HDD), (alcohol intake of 60 g/day or more for men, 40 g/day or more for women)
Secondary Outcome	1. total alcohol consumption (TAC), DRL (Drinking Risk Level), OCDS (obsessive compulsive drinking scale) 2. Adverse events 3. Development of physical complications due to alcohol, such as cancer and cirrhosis.

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 65age old
Gender	Both
Include criteria	1. Individuals aged 20 to 65 years at the time of consent acquisition 2. Individuals who, after receiving sufficient explanation regarding participation in this study, provided written consent based on their own free will following full understanding 3. Individuals meeting the DSM5 diagnostic criteria for alcohol dependence 4. Individuals with a blood alcohol concentration (BAC) of 0.1 mg/dL at the time of hospital visit (i.e., not intoxicated) 5. Having a high or very high drinking risk level (DRL), Alcohol intake of 60 g or more per day (equivalent to 1500 ml of beer for men) or 40 g per day (equivalent to 1000 ml of beer for women).
Exclude criteria	1. During the 4 week screening period, heavy drinking days (HDD) were fewer than 6 days, with alcohol intake of 60 g/day or more (men) and 40 g/day or more (women). 2. During the 4 week screening period, abstinence was maintained for 5 days or more. 3. History of treatment within the 4 week screening period for alcohol self help groups, alcohol detoxification therapy, or alcohol withdrawal states. 4. Score of 10 or higher on the Modified Clinical Institute Withdrawal Assessment for Alcohol (CIWA Ar) alcohol withdrawal syndrome scale. 5. Comorbid diagnosis of a mental disorder other than alcohol dependence (e.g., schizophrenia, mood disorder, anxiety disorder, dementia, mental retardation). 6. Patients at high suicide risk (C SSRS suicidal ideation score more than 4, active suicidal thoughts with some intention to act but no concrete plan; or score more than 5, suicide attempt within the past 2 years). 7. Patients with comorbid epilepsy. 8. Patients with a history of alcohol withdrawal delirium or alcohol withdrawal seizures. 9. Individuals with inadequate blood glucose control 10. Patients with undergoing treatment for diabetes 11. Patients with taking sulfonylureas, insulin, glinides, or dipeptidyl peptidase-4 (DPP-4) inhibitors 12. Clinically significant and unstable patients (e.g., those with NYHA Class III or higher heart failure/angina, renal impairment with eGFR below 30 mL/min/1.73 mm2, liver failure, or malignant neoplastic disease). 13. Patients with a BMI below 23 14. Patients with screening test results showing: red blood cells below 3 million/mm3, Hb below 9.5 g/dL, white blood cells below 3,000/mm3, platelets below 75,000/mm3, or AST/ALT levels exceeding 3 times the upper limit of normal 15. Patients positive for hepatitis B virus, hepatitis C virus, or HIV 16. Pregnant patients or patients with a possibility of pregnancy 17. Other patients deemed unsuitable as study subjects by the principal investigator or subinvestigator