Clemastine Fumarate for Alcohol Use Disorder

JRCT ID: jRCTs041220020

Registered date:25/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: alcohol dependence or alcohol use disorder
• Date of first enrollment: 20/06/2022
• Target sample size: 5
• Study type: Interventional

Intervention(s)

Clemastine Fumarate administered orally between
Day1 and Day90, 1mg twice a day.

Outcome(s)

• Primary Outcome: (1) All-cause discontinuation rate

Secondary Outcome

(1) Change MMSE score from baseline to endpoint
(2) Change AUDIT score from baseline to endpoint
(3) Change ARRS score from baseline to endpoint
(4) Discontinuation rate due to adverse events Incidence of individual adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients over 20 years old.
(2) Patients for whom consent can be obtained.
(3) Patients with outpatients status.
(4) Patients diagnosed with alcohol dependence or alcohol use disorder based on ICD-11 or DSM-5 criteria.
(5) Patients with Mini-Mental State Exam score of 22 points or higher.
(6) Patients who have maintained total abstinence or who have reduced their alcohol consumption (based on the Japan treatment guideline.https://www.j-arukanren.com/pdf/20190104_shin_al_yakubutsu_guide_tebiki.pdf)
(7) Patients who have been abstinent or reduction of alcohol consumption for at least 1 month but 5 years or less since consent was obtained.

Exclude criteria

(1) Patient with cognitive impairment or intellectual disability due to other than alcohol use disorder.
(2) Patient with pregnant, lactating or planning pregnancy.
(3) Patients who engaged in operating hazardous machinery.
(4) Patients with hypersensitivity to clemastine fumarate.
(5) Patients with angle closure glaucoma or open angle glaucoma.
(6) Patients with obstructive disorders in the lower urinary tract.
(7) Patients with stenotic gastrointestinal ulceration or pyloric duodenal obstruction.
(8) Patients with convulsive disorder.
(9) Patients with AST, ALT, ALP, LDH or gamma-GTP >= 2.5 xULN.
(10) Patients who deemed ineligible as determined by the principal investigator or a co-investigator.

Related Information

• Primary Sponsor: Kishi Taro