Clemastine Fumarate for Alcohol Use Disorder

Phase 1

Recruiting

• Conditions: alcohol dependence or alcohol use disorder; Alcohol use disorder; D000437

• Registration Number: JPRN-jRCTs041220020
• Lead Sponsor: Kishi Taro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified