NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000056621

Registered date:06/01/2025

The development and effectiveness of brief interventions for alcohol delivered by community pharmacists

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedPatients who have been prescribed antihypertensive drugs or oral diabetes drugs, regularly receive medication at the research-participating pharmacy (for more than 3 months), and are scored 8-14 on the AUDIT (Alcohol Use Disorders Identification Test).
Date of first enrollment2025/01/20
Target sample size231
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Intervention Group A: In addition to the regular medication guidance, provision of 90 bottles of 350mL non-alcoholic beverages (30 bottles, 3 times) and brief interventions for drinking by a pharmacist for 3 months. Intervention Group B: In addition to the regular medication guidance, provision of 18 bottles of 350mL non-alcoholic beverages (6 bottles, 3 times) and brief interventions for drinking by a pharmacist for 3 months, with an additional 6 bottles provided to those who wish after 3 months. Control Group: Regular medication guidance only. After the end of the 3-month waiting period, 24 bottles of 350mL non-alcoholic beverages and materials for drinking reduction support are provided to those who need.

Outcome(s)

Primary OutcomeChange in weekly amount of alcohol intake from baseline to 3 months later(g)
Secondary OutcomeAUDIT, AUDIT-C, Body weight(kg), BMI, Blood pressure(mmHg), HbA1c, Blood glucose level, WBC, RBC, Hemoglobin, Hematocrit, MCV, AST, ALT, Gamma-GTP Change in weekly amount of alcohol intake from baseline to 6 months later(g) Prescription medication information Knowledge, motivation, and attitudes about the impact of alcohol on health in research participants Knowledge, confidence, and attitudes about drinking reduction support in research participating pharmacists

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) People who are receiving treatment for alcohol problems 2)People who are participating in other alcohol-related studies 3)Dialysis patients 4)Pregnant or breastfeeding individuals 5)People who are taking psychiatric medications such as antidepressants, anti-anxiety drugs, antipsychotics (excluding sleep-inducing drugs) 6)People who cannot visit the pharmacy continuously for the research period of 3 months 7)People who do not agree to be contacted by the pharmacist by phone, email, etc. during the research period 8)Others who the principal investigator has judged to be unsuitable for research participation

Related Information

Contact

public contact
Name Kanae YASUI
Address 25-1, Shichi-bancho, Wakayama City, Wakayama Prefecture Japan 640-8156
Telephone 073-488-1843
E-mail yasui-k@wakayama-med.ac.jp
Affiliation Wakayama Medical University School of Pharmaceutical Sciences, Department of Social and Community Pharmacy
scientific contact
Name Hiroshi OKADA
Address 25-1, Shichi-bancho, Wakayama City, Wakayama Prefecture Japan
Telephone 073-488-1843
E-mail okada_h@wakayama-med.ac.jp
Affiliation Wakayama Medical University School of Pharmaceutical Sciences, Department of Social and Community Pharmacy