臨床研究等提出・公開システム

An open-label, randomized, parallel-group trial to examine the feasibility of implementing a software as medicine for alcohol dependence

Therapeutic apps for control drinking or abstinence: A feasibility randomized controlled study

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In this study, the average age of the participants was 55 years old, with 21 individuals classified under the WHO Drinking Risk Level High category, 22 individuals in the Very High category, 27 males, and 16 females.

The enrollment of study participants commenced in June 2021 and was completed in January 2022. Out of the 43 participants, 38 attended the visit at week 12, when the primary endpoint was evaluated.

Adverse events occurred in the intervention group with 13 types and a total of 19 cases, while in the control group, 11 types and a total of 11 cases were reported.

The between group difference in the primary efficacy endpoint, the number of heavy drinking days per 28 days at Week 12, was 6.99 days/28 days (95% confidence interval 1.60 to 12.38 days/28 days). In addition, the safety analysis showed no adverse events attributed to the use of ALMIGHT App.

The pilot study preliminarily showed that ALMIGHT App was likely to be efficacious without any serious adverse events. A larger and more rigorously designed trial is needed to confirm these findings.

May. 31, 2024

July. 17, 2024

https://www.sciencedirect.com/science/article/abs/pii/S0163834324001579?via%3Dihub

No

No plan to share IPD

https://jrct.mhlw.go.jp/latest-detail/jRCTs062210005

NOUSO Kazuhiro

Okayama City General Medical Center, Okayama City Hospital

3-20-1,Kitanagaseomotemachi, Kita-ku, Okayama-city

kazuhiro_nouso@okayama-gmc.or.jp

KARIYAMA Kazuya

Okayama City General Medical Center, Okayama City Hospital

3-20-1,Kitanagaseomotemachi, Kita-ku, Okayama-city

+81-86-737-3000

kariyama777@gmail.com

Complete

May. 25, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1.A person who is 20 years of age or older at the time of obtaining the consent
2.A person diagnosed with alcohol dependence
3.A person who has high or very high DRL (average daily alcohol intake is more than 60g for men and 40g for women during the past 14 days at each time point) both at screening and at the start of the intervention
4.A person who could be treated in an outpatient setting
5.A person who has not had serious difficulties in social and family life caused by drinking
6.A person who has not had life-threatening or serious organ damage because of drinking
7.A person who has not had alcohol withdrawal symptoms (such as hallucinations, convulsions, and tremors) that require any urgent treatments
8.A person who has given the consents for participating in this study by their free will after being fully informed and understanding about this study
9.A person who can communicate with clinical trial staffs
10.A person who is willing to undergo the intervention at predetermined times and procedures and use the device under study
11. A person who uses smartphone on a daily basis

1.A person who had less than 6 heavy drinking days (HDDS: days drinking more than 60g for men and 40g for women ) in the four weeks before screening
2.A person who had five consecutive days with not drinking alcohol in the four weeks before screening
3.A person who underwent alcohol dependence treatment or participated in the support program for reducing alcohol intake or self-help group in the 4 weeks before screening
4.A person who received other structured psychotherapy in the four weeks before screening
5.A person with the complications of dementia and intellectual disability
6.A person who took concomitant prohibited drugs in the 4 weeks before screening
7.A person with a significant suicidal ideation at screening or at the start of the intervention
8.A person determined to have significant suicide risk by the principal investigator or sub-physician
9.A person who participated in any clinical trials in the four weeks before screening
10.A person who does not have a fixed address and phone number
11.A person who does not use an iPhone with iOS14.0 or later or Android with version 10 or later on a daily basis
12.A person who the principal investigator or sub-physician considered unsuitable as a subject.

Both

alcohol dependence

Intervention using a software as medical device (SaMD) or a paper-based treatment support tool for 24 weeks

alcohol dependence

application, treatment support tool

D000437

D015928, D013672

The change in the number of HDD(heavy drinking day) per week from 0 week to 4, 8, 12 weeks

1.The change in the number of HDD per week from 0 week to 4, 8, 12, 24 weeks
2.The change in the average of total alcohol consumption per week from 0 week to 4, 8, 12 weeks and from 0 week to 4, 8, 12, 24 weeks.
3.The change in AUDIT score and ADS score from 0 week to 12, 24 weeks.
4.The change in AQoLs score from 0 week to 12, 24 weeks.
5.The change in ERQ score and SBI score from 0 week to 12, 24 weeks.
6.The change in blood test results from 0 week to 12, 24 weeks.
7.The number of adverse events

+81-86-235-7133

April. 27, 2021

none