alcohol dependence alcohol dependence
Conditions
Interventions
Intervention using a software as medical device (SaMD) or a paper-based treatment support tool for 24 weeks
D015928, D013672
application, treatment support tool
Sponsors
NOUSO Kazuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the number of HDD(heavy drinking day) per week from 0 week to 4, 8, 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactKazuya KARIYAMA
Okayama City General Medical Center, Okayama City Hospital
Outcome results
None listed