A multicenter randomized, open-label trial to assess the efficacy and safety of the digital therapeutics ALM-003 for alcohol dependence

CureApp, Inc0 个研究点目标入组 260 人开始时间: 2023年2月6日最近更新: 2023年9月27日

适应症

试验速览

暂无简介。

•We will include people who meet all the following criteria:
•20 years of age or older
•diagnosed with alcohol dependence according to ICD-10
•High or Very High Drinking Risk Level during screening period (from week -4 to week 0)
•Can be treated on outpatient clinics
•No serious social or family problems due to drinking
•No life-threatening organ failures
•CIWA-Ar score < 10 at week -4 and week 0
•Agree to participate in the present study
•Accustomed to use a smartphone with iOS 14.0 or higher or Android 10 or higher

•We will not include people who meet any of the following criteria:
•< 6 heavy drinking days (HDD) during the screening period
•5 consecutive no drinking days during the screening period
•Diagnosed with dementia or intellectual disability
•Has participated in any structured treatment for alcohol dependence, structured programs for drinking moderation, or self-help groups during the 4 weeks prior to week -4
•Concomitant use of medications for alcohol dependence during the 4 weeks prior to week -4
•Has participated in any intervention study during the 4 weeks prior to week -4
•Has participated in a preliminary study of the prior version of ALM-003
•Judged to be at high risk of suicide by investigators or PHQ-9 item 9 (suicidal thoughts) is 1 or more at week -4
•Female with pregnancy or expecting
•No fixed address or telephone number
•Judged to be inappropriate as a participant by investigators

Change in HDD from baseline to week 12

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发起方

CureApp, Inc