臨床研究等提出・公開システム

Date of registration	Jan. 07, 2023
Last modified on	Sept. 27, 2023
Trial ID	jRCT2032220560

Scientific Title	A multicenter randomized, open-label trial to assess the efficacy and safety of the digital therapeutics ALM-003 for alcohol dependence
Public Title	A clinical trial of a therapeutic application ALM-003 for alcohol dependence

Contact for Scientific Queries	Name	So Ryuhei
	Affiliation	CureApp, Inc
	Address	Kodenma-Cho YS building 4th floor 12-5, Nihonbashi Kodenma-Cho, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6231-0183
	E-mail	alm-clin-reg@cureapp.jp
Contact for Public Queries	Name	Shishido Asuka
	Affiliation	CureApp, Inc
	Address	Kodenma-Cho YS building 4th floor 12-5, Nihonbashi Kodenma-Cho, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6231-0183
	E-mail	alm-clin-reg@cureapp.jp

Recruitment status	Complete

Anticipated date of first enrollment		Jan. 07, 2023
Actual date of first enrollment		Feb. 06, 2023
Target sample size		260
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	We will include people who meet all the following criteria: 1) 20 years of age or older 2) diagnosed with alcohol dependence according to ICD-10 3) High or Very High Drinking Risk Level during screening period (from week -4 to week 0) 4) Can be treated on outpatient clinics 5) No serious social or family problems due to drinking 6) No life-threatening organ failures 7) CIWA-Ar score < 10 at week -4 and week 0 8) Agree to participate in the present study 9) Accustomed to use a smartphone with iOS 14.0 or higher or Android 10 or higher
	Exclusion Criteria	We will not include people who meet any of the following criteria: 1) < 6 heavy drinking days (HDD) during the screening period 2) 5 consecutive no drinking days during the screening period 3) Diagnosed with dementia or intellectual disability 4) 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 5) Concomitant use of medications for alcohol dependence during the 4 weeks prior to week -4 6) Has participated in any intervention study during the 4 weeks prior to week -4 7) Has participated in a preliminary study of the prior version of ALM-003 8) Judged to be at high risk of suicide by investigators or PHQ-9 item 9 (suicidal thoughts) is 1 or more at week -4 9) Female with pregnancy or expecting 10) No fixed address or telephone number 11) Judged to be inappropriate as a participant by investigators
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Alcohol dependence
Intervention(s)		Intervention group: ALM-003 adjunct to treatment as usual for 24 weeks Control group: a simple drink diary app and psychoeducation material adjunct to treatment as usual (enhanced treatment as usual) for 24 weeks
Primary Outcome(s)		Change in HDD from baseline to week 12

Primary Sponsor	CureApp, Inc

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	Yoyogi Mental Clinic IRB
Address	4-26-11 Sendagaya,Shibuya-ku,Tokyo 151-0051 Japan, Tokyo
Telephone	+81-3-6804-2227
E-Mail	cns_jimu@triad-j.co.jp
Approval Status	Approval
Date of approval	Dec. 05, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Sept. 27, 2023	(this page)	Changes
3	April. 04, 2023	Detail	Changes
2	Feb. 12, 2023	Detail	Changes
1	Jan. 07, 2023	Detail

List of change history