UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000031589
Receipt No. R000033555
Scientific Title A randomized controlled trial of CA-F17 in standard smoking cessation program for nicotine dependence
Date of disclosure of the study information 2018/03/14
Last modified on 2020/07/21 (Ver. 5)

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Basic information
Public title A randomized controlled trial of CA-F17 in standard smoking cessation program for nicotine dependence
Acronym A randomized controlled trial of CA-F17 in standard smoking cessation program for nicotine dependence
Scientific Title A randomized controlled trial of CA-F17 in standard smoking cessation program for nicotine dependence
Scientific Title:Acronym A randomized controlled trial of CA-F17 in standard smoking cessation program for nicotine dependence
Region
Japan

Condition
Condition nicotine dependence
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effect of CA-F17 in addition to the standard smoking cessation treatment program for nicotine dependence as compared with control application
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 9-24 week Continuous Abstinence Rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 One-time dispense of CA-F17 in conjunction with 3 months of Standard Treatment of Nicotine Dependence
Interventions/Control_2 3 months of Standard Treatment of Nicotine Dependence
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cases using a smartphone, diagnosed as nicotine dependent in tobacco dependence screening test who intend to quit smoking immediately
Key exclusion criteria Cases judged difficult to participate in the trial, such as severe mental illness
Target sample size 580

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Tateno
Organization Keio University, School of Medicine
Division name Division of Pulmonary Medicine, Department of Medicine
Zip code 160-8582
Address 35 Shinanomachi, Shinjyuku, Tokyo
TEL 0333531211
Email hrk12tateno@me.com

Public contact
Name of contact person
1st name Tomoyasu
Middle name
Last name Muto
Organization CureApp, Inc.
Division name Clinical and Regulatory Affairs Department
Zip code 103-0001
Address 12-5, Kodenmacho, Nihobashi, Chu-o-ku, Tokyo
TEL 03-6231-0183
Homepage URL
Email clinreg_admin@cureapp.jp

Sponsor
Institute CureApp, Inc.
Institute
Department

Funding Source
Organization CureApp, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University Hospital Institutional Review Board
Address 35 Shinanomachi, Shinjyuku, Tokyo
Tel 0333531211
Email keio-chiken@adst.keio.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 1 Ankou Medical Clinic Tokyo
2 Ayano Clinic Saitama
3 BOOCS Clinic Fukuoka Fukuoka
4 Chuo Naika Clinic Tokyo
5 Ebisu Garden Place Clinic Tokyo
6 Higashi-hie Naika Fukuoka
7 Hosoda Shinryojo (clinic) Tokyo
8 Inoue Naika Clinic Ibaraki
9 Kanda Clinic Tokyo
10 Keio University Hospital Tokyo
11 Kimura-Shiro Clinic Fukuoka
12 Kita Shin-Yokohama Naika Clinic Kanagawa
13 Mashiba Iin (clinic) Saitama
14 Maekawa Medical Clinic Kanagawa
15 Miyazaki RC Clinic Tokyo
16 Motosumiyoshi Kokoromi Clinic Kanagawa
17 Nakameguro Atlas Clinic Tokyo
18 National Center for Global Health and Medicine Tokyo
19 Nemoto Geka-Seikeigeka (clinic) Saitama
20 Nihonbashi Naika-Allegy Clinic Tokyo
21 Nomura Iin (clinic) Tokyo
22 Odayaka Life Naika Clinic Saitama
23 Saitama City Hospital Saitama
24 Sawayama Naika-Sougoushinryou Clinic Fukuoka
25 Segawa Hospital Saitama
26 Shimizu Clinic Fusa Saitama
27 Shinjuku Research Park Clinic Tokyo
28 Sone Clinic Shinjuku Tokyo
29 Tajima Clinic Tokyo
30 Tenjin Sogo Clinic Fukuoka
31 Ueda Naika Clinic Fukuoka

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 14 Day

Related information
URL releasing protocol https://www.researchprotocols.org/2019/2/e12252/
Publication of results Published

Result
URL related to results and publications https://www.nature.com/articles/s41746-020-0243-5
Number of participants that the trial has enrolled 584
Results 
Continuous abstinence rate from weeks 9 to 24？in the intervention group was significantly higher than that in the control group (63.9% vs. 50.5%; odds ratio [OR], 1.73; 95% confidence interval [CI], 1.24 to 2.42; P？=？0.001).
Results date posted
2020 Year 07 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 03 Month 12 Day
Baseline Characteristics 
We randomized a total of 584 eligible participants. Of all the participants, 12 did not download or never used either of the apps. Thus, 285 participants allocated to the CASC group and 287 participants assigned to the control group were included in the full analysis set. The participants mean age was 46 years, and 75% were male. The median of the pack years was 20. There were no significant differences in baseline characteristics between the two groups.
Participant flow 
Randomization was performed for eligible participants. They were allocated 1:1 to both arms the CASC treatment group and the control app group. Randomization was performed by a computer-generated random sequence with stratification for smoking cessation medications.
Adverse events 
In all, 67.4% (192/285) of the CASC group and 63.8% (183/287) of the control had treatment-emergent adverse events, including viral upper respiratory tract infections (20.4% in the intervention group vs. 12.9% in the control), nausea (18.6% vs. 22.3%), influenza (6.0% vs. 3.5%), headache (5.3% vs. 4.2%), constipation (4.9% vs. 5.6%), insomnia (4.6% vs. 2.8%), weight gain (3.9% vs. 2.4%), somnolence (3.5% vs. 5.9%), abdominal discomfort (3.2% vs. 2.1%), and/or contact dermatitis (2.8% vs. 3.1%).
Outcome measures 
The primary outcome was the biochemically validated continuous abstinence rate (CAR) from weeks 9 to 24.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 08 Month 14 Day
Date of IRB
2017 Year 09 Month 14 Day
Anticipated trial start date
2017 Year 10 Month 17 Day
Last follow-up date
2019 Year 01 Month 10 Day
Date of closure to data entry
2019 Year 01 Month 14 Day
Date trial data considered complete
2019 Year 02 Month 10 Day
Date analysis concluded
2019 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 05 Day
Last modified on
2020 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033555