None listed
Conditions
Interventions
Medical Device, Behavioral : The intervention group will receive an 8-week treatment using the digital therapeutic device, Dr.Jin Nicojini, which is based on non-pharmacological treatment for nicotine
Sponsors
Innerwave Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged between 19 and 70 years. 2) Individuals diagnosed with nicotine addiction (or dependence) according to the International Classification of Diseases, 10th Revision (ICD-10), including F17 (Mental and behavioral disorders due to use of tobacco), T65.2 (Toxic effect of tobacco and nicotine), U07.0 (Vaping-related disorders), X97 (Assault by tobacco), Z58.7 (Exposure to tobacco smoke), Z71.6 (Tobacco abuse counseling), Z72.0 (Tobacco use), or Z81.2 (Family history of tobacco abuse). 3) Individuals who have no difficulty in reading and writing the Korean language. 4) Individuals capable of using mobile applications on universal smart devices (e.g., smartphones or tablet PCs) without difficulty. 5) Individuals who have received a full explanation of the clinical trial, understand the study procedures, and voluntarily provide written informed consent to participate and comply with the study requirements.
Exclusion criteria
Exclusion criteria: 1) Individuals diagnosed with Substance-Related and Addictive Disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), other than nicotine addiction (Note: Caffeine-related disorders are not considered an exclusion criterion). 2) Individuals exhibiting symptoms of schizophrenia spectrum disorders, or those diagnosed with bipolar disorder or experiencing symptoms of a major depressive episode at the time of the baseline assessment. 3) Individuals who have attempted suicide within the last 3 months or are determined by medical staff to be at high risk for suicide. 4) Individuals who have initiated or are currently undergoing other psychosocial treatments, such as Cognitive Behavioral Therapy (CBT) or Motivational Enhancement Therapy (MET), within the last 3 months (Note: This includes all types of psychosocial interventions for nicotine addiction or other conditions). 5) Individuals with visual or hearing impairments, or those with cognitive impairments (e.g., dementia). 6) Individuals who have difficulty in listening, writing, or speaking the Korean language. 7) Individuals deemed unsuitable for participation in the clinical trial by the Principal Investigator for any other clinically significant reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7-day point prevalence abstinence at Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 7-day point prevalence abstinence;Continuous abstinence rate;Change in nicotine dependence;Change in nicotine dependence and craving;Change in smoking self-efficacy;Change in nicotine consumption;Usability (convenience, satisfaction, and willingness to recommend);Willingness to pay | — |
Countries
Korea, Republic of
Contacts
Public Contactjisum=n KIM
Hallym University Medical Center
Outcome results
None listed