Alcoholism and the Development of Therapeutic Apps

Data Accumulation from Widespread Use of Digital Therapeutics Contributes to Facilitating Research and Policy Making 

Alcoholism
Excessive consumption of alcohol causes a variety of problems. Specifically, it is associated with a higher risk of causing accidents, decreased productivity in the workplace, increased medical and mental health costs, and higher rates of crime and violence. It is estimated in Japan that around 260,000 suspected alcoholics, 40,000 people with alcoholism under treatment and more than 540,000 people have previously met the diagnostic criteria. Furthermore, while 22% of those suspected of having such a diagnosis have a history of specialized treatment, 83% have visited a general medical institution, including internal medicine, for some reason within a year. It is a significant treatment gap. ^１)

The Basic Law on Alcohol Health Disorders and the new Diagnosis and Treatment Guidelines for Alcohol and Drug Use Disorders²⁾ promote early intervention in internal medicine based on the history of visits to general medical institutions, even though visits to specialized treatment institutions are rare. However, psychotherapy may be available only in a limited number of facilities due to the difficulty of acquiring the necessary skills and time to implement it. In addition, prejudice against substance-dependent patients has hindered its widespread practice.

For example, if a patient begins treatment after several years of serious illness, treatment is often long-term. In my own experience, although I have often referred patients to specialized institutions as a non-psychiatrist in actual clinical practice, it is rare for a psychiatrist to receive such a referral as an initial outpatient visit at a general psychiatric institution. Most patients are diagnosed as cases requiring emergency psychiatric care or suspected of having other psychiatric disorders, such as mood disorders, which are found as comorbidities and treated during examination and treatment.

Current pharmacotherapy and behavioral therapy, a form of psychotherapy, help reduce or eliminate alcohol consumption. In particular, pharmacotherapy has been reported to be more effective when combined with behavioral interventions. ³⁾

Psychotherapy for alcoholism is diverse, and one of the most effective treatments is an intervention based on motivational interviewing. These include self-monitoring, situational awareness in the context of risky alcohol use, and social skills training to maximize the effectiveness of treatment according to the patient’s characteristics.

There is also a movement to address these issues in the disease areas presented here through the Internet and mobile health interventions.
Digital therapy interventions have been suggested to be effective in reducing the frequency of hazardous post-treatment alcohol use and maintaining sobriety. ⁴⁾ Their introduction is also expected to reduce time and human labor costs while maintaining the quality of treatment.

Therapeutic Apps Intended for Use in Non-Specialized Medical Institutions
To lower the barriers to treatment in Japan and increase early intervention, a company is developing and conducting clinical trials of digital therapies that can be used in specialized medical institutions and internal medicine to treat mild cases of alcohol dependence. That is CureApp, Inc.（hereinafter CureApp）’s therapeutic app for alcohol dependence. ^５) It has the potential to help support independent community living by providing more robust ongoing care that is useful for improving and maintaining medical conditions.

The company is developing the app as SaMD Class II based on methods recommended in treatment guidelines. It introduces the app as a treatment that reinforces individualized patient care outside of the office visit. It could also be proposed as an easily accessible treatment method for patients resistant to existing psychosocial treatment delivery methods. Another advantage is that it will allow patients to receive care that is not currently reimbursed in Japan’s public healthcare insurance system but is desirable from a therapeutic standpoint at a reduced time and physical cost.

Development Status
A feasibility study began in 2020 to confirm the acceptability of CureApp’s app and found favorable reductions in alcohol consumption and frequency. A multicenter, open-label, random control trial started in 2021 at three internal medicine hospitals as a preliminary clinical trial. ^６) The data collection for the primary endpoint has been completed, and a validation trial under GCP will be conducted in 2023, leading to regulatory approval and insurance coverage. ^７)

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