Patient Instruction for Use

MODIA is available for clinical use under the direction of a healthcare professional during the COVID-19 Public Health Emergency under FDA’s Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders (not FDA-cleared).

The therapeutic content provided through MODIA is not intended as a substitute for treatment provided by a clinician.

Intended Use:

MODIA is intended to provide digital cognitive behavioral therapy for patients who have been diagnosed with opioid use disorder (OUD).

Indication for Use:

MODIA is intended to provide digital cognitive behavioral therapy for patients with opioid use disorder (OUD), 18 years of age or older, as a part of a clinician supervised medication-assisted treatment program for opioid use disorder (OUD). MODIA is a prescription only device to be ordered by a clinician.

What is MODIA?

MODIA is a web-based program that can be used at any time of the day for a length of 180 days on a mobile phone, tablet, or computer with an internet browser.

MODIA uses cognitive behavioral therapy (CBT) skills to treat individuals diagnosed with OUD. By engaging users in custom exercises, it aims to reduce symptoms of OUD. Each MODIA section focuses on relevant topics, such as learning about the short-term and long-term effects of using opioids, learning behavioral and mental skills to help with urges or cravings to use, learning problem solving skills, emotional regulation skills (eg, managing depression, anxiety, or anger), and recognizing possible signs of relapse.

The content in MODIA is delivered via brief messages with menus of response options, audio recordings, pictures, worksheets and summaries. MODIA also asks patients to complete two surveys to monitor progress.

MODIA can customize its interactions with users depending on the specific responses selected by the user. MODIA helps users develop a customized relapse prevention plan that includes risk-behaviors, triggers, cravings, and coping strategies based on the responses collected in the exercises.

Duration and Frequency of Use:

The usage period per access key is 180 calendar days after initial registration.

It is recommended for the individual to use MODIA 1-2 times per week for at least 15 minutes per session.

Operating Information and Setup Instructions

MODIA is an interactive, online-based program. Patient will need a computer, a laptop, a smartphone or a tablet with internet access as well as an up-to-date version of the browser Google Chrome, Mozilla Firefox, Edge or Safari. A minimal (logical) resolution of 320 × 568 pixel is recommended. Patient also needs an email address and optionally a mobile number for the text message service. For audio, a bandwidth of 192 kbit/s is recommended.

1.
A licensed clinician can order MODIA via a company-provided portal, and will require an email address for the patient.
2.
Following the clinician order, the patient will be sent an individualized access code via e-mail.
Fig.1: Voucher activation
3.
Users will enter the access code, then set a username and password to use for logins. User registration will also include information for the “forgot username/password” function.
Fig.2: Registering the log-in personal data

4.
Once registered, MODIA guides users through the program and no special computer skills are required. MODIA provides an overview of the program, after which the user begins working and learning with MODIA, completing the exercises as directed by the program.
Fig.3: Representative interactive dialogue in MODIA
The program will track progress and guide the user through the exercises of the program. Each exercise informs the user when the session is completed. All information entered is private to the user.
The user will also receive emails or text messages encouraging use of the information and encouraging practice into daily routines.

Security

MODIA includes an individual access code and personal user ID to ensure that the user’s experience is private and confidential.

Personal data will not be given to third parties nor be used for marketing purposes. Data is saved according to data protection rules. Data transfer for the use of the product takes place over a secure internet connection; details are encrypted by Secure Sockets Layer (SSL).

MODIA is not installed on the end device nor is any data stored on the end device.

Safety Information

Adverse Events:

The likelihood of adverse events, or undesirable outcomes is low. However, emotional reactions like frustration or other distressing emotions if the content is found to be confusing, overwhelming, or unsuitable, may occur when using MODIA.

Patients should inform their healthcare professional immediately in the event of any side effects while using MODIA.

Please inform us via email to modia@broca.io about potential adverse events.

General Warnings and Precautions:

Progress with MODIA is based on many factors, and it is possible that not everyone will benefit from using this program. In case of no noticeable improvement in your clinical condition, please consult your healthcare provider.

Not every exercise or every recommendation is equally suitable for everyone. Therefore, an exercise or recommendation may be difficult, cause discomfort, or worsen complaints. If any of these occur while working with the program, please take a break, stop using the program, and talk to your healthcare provider.

MODIA is not intended to replace current treatment. Continue to take medications as directed.

MODIA is not a substitute for clinical care administered by a qualified healthcare professional.

The use of MODIA for opioid use disorder has not been clinically tested and therefore may have unknown benefits and risks.

Information for Emergencies

In the event of a medical or mental health emergency contact 9-1-1 or go to the nearest emergency room.

Additional Support Available

Patient support representatives will be available to assist with reimbursement or product access questions upon request. The program can be accessed via phone at 1.833.30MODIA.

In case of technical issues, questions can be sent to modia@broca.io. The support team can help within usual working hours.

Please note that the technical support is not intended for medical questions and a qualified healthcare provider should be consulted in case of clinical issues.

Additional Related Resources

SAMHSA’s (Substance Abuse and Mental Health Services Administration) National Helpline, 1-800-662-HELP (4357), (also known as the Treatment Referral Routing Service) or TTY: 1-800-487-4889 is a confidential, free, 24-hours a day, 365 days a year, information service, in English and Spanish, for individuals and family members facing mental and/or substance use disorders. This service provides referrals to local treatment facilities, support groups, and community-based organizations. Callers can also order free publications and other information.

The National Suicide Prevention Lifeline is a national network of local crisis centers that provide free and confidential emotional support to people in suicidal crisis or emotional distress 24 hours a day, 7 days a week. Call 1-800-273-8255 or visit www.suicidepreventionlifeline.org for further information.

Distributed by Orexo US, Inc

Morristown, NJ 07960 USA

MODIA is a licensed trademark of Orexo US, Inc.

Manufactured by GAIA AG

Hans-Henny-Jahnn-Weg 53 22085

Hamburg Germany

Instructions for Use Version: v02 (03/21)

Software Version:

Please refer to the legal notice of MODIA under the menu item “Help” for details of the current software version.