Information Materials

Instructions for use (eIFU), intended use, indications, warnings and compatibility for AlcoChange v2.3.5

ⓘ Intended Use

AlcoChange is a prescription-only digital therapeutic intended to support the reduction of alcohol use and the maintenance of abstinence in adults (aged 18 years or over) with established alcohol-related liver disease (ARLD). It is used as an adjunct to standard clinical care, under the supervision of a qualified clinical team, and does not replace standard clinical care. AlcoChange delivers behavioural change interventions and provides information used by the clinical team to monitor the patient's behavioural risk (relapse and disengagement) during treatment.

+ Indications for Use

AlcoChange is indicated as a 90-day, prescription-only treatment for adults (aged 18 years or over) with established ARLD who are enrolled in outpatient or community care under the supervision of a qualified clinical team. It provides behavioural therapy based on the CyberLiver Behaviour Change (CBC) Model, using personalised digital behaviour change techniques and behaviour change notifications, and presents behavioural-risk and engagement information, together with validated questionnaire outputs, to the supervising clinician for review.

⚠ Contraindications

Absolute contraindications (do not use AlcoChange if any apply):

  • Under 18 years of age
  • No established diagnosis of alcohol-related liver disease (ARLD)
  • Not under the supervision of a qualified clinical team
  • Unable to understand or follow the instructions for use

Relative contraindications (use only under clinical judgement):

  • Severe cognitive impairment that prevents meaningful engagement with the application
  • Fewer than 3 to 4 interactions per week with the application, sustained over the treatment period, which may reduce the effectiveness of the behavioural change interventions

⚠ Warnings and Precautions

  • AlcoChange does not replace standard clinical care. It is intended to be used as an adjunct to care delivered by a qualified clinical team.
  • AlcoChange does not provide emergency medical advice. If you are experiencing a medical emergency, contact 999 or attend your nearest Accident and Emergency department.
  • If you are experiencing thoughts of self-harm or suicide, please contact 999 or 111 immediately. AlcoChange signposts to these services but does not provide crisis intervention.
  • AlcoChange is not a substitute for pharmacological treatment of alcohol dependence or withdrawal. Clinical decisions regarding medication remain the responsibility of the supervising clinical team.
  • The digital breathalyser (ADBII) provides a qualitative alcohol present or absent indication only. It is not a measuring device and must not be relied upon for quantitative blood-alcohol assessment or legal purposes.
  • AlcoChange requires an active internet connection to function. Functionality may be limited or unavailable in areas with poor connectivity.
  • Patients should not share their AlcoChange account credentials with any other person.
  • Clinical oversight notifications generated by AlcoChange are for informational purposes. All clinical decisions remain the responsibility of the supervising clinical team.

Instructions for Use (eIFU)

Download the full instructions for use for AlcoChange v2.3.5

Document Version Date Download
AlcoChange Patient Instructions for Use v3.2 September 2026 Download PDF
AlcoChange Clinician Dashboard Instructions for Use v2.15 September 2026 Download PDF

📱 Compatibility

  • iOS 15 or later
  • Android 10 or later
  • An active internet connection is required
  • Optional: compatible Bluetooth digital breathalyser (ADBII), for indoor use only

🏭 Manufacturer

CyberLiver Limited
Devonshire House, 582 Honeypot Lane, Stanmore, HA7 1JS, United Kingdom

UKCA 0120 MD

Notified Body: SGS United Kingdom Ltd (0120)