NIHR-funded NHS randomised controlled trial ISRCTN 10911773

AlcoChange Clinical Trial
for Alcohol-Related Liver Disease

A multi-centre NHS randomised controlled trial evaluating whether the AlcoChange digital therapeutic, used alongside usual specialist care, can help people with alcohol-related liver disease maintain abstinence or significantly reduce their alcohol use.

MHRA registered UKCA Class IIa Medical Device

Collaborators

NIHR

Funder – NIHR Invention for Innovation (i4i) Programme

University of Southampton

Sponsor – University of Southampton

Southampton CTU

Coordinating Centre – Southampton Clinical Trials Unit

UCL

Academic Partner – UCL

LSHTM

Health Economics – London School of Hygiene & Tropical Medicine

CyberLiver

Digital Health Innovator – CyberLiver Limited

NHS

Participating NHS Hospitals & Alcohol Care Teams

Map of participating NHS sites

About the AlcoChange Clinical Trial

The AlcoChange clinical trial evaluates whether a regulated digital therapeutic can support adults with alcohol-related liver disease in maintaining abstinence or significantly reducing their alcohol consumption, alongside usual specialist liver care.

The trial was conducted across NHS hospitals in the UK with specialist hepatology or liver services. Participants were adults with alcohol-related liver disease who had recently had an alcohol-related clinical encounter, were advised to maintain abstinence.

Participants were individually randomised to receive either AlcoChange plus standard care or standard care alone, with outcomes assessed over a 6-month follow-up period.

The AlcoChange Digital Therapeutic (DTx)

AlcoChange DTx, an MHRA-cleared, UKCA Class IIa–marked digital therapeutic for Alcohol-related Liver Disease (ArLD), delivers a proprietary, evidence-based behavioural therapy framework to manage cravings, support abstinence or reduced alcohol intake, enhance patient engagement, and achieve improved clinical and economic outcomes. Developed to close the care gap where fewer than 10% of patients currently receive treatment, AlcoChange DTx drives measurable adherence and sustained behaviour change.

  • Personalised digital behaviour change interventions (DBCIs) focused on maintaining abstinence and improving behaviour.
  • Multiple Digital Behaviour Change Techniques (DBCTs) deliver structured support in real-time throughout the therapy duration.
  • Relapse prevention and engagement strategies to improve treatment adherence.

The AlcoChange trial is one of the first large-scale evaluations of a regulated digital therapeutic specifically targeted at patients with established alcohol-related liver disease across NHS services.

Personalised therapy

Goal-oriented reminders and digital behaviour-change content aligned with patients' abstinence or reduction plans, delivered at key risk moments.

Digital breathalyser support

Integration with a connected breathalyser to capture objective breath alcohol results for those issued a device, alongside self-reported abstinence or alcohol use.

Support integration

Designed to complement, not replace, specialist liver care and community alcohol services, with data summaries available to clinical teams.

Data for service planning

Anonymised engagement and outcome data can inform future digital pathways and service models for alcohol-related liver disease.

Regulatory Certifications & Compliance

Regulatory certifications including UKCA 0120, ISO 13485, IEC/ISO 62304, IEC 82304-1, ISO 14971, ISO 14155, DCB 0129, Cyber Essentials, and NHS Data Security and Protection Toolkit

Trial Coordination and Governance

The AlcoChange clinical trial is conducted in accordance with NHS research governance frameworks and Good Clinical Practice, with independent oversight committees and a recognised UK Clinical Trials Unit.

Trial management and oversight

  • Central trial coordination by Southampton Clinical Trials Unit (SCTU).
  • Independent Trial Steering Committee and Data Monitoring Committee.
  • Site Principal Investigators at each participating NHS Trust / hospital.

Sponsor and funder

The AlcoChange clinical trial is funded by the NIHR Invention for Innovation (i4i) Programme (NIHR201002) and is sponsored by University of Southampton.

Economic evaluation & health economics

For queries related to the health economic analysis or cost-effectiveness modelling, please contact:

Dr Zia Sadique
London School of Hygiene & Tropical Medicine
zia.sadique@lshtm.ac.uk

Important contacts

Media enquiries:
Ravi Kumar (CyberLiver Ltd)
ravi.kumar@cyberliver.com

Chief Investigator:
Dr Gautam Mehta (UCL / Royal Free Hospital)
gautam.mehta@ucl.ac.uk

Southampton Clinical Trials Unit:
alcochange@soton.ac.uk

CyberLiver / patient support:
info@cyberliver.com

Press & media

Official announcements and external media coverage related to the AlcoChange digital therapeutic and NIHR-funded clinical trial.

Official CyberLiver Press Releases

Media & information requests

For media enquiries about the AlcoChange clinical trial, please contact Ravi Kumar (CyberLiver Ltd) at ravi.kumar@cyberliver.com.

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In the News & Media

New app encourages sobriety

Royal Free London · January 2024

Royal Free London feature on AlcoChange and its use in patients with alcohol-related liver disease.