Clinical Trial

Development and Evaluation of a Theory and Evidence-based Intervention to Reduce Hazardous Alcohol Consumption Among Treatment Seeking Smokers

Completed
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Summary
This study will evaluate the implementation of a fully automated, direct-to-patient digital alcohol intervention embedded within the STOP Program's patient portal. The STOP Program is a large-scale, population-based smoking cessation initiative operating in over 300 primary care settings across Ontario. It provides free nicotine replacement therapy and behavioural support through a digital portal that facilitates patient self-enrollment and systematic data collection. As part of this study, patients who score ≥8 on the AUDIT-C will be offered the opportunity to view a brief intervention (BI). Those with an AUDIT-C score ≥10 will receive a cautionary message along with tailored content designed to help reduce hazardous drinking. The intervention was developed based on a rapid review (PROSPERO: CRD42023445492) and a Delphi consensus process using the Behaviour Change Techniques Taxonomy V1. Key components include personalized feedback, normative comparisons, reflective prompts, and actionable behaviour change strategies. For patients scoring above a clinical threshold, additional messaging encourages caution regarding abrupt cessation and suggests consulting a healthcare provider. Our primary outcome is acceptance of the new online resource.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-13.
Status change: Not Yet Recruiting → Completed 2026-06-09
Trial Details
NCT Number NCT07228923
Lead Sponsor Centre for Addiction and Mental Health
Conditions Alcohol Misuse
Enrollment 77 participants
Start Date 2025-11-20
Primary Completion 2026-05-22 (estimated)
Study Completion 2026-05-22 (estimated)
Updated on ClinicalTrials.gov 2026-06-11