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OpenTrials
Completed

NCT Number: NCT07228923

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

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.

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Key information

Conditions

Alcohol Misuse Behavior Health Behavior Smoking Cessation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • seeking treatment for smoking cessation
  • enrolling via the patient self-serve portal
  • AUDIT-10 score of 8 or higher

Exclusion criteria

  • none

Treatment and study plan

Brief alcohol intervention

Behavioral

The intervention is a prompt that that appears as an alert message in the patient portal, recommending the alcohol intervention.

Primary outcomes

  1. overall acceptance rate

    Time frame: Immediate: acceptance of offered intervention during baseline survey data collection (following eligibility determination in same survey).

Secondary outcomes

  1. Provider-initiated discussion of alcohol use at the first clinical treatment visit

    Time frame: Assessed at the first clinical visit within 2 months after baseline survey completion.

    Provider-initiated discussion of alcohol use at the first clinical treatment visit. Following self-enrolment, providers reviewed participant questionnaires prior to or during the first visit and were asked to record whether they had discussed alcohol use with the participant. This outcome is captured via the portal data-collection system.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

Evaluation of a Theory Informed Intervention to Reduce Hazardous Alcohol Consumption Among Treatment Seeking Smokers

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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