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Completed

NCT Number: NCT05627765

An Integrated Smoking Cessation and Alcohol Intervention for Young People

The specific objectives of this study are to investigate the (1) feasibility, (2) preliminary effectiveness and (3) effect sizes of the integrated smoking cessation and alcohol intervention when compared to standalone smoking cessation (ST) and control among young adults in Hong Kong.

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Key information

Conditions

Smoking Cessation Alcohol Drinking Behavior Drinking Behavior Health Behavior

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • aged 18 to 25 years
  • smoked at least one traditional cigarette in the past 30 days
  • consumed at least one alcohol unit (one "alcohol unit" contains 10g of pure alcohol) in the past 30 days
  • speak Cantonese.

Exclusion criteria

  • have a compromised mental status and/or communication problems
  • participating in other smoking cessation and/or alcohol interventions

Treatment and study plan

Standard treatment (ST) arm

Behavioral

participants who are ready to quit smoking: a brief smoking cessation intervention based on the "5A" models and "STAR" method as quitting skills.

participants who are not yet ready to quit smoking: a brief smoking cessation intervention based on the "5R" models.

Integrated Intervention (II) arm

Behavioral

brief advice on alcohol use based on the "FRAMES" model and the brief smoking cessation intervention based on the "5A" and "5R" models.

Primary outcomes

  1. screening rate

    Time frame: From screening to the end of treatment after 6 months

    the number of smokers screened divided by the number of smokers available for screening

  2. eligibility rate

    Time frame: From screening to the end of treatment after 6 months

    the number of eligible smokers divided by the number of screened people

  3. consent rate

    Time frame: From screening to the end of treatment after 6 months

    the number of eligible smokers who agree to participate divided by the number of eligible smokers

  4. randomization rate

    Time frame: From screening to the end of treatment after 6 months

    the number of participants who are randomized divided by the number of eligible smokers who consent to participate

  5. attendance rate

    Time frame: From screening to the end of treatment after 6 months

    the number of participants who complete the intervention divided by the number of participants who are randomized into the treatment arms (ST and II)

  6. adherence to intervention

    Time frame: From screening to the end of treatment after 6 months

    the number of participants in the two treatment arms who practice the skills learned during the intervention divided by the number of participants in the two treatment arms

  7. retention rate

    Time frame: From screening to the end of treatment after 6 months

    the number of participants who remain in the study divided by the number of participants randomized

  8. completion rate

    Time frame: From screening to the end of treatment after 6 months

    the number of participants who complete the questionnaire divided by the number of questionnaires distributed

  9. missing data

    Time frame: From screening to the end of treatment after 6 months

    the percentage of missing data

  10. adverse events

    Time frame: From screening to the end of treatment after 6 months

    unfavorable or unintended events during the study period that were not present at baseline or appear to have worsened since baseline

Secondary outcomes

  1. Smoking quit rate

    Time frame: From screening to the end of treatment after 6 months

    the effect size of II on self-reported and biochemically validated quit rates for smoking at 6 months relative to ST and Control.

  2. alcohol quit rate

    Time frame: From screening to the end of treatment after 6 months

    the effect size of II on self-reported quit rate for alcohol at 6 months relative to ST and Control

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Food and Health Bureau, Hong Kong

Registry information

Official study title

An Integrated Smoking Cessation and Alcohol Intervention Among Hong Kong Chinese Young People: A Feasibility Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 28, 2022
Registry last updated
Jul 8, 2025

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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