Smoking Cessation Clinical Trial
Official title:
Development and a Pilot Randomized Controlled Trial of a Brief Alcohol Intervention During Smoking Cessation Treatment Delivered by Healthcare Professionals
Verified date | March 2023 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to develop a theory-driven, brief alcohol intervention protocol for HCPs to deliver the intervention for co-users of tobacco and alcohol during smoking cessation treatment. The primary hypothesis is that smoking cessation treatment including the alcohol intervention will increase tobacco abstinence and reduce alcohol drinking. Our second hypothesis is that the brief intervention to deal with alcohol use will be feasible during smoking cessation treatment and be widely accepted by smokers.
Status | Completed |
Enrollment | 100 |
Est. completion date | October 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - Self-report tobacco use in the past month - Aged 18 or above - Currently using or recently enrolled in local smoking cessation service - Able to communicate in Cantonese/Mandarin and read Chinese - Self-report alcohol use in either of the four drinking levels: - Lower-risk of drinking problems (AUDIT score 1-7) - Drinking at increasing risk (AUDIT score 8-15) - Harmful drinking (AUDIT score 16-19) - Having drinking dependence (AUDIT score >=20) - Self-report one of the following: - In previous quit attempts in lifetime, have smoked few cigarettes due to drinking alcohol (but not relapse) - In the past 3 months, have felt an urge to smoking during/ after drinking - In the past 3 months, smoked when drinking - Smoked more cigarettes when drinking, compared to the day of smoke only - In general, the drinking habit influenced the motivation to quit smoking |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The feasibility of the intervention (intervention group only) | The feasibility will be assessed with the time required for the intervention and HCPs' compliance enquired in the action plan. | At 2 month follow-up. | |
Other | The acceptability of the intervention (intervention group only) | The acceptability will be assessed by the Treatment Acceptability/ Adherence Scale (TAAS) [24]. TAAS is a 7-point likert scale which ranged from 1 (disagree strongly) to 7 (agree strongly). It contains 11-item (e.g. ".The intervention is suitable for changing my drinking habits."). Higher score indicate higher degree of acceptability in this scale. Besides the TAAS, there are 6 additional open-ended questions will be used to collect participants' attitudes and feedback towards the intervention (e.g. "Please describe the most effective and unnecessary parts of the alcohol control brief intervention"). | At 2 month follow-up. | |
Primary | Number of Participants with Self-reported Tobacco Abstinence in Past 7 Days | Number of Participants with Self-reported Tobacco Abstinence in Past 7 Days | At 2 month follow-up. | |
Primary | Biochemically Validated tobacco abstinence at 2 month follow-up | Participants who report tobacco abstinence will be invited for a biochemical validation which defined participants as validated quitters if his/her exhaled carbon monoxide is 4ppm or below with a Bedfont Smokerlyzer or 30ng/ml below with the iScreen Oral Fluid Device (OFD) Cotinine Saliva Test Kit. | At 2 month follow-up. | |
Primary | Alcohol consumption (alcohol units) in past week; | The alcohol consumption (alcohol units) in past week; | At 2 month follow-up. | |
Primary | AUDIT score | The AUDIT score will be measured via the AUDIT questionnaire | At 2 month follow-up. |
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