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,
Ames SC, Werch CE, Ames GE, Lange LJ, Schroeder DR, Hanson AC, Patten CA. Integrated smoking cessation and binge drinking intervention for young adults: a pilot investigation. Ann Behav Med. 2010 Dec;40(3):343-9. doi: 10.1007/s12160-010-9222-4. — View Citation
Beyer FR, Campbell F, Bertholet N, Daeppen JB, Saunders JB, Pienaar ED, Muirhead CR, Kaner EFS. The Cochrane 2018 Review on Brief Interventions in Primary Care for Hazardous and Harmful Alcohol Consumption: A Distillation for Clinicians and Policy Makers. Alcohol Alcohol. 2019 Jul 1;54(4):417-427. doi: 10.1093/alcalc/agz035. — View Citation
Centre for Health Protection, Department of Health. Alcohol Screening and Brief Intervention: A guide for use in primary care. 2017.
Cook JW, Fucito LM, Piasecki TM, Piper ME, Schlam TR, Berg KM, Baker TB. Relations of alcohol consumption with smoking cessation milestones and tobacco dependence. J Consult Clin Psychol. 2012 Dec;80(6):1075-85. doi: 10.1037/a0029931. Epub 2012 Sep 10. — View Citation
Correa-Fernandez V, Diaz-Toro EC, Reitzel LR, Guo L, Chen M, Li Y, Calo WA, Shih YT, Wetter DW. Combined treatment for at-risk drinking and smoking cessation among Puerto Ricans: A randomized clinical trial. Addict Behav. 2017 Feb;65:185-192. doi: 10.1016/j.addbeh.2016.10.009. Epub 2016 Oct 22. — View Citation
Deci E, Ryan R. Handbook of Self-determination. Research. Rochester, NY: University of Rochester Press; 2002.
Falk DE, Yi HY, Hiller-Sturmhofel S. An epidemiologic analysis of co-occurring alcohol and tobacco use and disorders: findings from the National Epidemiologic Survey on Alcohol and Related Conditions. Alcohol Res Health. 2006;29(3):162-71. — View Citation
Fraser D, Kobinsky K, Smith SS, Kramer J, Theobald WE, Baker TB. Five population-based interventions for smoking cessation: a MOST trial. Transl Behav Med. 2014 Dec;4(4):382-90. doi: 10.1007/s13142-014-0278-8. — View Citation
Hart CL, Davey Smith G, Gruer L, Watt GC. The combined effect of smoking tobacco and drinking alcohol on cause-specific mortality: a 30 year cohort study. BMC Public Health. 2010 Dec 24;10:789. doi: 10.1186/1471-2458-10-789. — View Citation
Joseph AM, Nelson DB, Nugent SM, Willenbring ML. Timing of alcohol and smoking cessation (TASC): smoking among substance use patients screened and enrolled in a clinical trial. J Addict Dis. 2003;22(4):87-107. doi: 10.1300/j069v22n04_08. — View Citation
Kahler CW, Metrik J, LaChance HR, Ramsey SE, Abrams DB, Monti PM, Brown RA. Addressing heavy drinking in smoking cessation treatment: a randomized clinical trial. J Consult Clin Psychol. 2008 Oct;76(5):852-62. doi: 10.1037/a0012717. — View Citation
Lam TH, Chan B, Ho SY, Chan WM. Stage of change for general health promotion action and health-related lifestyle practices in Chinese adults. Prev Med. 2004 Mar;38(3):302-8. doi: 10.1016/j.ypmed.2003.10.005. — View Citation
Leeman RF, McKee SA, Toll BA, Krishnan-Sarin S, Cooney JL, Makuch RW, O'Malley SS. Risk factors for treatment failure in smokers: relationship to alcohol use and to lifetime history of an alcohol use disorder. Nicotine Tob Res. 2008 Dec;10(12):1793-809. doi: 10.1080/14622200802443742. Erratum In: Nicotine Tob Res. 2009 Sep;11(9):1126. — View Citation
Li WHC, Ho KY, Wang MP, Cheung DYT, Lam KKW, Xia W, Cheung KY, Wong CKH, Chan SSC, Lam TH. Effectiveness of a Brief Self-determination Theory-Based Smoking Cessation Intervention for Smokers at Emergency Departments in Hong Kong: A Randomized Clinical Trial. JAMA Intern Med. 2020 Feb 1;180(2):206-214. doi: 10.1001/jamainternmed.2019.5176. — View Citation
Milosevic I, Levy HC, Alcolado GM, Radomsky AS. The Treatment Acceptability/Adherence Scale: Moving Beyond the Assessment of Treatment Effectiveness. Cogn Behav Ther. 2015;44(6):456-69. doi: 10.1080/16506073.2015.1053407. Epub 2015 Jun 19. — View Citation
Pengpid S, Peltzer K, Puckpinyo A, Viripiromgool S, Thamma-Aphiphol K, Suthisukhon K, Dumee D, Kongtapan T. Screening and concurrent brief intervention of conjoint hazardous or harmful alcohol and tobacco use in hospital out-patients in Thailand: a randomized controlled trial. Subst Abuse Treat Prev Policy. 2015 May 27;10:22. doi: 10.1186/s13011-015-0018-1. — View Citation
Przulj D, Hajek P, Snuggs S, McRobbie H. Changes in Alcohol Consumption During a Stop-Smoking Attempt and Differences Between Smokers Using Nicotine Replacement and Smokers Using Varenicline. Nicotine Tob Res. 2018 Apr 2;20(5):583-588. doi: 10.1093/ntr/ntx105. — View Citation
Rohsenow DJ, Monti PM, Colby SM, Gulliver SB, Sirota AD, Niaura RS, Abrams DB. Effects of alcohol cues on smoking urges and topography among alcoholic men. Alcohol Clin Exp Res. 1997 Feb;21(1):101-7. — View Citation
Rose JE, Brauer LH, Behm FM, Cramblett M, Calkins K, Lawhon D. Potentiation of nicotine reward by alcohol. Alcohol Clin Exp Res. 2002 Dec;26(12):1930-1. doi: 10.1097/01.ALC.0000040982.92057.52. No abstract available. — View Citation
Sayette MA, Martin CS, Wertz JM, Perrott MA, Peters AR. The effects of alcohol on cigarette craving in heavy smokers and tobacco chippers. Psychol Addict Behav. 2005 Sep;19(3):263-70. doi: 10.1037/0893-164X.19.3.263. — View Citation
The Lancet. Tobacco elimination: an economic and public health imperative. Lancet. 2017 Jan 21;389(10066):225. doi: 10.1016/S0140-6736(17)30132-0. Epub 2017 Jan 20. No abstract available. — View Citation
Thorne S. Interpretive description. Developing qualitative inquiry. 2008.
Toll BA, Martino S, O'Malley SS, Fucito LM, McKee SA, Kahler CW, Rojewski AM, Mahoney MC, Wu R, Celestino P, Seshadri S, Koutsky J, Hyland A, Cummings KM. A randomized trial for hazardous drinking and smoking cessation for callers to a quitline. J Consult Clin Psychol. 2015 Jun;83(3):445-54. doi: 10.1037/a0038183. Epub 2014 Nov 24. — View Citation
World Health Organization. AUDIT: The alcohol use disorders identification test: Guidelines for use in primary health care. World Health Organization; 2001.
Yardley MM, Mirbaba MM, Ray LA. Pharmacological Options for Smoking Cessation in Heavy-Drinking Smokers. CNS Drugs. 2015;29(10):833-45. doi: 10.1007/s40263-015-0284-5. — View Citation
* 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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
Completed |
NCT03999411 -
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
|
Phase 4 | |
Completed |
NCT04617444 -
The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function
|
N/A | |
Completed |
NCT02796391 -
Facilitating Smoking Cessation With Reduced Nicotine Cigarettes
|
Phase 2 | |
Completed |
NCT03397511 -
Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City
|
N/A | |
Not yet recruiting |
NCT05188287 -
A Culturally Tailored Smartphone Application for African American Smokers
|
N/A | |
Recruiting |
NCT05264428 -
The Effect of Honey on Lessening the Withdrawal Symptoms
|
N/A | |
Recruiting |
NCT05846841 -
Personalized Tobacco Treatment in Primary Care (MOTIVATE)
|
N/A | |
Completed |
NCT04133064 -
Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study
|
N/A | |
Completed |
NCT03187730 -
Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants
|
Phase 4 | |
Completed |
NCT03474783 -
To Explore the Factors Affecting the Effectiveness of Smoking Cessation
|
N/A | |
Completed |
NCT04635358 -
Feasibility Study of Smoking Cessation for the Staff of a Hospital Center
|
N/A | |
Terminated |
NCT03670264 -
BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation
|
N/A | |
Not yet recruiting |
NCT06307496 -
VIDeOS for Smoking Cessation
|
N/A | |
Completed |
NCT03206619 -
A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
|
||
Completed |
NCT02997657 -
Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT02905656 -
Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit
|
N/A | |
Completed |
NCT02239770 -
Pharmacokinetics of Nicotine Film in Smokers
|
N/A | |
Completed |
NCT02562521 -
A Smoking Cessation Intervention for Yale Dining Employees
|
Phase 4 | |
Recruiting |
NCT02422914 -
Benefits of Tobacco Free Cigarette
|
N/A |