Alcohol Control in Smoking Cessation

NCT05430529 | Completed

• 1 other identifier: HKU_alcoholcontrol_protocol_v1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation

Keywords

Alcohol Control; Intervention; Smoking Cessation; WhatsApp

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• Alcohol consumption (alcohol units) in past week;

  The alcohol consumption (alcohol units) in past week;

  At 2 month follow-up.

• AUDIT score

  The AUDIT score will be measured via the AUDIT questionnaire

  At 2 month follow-up.

Other Outcomes (2)

• The feasibility of the intervention (intervention group only)

  At 2 month follow-up.

• The acceptability of the intervention (intervention group only)

  At 2 month follow-up.

Study Arms (2)

Brief Alcohol Intervention for Intervention Group

EXPERIMENTAL

During the face-to-face smoking cessation counseling session, HCPs will first play a 2 - 3 minutes short video with electronic devices to participants who are allocated to intervention group. After the short video, HCPs will ask participants to share their thoughts and willingness of alcohol control. Participants are expected to show 4 responses: (1) refuse to attempt alcohol control; agree to attempt alcohol control that (2) quit drinking totally, (3) quit drinking for 2 weeks, or (4) reduce the alcohol consumption. HCPs will deliver personalized advice according to participants' choices and encourage them to receive the WhatsApp message reminders. In all participants, HCPs will invite them to receive WhatsApp messages reminders for incoming 4 weeks (3 messages per week). Nevertheless, HCPs can also choose to provide AUDIT-based brief intervention to the participants.

Behavioral: Standard Smoke Cessation Service; Behavioral: Brief Alcohol Intervention for Intervention Group

Short Advice for Control Group

ACTIVE COMPARATOR

If the control group participant encountering difficulties in smoke cessation caused by alcohol usage, HCP will provide short advice to them. Participant will be urged not to drink during smoke quitting. If drinking is unavoidable, participant should not drink exceed the low-risk drinking portion recommended by Department of Health, which is 2 standard alcohol units for men and 1 stand alcohol unit for women per day. HCPs will remind participants to aware their drinking portion, in order to quit smoke successfully.

Behavioral: Standard Smoke Cessation Service; Behavioral: Short Advice for Control Group

Interventions

Standard Smoke Cessation Service BEHAVIORAL

Both of the intervention group and control group will receive standard smoke cessation service, which is same as usual practice.

Brief Alcohol Intervention for Intervention Group; Short Advice for Control Group

Short Advice for Control Group BEHAVIORAL

If the control group participant encountering difficulties in smoke cessation caused by alcohol usage, HCP will provide short advice to them. Participant will be urged not to drink during smoke quitting. If drinking is unavoidable, participant should not drink exceed the low-risk drinking portion recommended by Department of Health, which is 2 standard alcohol units for men and 1 stand alcohol unit for women per day. HCPs will remind participants to aware their drinking portion, in order to quit smoke successfully.

Short Advice for Control Group

Brief Alcohol Intervention for Intervention Group BEHAVIORAL

During the face-to-face smoking cessation counseling session, HCPs will first play a 2 - 3 minutes short video with electronic devices to participants who are allocated to the intervention group. After the short video, HCPs will ask participants to share their thoughts and willingness of alcohol control. Participants are expected to show 4 responses: (1) refuse to attempt alcohol control; agree to attempt alcohol control that (2) quit drinking totally, (3) quit drinking for 2 weeks, or (4) reduce the alcohol consumption. HCPs will deliver personalized advice according to participants' choices and encourage them to receive the WhatsApp message reminders. In all participants, HCPs will invite them to receive WhatsApp messages reminders for incoming 4 weeks (3 messages per week). In addition, HCPs can choose to discuss with participants the reasons for consuming alcohol. Nevertheless, HCPs can also choose to provide AUDIT-based brief intervention to the participants.

Brief Alcohol Intervention for Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation

Hong Kong, Hong Kong

Location

Related Publications (25)

• 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.

  PMID: 17373404 BACKGROUND

• World Health Organization. AUDIT: The alcohol use disorders identification test: Guidelines for use in primary health care. World Health Organization; 2001.

  BACKGROUND

• 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.

  PMID: 21184680 BACKGROUND

• 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.

  PMID: 28118898 BACKGROUND

• 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.

  PMID: 12500124 BACKGROUND

• 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.

  PMID: 22963593 BACKGROUND

• 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.

  PMID: 9046380 BACKGROUND

• 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.

  PMID: 16187804 BACKGROUND

• 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.

  PMID: 25584087 BACKGROUND

• 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.

  PMID: 19023831 BACKGROUND

• 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.

  PMID: 14723480 BACKGROUND

• 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.

  PMID: 26507831 BACKGROUND

• 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.

  PMID: 31062859 BACKGROUND

• 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.

  PMID: 18837602 BACKGROUND

• 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.

  PMID: 25419583 BACKGROUND

• 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.

  PMID: 20730517 BACKGROUND

• 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.

  PMID: 27825036 BACKGROUND

• 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.

  PMID: 26013537 BACKGROUND

• Centre for Health Protection, Department of Health. Alcohol Screening and Brief Intervention: A guide for use in primary care. 2017.

  BACKGROUND

• Deci E, Ryan R. Handbook of Self-determination. Research. Rochester, NY: University of Rochester Press; 2002.

  BACKGROUND

• 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.

  PMID: 31790546 BACKGROUND

• 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.

  PMID: 14766112 BACKGROUND

• 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.

  PMID: 28521015 BACKGROUND

• 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.

  PMID: 26091250 BACKGROUND

• Thorne S. Interpretive description. Developing qualitative inquiry. 2008.

  BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Interventions

Control Groups; Ethanol; Methods

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All participants will be followed up via telephone by an allocation-blinded interviewer at 2-month after the random group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A 2-arm, parallel, single-blinded pilot randomized controlled trial to examine the feasibility, acceptability and potential efficacy of implementing the brief alcohol intervention in co-users of tobacco and alcohol.

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 24, 2022
• Study Start: June 17, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

HK (1)