Dataset Information

Design of a randomized controlled trial of smoking cessation medications for alcohol reduction among HIV-positive heavy drinkers and daily smokers in St. Petersburg, Russia.

ABSTRACT:

Background

HIV, heavy drinking, and smoking are all pro-inflammatory and increase risk for coronary heart disease (CHD). Interventions that reduce alcohol use, smoking, or both in HIV-positive people could lower inflammation, CHD and death risk. Varenicline and cytisine are proven therapies for smoking cessation and may also reduce alcohol consumption. The comparative efficacy of varenicline and cytisine to reduce alcohol consumption has not been tested, nor has their comparative effectiveness been reported for smoking.

Objective

This paper describes the protocol of the Studying Partial agonists for Ethanol and Tobacco Elimination in Russians with HIV (St PETER HIV), a four-arm parallel-group randomized controlled trial comparing effects of varenicline, cytisine, and nicotine replacement therapy (NRT).

Methods

The study is recruiting four hundred HIV-positive heavy drinking smokers interested in cutting down on alcohol and/or tobacco in St. Petersburg, Russia. Participants are randomly assigned to receive either active varenicline + NRT placebo, varenicline placebo + active NRT, active cytisine + NRT placebo, cytisine placebo + active NRT. All participants receive evidence-based counseling for alcohol and tobacco use, one active medication, and one placebo. Outcomes are: 1) % heavy drinking days in the past month (primary study outcome at three months) and alcohol craving; 2) cigarettes per day (primary smoking outcome at 3 months) and 7-day point prevalence abstinence and; 3) inflammation, CHD risk, and mortality risk.

Conclusion

St PETER HIV addresses the paucity of randomized controlled trial data to guide treatment of alcohol consumption and smoking in HIV-positive heavy drinking smokers.

SUBMITTER: Tindle HA

PROVIDER: S-EPMC7889999 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Publications

Design of a randomized controlled trial of smoking cessation medications for alcohol reduction among HIV-positive heavy drinkers and daily smokers in St. Petersburg, Russia.

Tindle Hilary A HA Freiberg Matthew S MS Gnatienko Natalia N Blokhina Elena E Cheng Debbie M DM Yaroslavtseva Tatiana T Bendiks Sally S Winter Michael M Krupitsky Evgeny E Samet Jeffrey H JH

Contemporary clinical trials communications 20200716

<h4>Background</h4>HIV, heavy drinking, and smoking are all pro-inflammatory and increase risk for coronary heart disease (CHD). Interventions that reduce alcohol use, smoking, or both in HIV-positive people could lower inflammation, CHD and death risk. Varenicline and cytisine are proven therapies for smoking cessation and may also reduce alcohol consumption. The comparative efficacy of varenicline and cytisine to reduce alcohol consumption has not been tested, nor has their comparative effecti ...[more]

PMID: 33659761

Similar Datasets

Project description:BackgroundHeavy drinking (HD) is far more common among smokers compared with nonsmokers and interferes with successful smoking cessation. Alcohol-focused smoking cessation interventions delivered by counselors have shown promise, but digital versions of these interventions-which could have far greater population reach-have not yet been tested.ObjectiveThis pilot randomized controlled trial aimed to examine the feasibility, acceptability, and effect sizes of an automated digital smoking cessation program that specifically addresses HD using an interactive web-based intervention with an optional text messaging component.MethodsParticipants (83/119, 69.7% female; 98/119, 82.4% white; mean age 38.0 years) were daily smokers recruited on the web from a free automated digital smoking cessation program (BecomeAnEX.org, EX) who met the criteria for HD: women drinking 8+ drinks/week or 4+ drinks on any day and men drinking 15+ drinks/week or 5+ drinks on any day. Participants were randomized to receive EX with standard content (EX-S) or an EX with additional content specific to HD (EX-HD). Outcomes were assessed by web-based surveys at 1 and 6 months.ResultsParticipants reported high satisfaction with the website and the optional text messaging component. Total engagement with both EX-S and EX-HD was modest, with participants visiting the website a median of 2 times, and 52.9% of the participants enrolled to receive text messages. Participants in both the conditions showed substantial, significant reductions in drinking across 6 months of follow-up, with no condition effects observed. Although smoking outcomes tended to favor EX-HD, the condition effects were small and nonsignificant. A significantly smaller proportion of participants in EX-HD reported having a lapse back to smoking when drinking alcohol (7/58, 16%) compared with those in EX-S (18/61, 41%; χ21=6.2; P=.01).ConclusionsThis is the first trial to examine a digital smoking cessation program tailored to HD smokers. The results provide some initial evidence that delivering such a program is feasible and may reduce the risk of alcohol-involved smoking lapses. However, increasing engagement in this and other web-based interventions is a crucial challenge to address in future work.Trial registrationClinicalTrials.gov NCT03068611; https://clinicaltrials.gov/ct2/show/NCT03068611.

Project description:Varenicline and bupropion, efficacious smoking cessation medications, have had suboptimal impact due to barriers at the patient, practitioner and system level. This study explored the feasibility of a web-assisted tobacco intervention offering free prescription smoking cessation medication by mail if the smoker visited a physician for authorization.Adult Ontarians, smoking at least 10 cigarettes daily, intending to quit within 30 days, with no contraindications to bupropion or varenicline were eligible. After an online assessment, eligible participants received an electronic personalized printable prescription form for a 12-week course of varenicline or bupropion to bring to a physician within 3 weeks for authorization, if appropriate. The physician's office faxed prescriptions to an online pharmacy that couriered medication to the patient following medication counselling by telephone. Weekly motivational emails were sent during treatment. Participants were asked to complete follow-up questionnaires online at 7, 11, 15 and 41 weeks after enrollment.In total, 1214 individuals submitted an online assessment from April to September 2010 and 73.6 % (95 % confidence interval (CI)?=?71.1-76.1 %; n?=?893) were eligible. At least 65.8 % (95 % CI?=?62.7-68.9 %; n?=?588) of eligible participants subsequently visited a physician and 58.7 % (95 % CI?=?55.5-61.9 %; n?=?524) received medication (50.6 % varenicline [n?=?265] and 49.4 % bupropion [n?=?259]). Reasons for not filling a prescription were failure to visit a physician (80.1 %; 95 % CI?=?73.8-86.5 %; n?=?121), physician not prescribing the medication (15.9 %; 95 % CI?=?10.1-21.7 %; n?=?24) or other reasons (4.0 %; 95 % CI?=?0.9-7.1 %; n?=?6). Follow-up response rate was 66.7 % (95 % CI?=?63.7-69.8 %; n?=?596). Minimal issues were encountered with printing the prescription or medication delivery.This study establishes the feasibility of using the Internet and free medication to enable smokers to engage physicians to treat this addiction. Implementation of this intervention can be scaled up by leveraging existing healthcare systems to treat smokers on a population level. Further evaluation in a randomized controlled trial is necessary.ClinicalTrials.gov Identifier NCT01023659.

Dataset Information

Design of a randomized controlled trial of smoking cessation medications for alcohol reduction among HIV-positive heavy drinkers and daily smokers in St. Petersburg, Russia.

Background

Objective

Methods

Conclusion

Publications

Design of a randomized controlled trial of smoking cessation medications for alcohol reduction among HIV-positive heavy drinkers and daily smokers in St. Petersburg, Russia.

Similar Datasets

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