What side effects are associated with this type of intervention?

Common treatments for smoking cessation include pharmacological options like varenicline, bupropion, and nicotine replacement therapies (NRTs), as well as behavioral support such as counseling. Varenicline can cause nausea, insomnia, and vivid dreams. Bupropion may lead to insomnia, dry mouth, and an increased risk of seizures. NRTs, including patches, gums, and lozenges, can cause skin irritation, mouth soreness, and gastrointestinal issues. Behavioral interventions, such as counseling via videoconferencing, generally have minimal side effects but may include emotional discomfort as individuals confront their smoking habits.

What prior FDA approvals exist?

The FDA has approved several treatments for smoking cessation, including nicotine replacement therapies (NRT) such as patches, gums, and lozenges, which help reduce withdrawal symptoms by providing a controlled dose of nicotine. Bupropion (Zyban) is an antidepressant that has been approved for smoking cessation due to its ability to reduce cravings and withdrawal symptoms. Varenicline (Chantix) is another FDA-approved medication that works by targeting nicotine receptors in the brain to reduce the pleasure derived from smoking and alleviate withdrawal symptoms. Behavioral support, including counseling and digital interventions like videoconferencing, is often recommended in combination with these pharmacotherapies to enhance quit rates.

What other types of research exist?

Promising, novel alternatives to behavioral support via videoconferencing for smoking cessation in 2024 include: 1) Text messaging programs like Text4Coach (T4C) and Text&Quit (T&Q) that connect smokers to quitline counseling or smoking cessation programs. 2) Telemedicine-based smoking cessation support, which offers flexibility and has shown comparable efficacy to face-to-face programs. 3) Web-based live chat coaching, which uses motivational interviewing and behavior change techniques to provide personalized support. 4) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which can be integrated with smoking cessation efforts to improve overall treatment outcomes.

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Videoconferencing Smoking Cessation Program for Smoking

N/A

Recruiting

Led By Stephanie L Marhefka, PhD

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

pregnant, breastfeeding, or have other contraindications to NRT

inability to communicate coherently in English during the video-conferencing test or other pre-enrollment interactions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study day 360

Summary

This trial tests a program to help people living with HIV stop smoking by using group video calls, nicotine patches, and quitting advice. The Positively Smoke Free (PSF) program is a biobehavioral cessation intervention specifically designed for people with HIV, with a growing evidence base.

Who is the study for?

The Positively Quit Trial is for adults over 18 living in the US with certain chronic conditions who smoke cigarettes and are motivated to quit. Participants must have internet access, be able to use Zoom, speak English, and not be pregnant or breastfeeding. They cannot be using other tobacco treatments.

What is being tested?

This study tests a smoking cessation program delivered via videoconferencing against an Attention Matched Control condition that doesn't focus on quitting but has equal contact hours. Both groups get nicotine patches and advice to quit across 12 sessions.

What are the potential side effects?

Possible side effects may include those associated with nicotine replacement therapy such as skin irritation from patches, dizziness, racing heartbeat, sleep problems or unusual dreams.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant, breastfeeding, and have no issues with nicotine replacement therapy.

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I can communicate clearly in English during video calls.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study day 360

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study day 360

This trial's timeline: 3 weeks for screening, Varies for treatment, and study day 360 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biochemically confirmed 30-day point prevalence abstinence (BC30ppa) day 360

Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 360

Biochemically confirmed sustained abstinence (BC.SA) day 360

Secondary study objectives

Biochemically confirmed 30-day point prevalence abstinence (BC30ppa) day 180

Biochemically confirmed 30-day point prevalence abstinence (BC30ppa) days 90

Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 180

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Positively MeExperimental Treatment1 Intervention

Positively Me is a 12-session (8 \[1.5\] hour main sessions plus four booster sessions) intervention guided by Social Cognitive Theory to promote smoking cessation in people with certain health conditions.

Group II: Positively LivingPlacebo Group1 Intervention

Positively Living is a modified updated version of a healthy living intervention based on Social Cognitive Theory that is designed for people with certain health conditions and attention-matched to the experimental condition (8 \[1.5\] hour main sessions plus four booster sessions).

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for smoking cessation include behavioral support and pharmacotherapy. Behavioral support, such as cognitive-behavioral therapy (CBT) and motivational interviewing (MI), helps patients change smoking-related behaviors and thought patterns. This can be delivered via videoconferencing, making it accessible for those with chronic conditions. Pharmacotherapy, including nicotine replacement therapy (NRT), bupropion, and varenicline, reduces withdrawal symptoms and cravings. Combining these approaches is often more effective than using either alone, as it addresses both the psychological and physiological aspects of addiction. This comprehensive approach is crucial for patients as it increases the likelihood of successful smoking cessation.

[Cigarette smoking. A pilot project of dehabituation and experimental research].Mindfulness-Based Smoking Cessation Delivered Through Telehealth and Text Messaging for Low-Income Smokers: Protocol for a Randomized Controlled Trial.