What side effects are associated with this type of intervention?

Common side effects of smoking cessation treatments vary by type. Nicotine replacement therapies (NRTs) like patches can cause skin irritation, dizziness, and sleep disturbances. Medications such as varenicline may lead to nausea, vivid dreams, and mood changes, while bupropion can cause insomnia and dry mouth. Behavioral approaches, including technology-assisted interventions like mobile apps and automated messaging systems, generally have fewer physical side effects but may lead to increased anxiety or frustration if the user finds the technology challenging to use. It is important to discuss these potential side effects with a healthcare provider to choose the most suitable treatment.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for smoking cessation, including nicotine replacement therapy (NRT) products like patches, gums, and lozenges, as well as prescription medications such as bupropion (Zyban) and varenicline (Chantix). These treatments have been shown to be effective in helping individuals quit smoking. While the use of technology to support smoking cessation, such as automated video-assisted treatments, is an emerging area of study, the FDA has not yet specifically approved any technology-based treatments for smoking cessation. However, ongoing research and pilot trials are exploring the potential of these innovative approaches to enhance traditional pharmacotherapy and behavioral interventions.

What other types of research exist?

Promising, novel alternatives to automated treatment for smoking cessation in 2024 include: 1) Mobile health solutions that complement psychopharmacology, which have shown greater efficacy for achieving long-term tobacco abstinence. 2) Text-messaging programs like SmokefreeMOM, which are effective and feasible for specific populations such as pregnant smokers. 3) Telemedicine-based smoking cessation support programs, which are expected to be as effective as face-to-face programs. 4) Machine learning models that predict smoking cessation outcomes, potentially allowing for personalized treatment plans. 5) Supportive chatbots integrated into smoking cessation apps, which increase user engagement and short-term quit success. 6) Peer mentoring combined with automated text messages, which has shown increased smoking abstinence compared to automated messages alone.

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Nicotine Replacement Therapy

Automated Smoking Cessation for People Living With HIV

N/A

Waitlist Available

Led By Damon J Vidrine, Dr.PH

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

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

Current use of smoking cessation medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if an automated system can help people quit smoking more effectively than traditional methods that require more resources.

Who is the study for?

This trial is for people living with HIV who currently smoke more than 5 cigarettes a day, have smoked at least 100 in their lifetime, and are ready to quit within a week of joining. Participants must own a smartphone compatible with the study app, speak English or Spanish, and have an email address. Pregnant or breastfeeding individuals, those on cessation meds or in another smoking study can't join.

What is being tested?

The study is testing if an Automated Video-Assisted Smoking Treatment using smartphones helps people stop smoking better than Standard Treatment that requires more resources. It involves nicotine patches, lozenges, counseling, and automated treatment delivered through a smartphone.

What are the potential side effects?

Possible side effects from the interventions may include skin irritation from nicotine patches; mouth problems like soreness or heartburn from lozenges; and sleep disturbances or nausea from both nicotine products.

Eligibility Criteria

Exclusion Criteria

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

Select...

I am currently using medication to help me stop smoking.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Self Reported 7 Day Abstinence Smoking Status

Secondary study objectives

30 Day Smoking Abstinence

Continuous Smoking Abstinence

Self Reported 24 Hours Smoking Abstinence

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Automated TreatmentExperimental Treatment3 Interventions

Participants randomized to Automated Treatment (AT) will be given a 10-week supply of nicotine patches and lozenges. AT will also comprise of: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and/or negative affect/stress; 2) 26 weeks of on-demand access to treatment content; 3) 26 weeks of text content

Group II: Standard TreatmentActive Control3 Interventions

Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with their state's tobacco quitline services and will complete weekly 4-item smartphone assessments electronically for 26 weeks. The weekly assessments consist of questions on smoking status, motivation, self-efficacy, and perceived stress.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotine patch

2015

Completed Phase 4

~6130

Nicotine lozenge

2019

Completed Phase 4

~1940

Smartphone-delivered automated treatment

2017

Completed Phase 4

~40

0 / 1Eligibility 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 work through various mechanisms. Behavioral therapies like cognitive-behavioral therapy (CBT) and motivational interviewing (MI) help patients identify and manage triggers, develop coping strategies, and build motivation for quitting. Contingency management (CM) uses positive reinforcement to encourage abstinence. Pharmacologic treatments, such as nicotine replacement therapy (NRT), varenicline, and bupropion, reduce withdrawal symptoms and cravings by targeting nicotine receptors in the brain. Technology-based interventions, including automated treatments and mobile phone-based messaging, provide continuous, personalized support and real-time feedback, which are essential for sustaining long-term smoking cessation. These mechanisms are vital as they address both the psychological and physiological aspects of nicotine addiction, increasing the likelihood of successful quitting.

Mobile phone-based messaging for tobacco cessation in low and middle-income countries: A systematic review.Contingency management for tobacco smoking during opioid addiction treatment: Implementation challenges.The natural history of efforts to stop smoking: a prospective cohort study.