What is the mechanism of action of this treatment?

The most common treatments for tobacco smoking include behavioral support and nicotine replacement therapy (NRT). Behavioral support, such as counseling and motivational interviewing, helps patients address the psychological and social factors that contribute to smoking. NRT provides a controlled dose of nicotine to alleviate withdrawal symptoms and cravings, making it easier for patients to quit. Combining these treatments is effective because it tackles both the mental and physical aspects of nicotine dependence, thereby enhancing the chances of successful smoking cessation.

What side effects are associated with this type of intervention?

Behavioral support for smoking cessation, such as counseling, typically has minimal side effects but may cause emotional discomfort. Nicotine replacement therapies (NRTs), including patches, gum, and lozenges, can cause skin irritation, mouth soreness, and throat irritation, respectively. Common side effects of NRTs also include nausea, dizziness, and insomnia, which are usually mild and temporary.

What prior FDA approvals exist?

The FDA has approved several treatments for tobacco smoking cessation that align with the interventions studied in the trial, such as behavioral support and nicotine replacement therapy (NRT). NRT products include nicotine patches, gum, lozenges, nasal spray, and inhalers, which help reduce withdrawal symptoms by providing a controlled dose of nicotine. Additionally, the FDA has approved medications like varenicline (Chantix) and bupropion (Zyban) that aid in smoking cessation by targeting nicotine receptors in the brain and reducing cravings. Combining these pharmacotherapies with behavioral support, such as counseling, has been shown to be more effective than using either approach alone.

What other types of research exist?

Promising novel alternatives for smoking cessation in 2024 include: <ol> <li>Text Messaging Interventions: Automated, personalized text messages providing motivational support and behavioral change suggestions.</li> <li>Mobile Apps: Smartphone applications offering real-time monitoring, notifications, and support for smoking cessation.</li> <li>Mindfulness and Yoga: Techniques to manage cravings and stress associated with quitting smoking.</li> <li>Motivational Interviewing: A counseling approach to build intrinsic motivation and resolve ambivalence about quitting.</li> <li>Online Support Programs: Web-based resources and social network interventions to provide community support and engagement.</li> <li>Exercise Interventions: Physical activity programs designed to reduce cravings and improve overall health during cessation.</li> </ol>

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Tobacco Cessation Interventions for Smoking Cessation (ScreenASSIST Trial)

Phase 4

Waitlist Available

Led By Nancy A Rigotti, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months - no longer in use after 7/6/2020

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests different ways to help smokers quit by using counseling, nicotine patches, and community service referrals. It targets smokers who are getting lung cancer screenings. The methods work by providing support, reducing cravings, and addressing other barriers to quitting.

Who is the study for?

This trial is for current smokers aged 50-80 who speak English or Spanish, have smoked recently, are scheduled for a low-dose CT lung cancer screening, and live in the USA. They must be able to give consent and communicate by phone. Those with certain medical conditions or without telephone access cannot join.

What is being tested?

The study tests how best to integrate smoking cessation help into lung cancer screenings. Participants will receive different lengths of counseling (via phone/video) and nicotine patch treatments, plus some may get referred to online community resources.

What are the potential side effects?

Possible side effects from the nicotine patch can include skin irritation at the patch site, dizziness, racing heartbeat, sleep problems or unusual dreams, headache, nausea, muscle pain and stiffness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months - no longer in use after 7/6/2020

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months - no longer in use after 7/6/2020

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months - no longer in use after 7/6/2020 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants With Self-reported Past 7-day Smoking Abstinence

Secondary study objectives

Number of Participants With Self-Reported Past 7-day Smoking Abstinence

Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half

Proportion of Patients Who Make an Intentional Attempt to Quit Smoking

Other study objectives

Biochemically-verified past 7-day abstinence from cigarette smoking

Side effects data

From 2020 Phase 4 trial • 1251 Patients • NCT03176784

31%

Nausea

27%

Insomnia

16%

Changes in Mood

10%

Skin Rash

Headache

Itching/Hives

100%

80%

60%

40%

20%

Study treatment Arm

Varenicline Only Extended Duration

Varenicline + Patch Standard Duration

Varenicline Only Standard Duration

Varenicline + Patch Extended Duration

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

8Treatment groups

Experimental Treatment

Group I: Short, Short, PresentExperimental Treatment3 Interventions

4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.

Group II: Short, Short, AbsentExperimental Treatment2 Interventions

4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.

Group III: Short, Long, PresentExperimental Treatment3 Interventions

4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.

Group IV: Short, Long, AbsentExperimental Treatment2 Interventions

4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.

Group V: Long, Short, PresentExperimental Treatment3 Interventions

8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.

Group VI: Long, Short, AbsentExperimental Treatment2 Interventions

8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.

Group VII: Long, Long, PresentExperimental Treatment3 Interventions

8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.

Group VIII: Long, Long, AbsentExperimental Treatment2 Interventions

8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotine patch

2015

Completed Phase 4

~6130

Counseling

2017

Completed Phase 4

~1830

Community Resource

2019

Completed Phase 4

~650

Do I qualify?Apply below to find out

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

The most common treatments for tobacco smoking include behavioral support and nicotine replacement therapy (NRT). Behavioral support, such as counseling and motivational interviewing, helps patients address the psychological and social factors that contribute to smoking. NRT provides a controlled dose of nicotine to alleviate withdrawal symptoms and cravings, making it easier for patients to quit. Combining these treatments is effective because it tackles both the mental and physical aspects of nicotine dependence, thereby enhancing the chances of successful smoking cessation.

Emerging drugs for the treatment of tobacco dependence: 2014 update.Combination treatment for nicotine dependence: state of the science.Smoking cessation guidelines: evidence-based recommendations of the French Health Products Safety Agency.