What side effects are associated with this type of intervention?

Common treatments for smoking cessation include nicotine replacement therapies (NRTs) and behavioral approaches. NRTs, such as nicotine gum, patches, nasal sprays, vapor inhalers, and sublingual tablets, can cause side effects like dizziness, headaches, throat irritation, skin irritation, and abnormal dreams. Behavioral approaches, including counseling, mindfulness, and exercise interventions, generally have fewer physical side effects but may require significant time and effort commitment. Combining these methods can improve cessation rates and manage withdrawal symptoms more effectively.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for smoking cessation, including nicotine replacement therapies (NRTs) like patches, gums, and lozenges, as well as prescription medications such as bupropion and varenicline. These treatments are often used in combination with behavioral modification techniques, which have been shown to enhance quit rates. Behavioral interventions, such as individual counseling, group therapy, and digital platforms like mobile apps and web resources, are integral components of comprehensive smoking cessation programs. The All Nations Breath of Life (ANBL) smoking cessation program, which focuses on behavioral modification, aligns well with these FDA-approved approaches by incorporating culturally tailored behavioral support to help individuals quit smoking.

What other types of research exist?

Promising, novel alternatives to the All Nations Breath of Life (ANBL) smoking cessation program include: 1) The No Smoking Clinic, which showed a 25% quit rate at 12 months. 2) The Stanford Quit Kit, a self-administered program with a 10.6% abstinence rate at six months. 3) Mindfulness Training for Smokers (MTS), which has been tested in disadvantaged populations. 4) Text messaging programs like QuitNowTXT, which have shown feasibility and acceptability in different countries. 5) Community programs with written commitments and support materials, which reported a 29% quit rate after one year.

← Back to Search

Behavioral Intervention

Smoking Cessation Program for Quitting Smoking (ANBL-I Trial)

N/A

Recruiting

Led By Christine M Daley, PhD

Research Sponsored by Lehigh University

Eligibility Criteria Checklist

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

Must have

Age 18 or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7-day point prevalence abstinence at 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the ANBL program, a quit-smoking plan for American Indian communities. It includes group meetings led by community members, phone support, educational materials with cultural elements, and optional medications. The goal is to help participants quit smoking through community support and personal counseling. The ANBL program was created by the American Indian Health Research and Education Alliance (AIHREA) to address the high smoking rates among American Indians.

Who is the study for?

This trial is for self-identified American Indians aged 18 or older who smoke at least one cigarette per day and are planning to quit. Participants must have a home address, telephone number, and be willing to participate in the program and follow-up for 6 months.

What is being tested?

The All Nations Breath of Life (ANBL) smoking cessation program is being tested across four sites—two reservation and two urban—to see how well it works outside of reservations. The study allows some flexibility for communities to adapt parts of the intervention while following core guidelines.

What are the potential side effects?

Since ANBL is a behavioral intervention focused on smoking cessation rather than a drug, it does not have traditional side effects like medications do. However, participants may experience symptoms related to nicotine withdrawal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30-day point prevalence and continuous abstinence at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30-day point prevalence and continuous abstinence at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30-day point prevalence and continuous abstinence at 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Smoking Cessation

Secondary study objectives

Smoking Cessation 2

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: All Nations Breath of LifeExperimental Treatment1 Intervention

ANBL is a culturally tailored smoking cessation program that incorporates group-based and individual counseling. Participants may elect to take pharmacotherapy, but are not required to do so.

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

Behavioral modification techniques, such as cognitive-behavioral therapy (CBT), motivational interviewing (MI), and mindfulness-based interventions, are common treatments for smoking cessation. CBT helps patients identify and manage triggers and develop coping strategies, while MI enhances motivation to quit by resolving ambivalence and encouraging commitment to change. Mindfulness-based interventions teach patients to manage cravings and stress through mindfulness practices. These methods are crucial as they address the psychological and behavioral aspects of addiction, which are often the most challenging barriers to quitting smoking.

Smoking intervention in the workplace using videotapes and nicotine chewing gum.The natural history of efforts to stop smoking: a prospective cohort study.Methodological issues in measuring treatment outcome in adolescent smoking cessation studies.