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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 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.

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.

Find a Location

Who is running the clinical trial?

Lehigh UniversityLead Sponsor
22 Previous Clinical Trials
4,144 Total Patients Enrolled
University of Kansas Medical CenterOTHER
511 Previous Clinical Trials
176,128 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,592 Previous Clinical Trials
3,328,104 Total Patients Enrolled

Media Library

All Nations Breath of Life (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04931810 — N/A
Smoking Cessation Research Study Groups: All Nations Breath of Life
Smoking Cessation Clinical Trial 2023: All Nations Breath of Life Highlights & Side Effects. Trial Name: NCT04931810 — N/A
All Nations Breath of Life (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04931810 — N/A
~37 spots leftby Mar 2025